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ALERT: U.S. Boxed Warning
The FDA-approved labeling includes a boxed warning. See Warnings/Precautions section for a concise summary of this information. For verbatim wording of the boxed warning, consult the product labeling or www.fda.gov.
Pronunciation
(ox AL i pla tin)
Generic Available (U.S.)
Yes
Index Terms
U.S. Brand Names
Canadian Brand Names
Pharmacologic Category
Pharmacologic Category Synonyms
Use: Labeled Indications
Treatment of stage III colon cancer (adjuvant) and advanced colorectal cancer
Use: Unlabeled/Investigational
Treatment of esophageal cancer, gastric cancer, hepatobiliary cancer, non-Hodgkin's lymphoma, ovarian cancer, pancreatic cancer, testicular cancer
Pregnancy Risk Factor
D
Pregnancy Considerations
Decreased fetal weight, decreased ossification, and increased fetal deaths were observed in animal studies at one-tenth the equivalent human dose. There are no adequate and well-controlled studies in pregnant women. Women of childbearing potential should be advised to avoid pregnancy and use effective contraception during treatment.Canadian labeling: Use in pregnant women is contraindicated in the Canadian labeling. Males should be advised not to father children during and for up to 6 months following therapy. May cause permanent infertility in males. Prior to initiating therapy, advise males desiring to father children, to seek counseling on sperm storage.
Lactation
Excretion in breast milk unknown/not recommended
Breast-Feeding Considerations
Due to the potential for serious adverse reactions in the nursing infant, breast-feeding is not recommended.
Contraindications
Hypersensitivity to oxaliplatin, other platinum-containing compounds, or any component of the formulation
Canadian labeling: Additional contraindications (not in U.S. labeling): Pregnancy, breast-feeding; severe renal impairment (Clcr <30 mL/minute)
Warnings/Precautions
Boxed warnings:
• Anaphylaxis: See “Concerns related to adverse effects” below.
Special handling:
• Hazardous agent: Use appropriate precautions for handling and disposal.
Concerns related to adverse effects:
• Anaphylaxis: [U.S. Boxed Warning]: Anaphylactic/anaphylactoid reactions may occur within minutes of oxaliplatin administration; symptoms may be managed with epinephrine, corticosteroids, and antihistamines. Grade 3 or 4 hypersensitivity has been observed. Allergic reactions may occur with any cycle and may include bronchospasm (rare), erythema, hypotension (rare), pruritus, rash, and/or urticaria.
• Neuropathy: Two different types of peripheral sensory neuropathy may occur: First, an acute (within first 2 days), reversible (resolves within 14 days), with primarily peripheral symptoms that are often exacerbated by cold (may include pharyngolaryngeal dysesthesia); avoid mucositis prophylaxis with ice chips during oxaliplatin infusion; may recur with subsequent doses. Secondly, a more persistent (>14 days) presentation that often interferes with daily activities (eg, writing, buttoning, swallowing), these symptoms may improve in some patients upon discontinuing treatment.
• Hepatotoxicity: Hepatotoxicity (including rare cases of hepatitis and hepatic failure) has been reported. Liver biopsy has revealed peliosis, nodular regenerative hyperplasia, sinusoidal alterations, perisinusoidal fibrosis, and veno-occlusive lesions. The presence of hepatic vascular disorders (including veno-occlusive disease) should be considered, especially in individuals developing portal hypertension or who present with increased liver function tests.
• Pulmonary fibrosis: May cause pulmonary fibrosis; withhold treatment for unexplained pulmonary symptoms (eg, crackles, dyspnea, nonproductive cough, pulmonary infiltrates) until interstitial lung disease or pulmonary fibrosis are excluded.
Disease-related concerns:
• Renal impairment: Use with caution in patients with renal impairment; increased toxicity may occur.
Concurrent drug therapy issues:
• Fluorouracil (5-FU): Risk of adverse hematologic effects or adverse GI effects associated with severe diarrhea/emesis (eg, dehydration, hypokalemia, ileus) may be increased with concomitant use of 5-FU.
• Taxane derivatives: When administered as sequential infusions, taxane derivatives (docetaxel, paclitaxel) should be administered before platinum derivatives (carboplatin, cisplatin, oxaliplatin) to limit myelosuppression and enhance efficacy.
Special populations:
• Elderly: Elderly patients are more sensitive to adverse events, particularly diarrhea, dehydration, hypokalemia, leukopenia, fatigue, and syncope.
• Pediatrics: Safety and efficacy have not been established in children.
Adverse Reactions
Percentages reported with monotherapy.
>10%:
Central nervous system: Fatigue (61%), fever (25%), pain (14%), headache (13%), insomnia (11%)
Gastrointestinal: Nausea (64%), diarrhea (46%), vomiting (37%), abdominal pain (31%), constipation (31%), anorexia (20%), stomatitis (14%)
Hematologic: Anemia (64%; grades 3/4: 1%), thrombocytopenia (30%; grades 3/4: 3%), leukopenia (13%)
Hepatic: AST increased (54%; grades 3/4: 4%), ALT increased (36%; grades 3/4: 1%), total bilirubin increased (13%; grades 3/4: 5%)
Neuromuscular & skeletal: Peripheral neuropathy (may be dose limiting; 76% to 92%; acute 65%; grades 3/4: 5%; persistent 43%; grades 3/4: 3%), back pain (11%)
Respiratory: Dyspnea (13%), cough (11%)
1% to 10%:
Cardiovascular: Edema (10%), chest pain (5%), peripheral edema (5%), flushing (3%), thromboembolism (2%)
Central nervous system: Dizziness (7%)
Dermatologic: Rash (5%), alopecia (3%), hand-foot syndrome (1%)
Endocrine & metabolic: Dehydration (5%), hypokalemia (3%)
Gastrointestinal: Dyspepsia (7%), taste perversion (5%), flatulence (3%), mucositis (2%), gastroesophageal reflux (1%), dysphagia (acute 1% to 2%)
Genitourinary: Dysuria (1%)
Hematologic: Neutropenia (7%)
Local: Injection site reaction (9%; redness/swelling/pain)
Neuromuscular & skeletal: Rigors (9%), arthralgia (7%)
Ocular: Abnormal lacrimation (1%)
Renal: Serum creatinine increased (5% to 10%)
Respiratory: URI (7%), rhinitis (6%), epistaxis (2%), pharyngitis (2%), pharyngolaryngeal dysesthesia (grades 3/4: 1% to 2%)
Miscellaneous: Allergic reactions (3%); hypersensitivity (includes urticaria, pruritus, facial flushing, shortness of breath, bronchospasm, diaphoresis, hypotension, syncope: grades 3/4: 2% to 3%); hiccup (2%)
<1%, postmarketing, and/or case reports (reported with mono- and combination therapy): Acute renal failure, alkaline phosphatase increased, anaphylactic/anaphylactoid reactions, anaphylactic shock, angioedema, aphonia, ataxia, colitis, cranial nerve palsies, deep tendon reflex loss, deafness, diplopia, dysarthria, dysphonia, eosinophilic pneumonia, extravasation (including necrosis), fasciculations, gait abnormal, hematuria, hemolysis, hemolytic anemia (immuno-allergic), hemolytic uremia syndrome, hemorrhage, hepatic failure, hepatitis, hepatotoxicity, hypertension, hypomagnesemia, hypoxia, ileus, INR increased, interstitial lung diseases, interstitial nephritis (acute), intestinal obstruction, intracerebral bleeding, Lhermittes' sign, metabolic acidosis, muscle spasm, myoclonus, neutropenic fever, neutropenic sepsis, neutropenic typhlitis, nodular regenerative hyperplasia, optic neuritis, pancreatitis, peliosis, prothrombin time increased, ptosis, rectal hemorrhage, rhabdomyolysis, seizure, sepsis, thrombocytopenia (immuno-allergic), trigeminal neuralgia, tubular necrosis (acute), veno-occlusive liver disease (sinusoidal obstruction syndrome and perisinusoidal fibrosis), visual disturbance (acuity decreased, field disturbance, transient loss)
Drug Interactions
BCG: Immunosuppressants may diminish the therapeutic effect of BCG. Risk X: Avoid combination
Cardiac Glycosides: Antineoplastic Agents may decrease the absorption of Cardiac Glycosides. This may only affect digoxin tablets. Exceptions: Digitoxin. Risk C: Monitor therapy
Denosumab: May enhance the adverse/toxic effect of Immunosuppressants. Specifically, the risk for serious infections may be increased. Risk C: Monitor therapy
Echinacea: May diminish the therapeutic effect of Immunosuppressants. Risk D: Consider therapy modification
Leflunomide: Immunosuppressants may enhance the adverse/toxic effect of Leflunomide. Specifically, the risk for hematologic toxicity such as pancytopenia, agranulocytosis, and/or thrombocytopenia may be increased. Management: Consider not using a leflunomide loading dose in patients receiving other immunosuppressants. Patients receiving both leflunomide and another immunosuppressant should be monitored for bone marrow suppression at least monthly. Risk D: Consider therapy modification
Natalizumab: Immunosuppressants may enhance the adverse/toxic effect of Natalizumab. Specifically, the risk of concurrent infection may be increased. Risk X: Avoid combination
Pimecrolimus: May enhance the adverse/toxic effect of Immunosuppressants. Risk X: Avoid combination
Roflumilast: May enhance the immunosuppressive effect of Immunosuppressants. Risk X: Avoid combination
Sipuleucel-T: Immunosuppressants may diminish the therapeutic effect of Sipuleucel-T. Risk C: Monitor therapy
Tacrolimus (Topical): May enhance the adverse/toxic effect of Immunosuppressants. Risk X: Avoid combination
Taxane Derivatives: Platinum Derivatives may enhance the myelosuppressive effect of Taxane Derivatives. Administer Taxane derivative before Platinum derivative when given as sequential infusions to limit toxicity. Risk D: Consider therapy modification
Topotecan: Platinum Derivatives may enhance the adverse/toxic effect of Topotecan. Risk D: Consider therapy modification
Trastuzumab: May enhance the neutropenic effect of Immunosuppressants. Risk C: Monitor therapy
Vaccines (Inactivated): Immunosuppressants may diminish the therapeutic effect of Vaccines (Inactivated). Risk C: Monitor therapy
Vaccines (Live): Immunosuppressants may enhance the adverse/toxic effect of Vaccines (Live). Vaccinial infections may develop. Immunosuppressants may diminish the therapeutic effect of Vaccines (Live). Management: Avoid use of live organism vaccines with immunosuppressants; live-attenuated vaccines should not be given for at least 3 months after immunosuppressants. Risk X: Avoid combination
Vitamin K Antagonists (eg, warfarin): Antineoplastic Agents may enhance the anticoagulant effect of Vitamin K Antagonists. Antineoplastic Agents may diminish the anticoagulant effect of Vitamin K Antagonists. Risk C: Monitor therapy
Storage
Store intact vials at room temperature of 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F); do not freeze. Protect concentrated solution from light (store in original outer carton). According to the manufacturer, solutions diluted for infusion are stable up to 6 hours at room temperature of 20°C to 25°C (68°F to 77°F) or up to 24 hours under refrigeration at 2°C to 8°C (36°F to 46°F). Oxaliplatin solution diluted with D5W to a final concentration of 0.7 mg/mL (polyolefin container) has been shown to retain >90% of its original concentration for up to 30 days when stored at room temperature or refrigerated; artificial light did not affect the concentration (Andre, 2007). As this study did not examine sterility, refrigeration would be preferred to limit microbial growth. Solutions diluted for infusion do not require protection from light.
Reconstitution
Do not prepare using a chloride-containing solution such as NaCl due to rapid conversion to monochloroplatinum, dichloroplatinum, and diaquoplatinum; all highly reactive in sodium chloride (Takimoto, 2007). Use appropriate precautions for handling and disposal. Do not use needles or administration sets containing aluminum during preparation.
Aqueous solution: Dilution with D5W (250 or 500 mL) is required prior to administration.
Lyophilized powder [CAN; not available in U.S.]: Use only water for injection or D5W to reconstitute powder. To obtain final concentration of 5 mg/mL add 10 mL of diluent to 50 mg vial or 20 mL diluent to 100 mg vial. Gently swirl vial to dissolve powder. Dilution with D5W (250 or 500 mL) is required prior to administration. Discard unused portion of vial.
Compatibility
Incompatible with alkaline solutions (eg, fluorouracil) and chloride-containing solutions. Flush infusion line with D5W prior to, and following, administration of concomitant medications via same I.V. line.
Y-site administration: Compatible: Allopurinol, aminophylline, bumetanide, buprenorphine, butorphanol, calcium gluconate, carboplatin, chlorpromazine, cimetidine, cyclophosphamide, dexamethasone, diphenhydramine, dobutamine, docetaxel, dolasetron, dopamine, doxorubicin, droperidol, enalaprilat, epirubicin, etoposide phosphate, famotidine, fentanyl, furosemide, gemcitabine, granisetron, haloperidol lactate, heparin, hydrocortisone sodium succinate, hydromorphone, hydroxyzine, ifosfamide, irinotecan, leucovorin calcium, lorazepam, magnesium sulfate, mannitol, meperidine, mesna, methotrexate, methylprednisolone sodium succinate, metoclopramide, mitoxantrone, morphine, nalbuphine, ondansetron, paclitaxel, palonosetron, potassium chloride, prochlorperazine, promethazine, ranitidine, sodium bicarbonate, theophylline, topotecan, verapamil, vincristine, vinorelbine. Incompatible: Diazepam.
Mechanism of Action
Oxaliplatin, a platinum derivative, is an alkylating agent. Following intracellular hydrolysis, the platinum compound binds to DNA forming cross-links which inhibit DNA replication and transcription, resulting in cell death. Cytotoxicity is cell-cycle nonspecific.
Pharmacodynamics/Kinetics
Distribution: Vd: 440 L
Protein binding: >90% primarily albumin and gamma globulin (irreversible binding to platinum)
Metabolism: Nonenzymatic (rapid and extensive), forms active and inactive derivatives
Half-life elimination: Terminal: 391 hours
Excretion: Urine (~54%); feces (~2%)
Dosage
Details concerning dosing in combination regimens should also be consulted. Delay dosage in subsequent cycles until recovery of neutrophils ≥1.5 x 109/L and platelets ≥75 x 109/L. I.V.:
Adults:
Advanced colorectal cancer: 85 mg/m2 every 2 weeks until disease progression or unacceptable toxicity (in combination with fluorouracil/leucovorin)
Stage III colon cancer (adjuvant): 85 mg/m2 every 2 weeks for 12 cycles (in combination with fluorouracil/leucovorin)
Colon/colorectal cancer (unlabeled doses or combinations): 85 mg/m2/dose on days 1, 15, and 29 of an 8-week treatment cycle in combination with fluorouracil/leucovorin (Kuebler, 2007) or 85 mg/m2 every 2 weeks in combination with fluorouracil/leucovorin/irinotecan (Falcone, 2007) or 130 mg/m2 every 3 weeks in combination with capecitabine (Cassidy, 2008)
Esophageal/gastric cancers (unlabeled use; as part of a combination chemotherapy regimen): 85 mg/m2 every 2 weeks (Al-Batran, 2008) or 130 mg/m2 every 3 weeks (Cunningham, 2008)
or
Gastric cancer: 100 mg/m2 every 2 weeks (Louvet, 2002)
Hepatobiliary cancer (unlabeled use; as part of a combination chemotherapy regimen): 100 mg/m2 every 2 weeks (Andre, 2004) or 130 mg/m2 every 3 weeks (Nehls, 2008)
Non-Hodgkin's lymphoma (unlabeled use; as part of a combination chemotherapy regimen): 25 mg/m2/day for 4 days every 4 weeks (Tsimberidou, 2008) or 100 mg/m2 every 3 weeks (Lopez, 2008; Rodriguez, 2007) or 130 mg/m2 every 3 weeks (Chau, 2001)
Ovarian cancer (unlabeled use): 130 mg/m2 every 3 weeks (Dieras, 2002; Piccart, 2000)
Pancreatic cancer (unlabeled use; as part of a combination chemotherapy regimen): 85 mg/m2 every 2 weeks (Conroy, 2005) or 100 mg/m2 every 2 weeks (Louvet, 2005) or 110-130 mg/m2 every 3 weeks (Xiong, 2008)
Testicular cancer (unlabeled use; in combination with gemcitabine): 130 mg/m2 every 3 weeks (Kollmannsberger, 2004; Pectasides, 2004)
Elderly: No dosing adjustment recommended
Dosage adjustments for toxicity: Acute toxicities: Longer infusion times (up to 6 hours) may mitigate acute toxicities.
Neurosensory events:
Persistent (>7 days) grade 2 neurosensory events: Consider oxaliplatin dose reduction if symptoms do not resolve:
Adjuvant treatment of stage III colon cancer: Reduce dose to 75 mg/m2
Advanced colorectal cancer: Reduce dose to 65 mg/m2
Consider withholding oxaliplatin for grade 2 neuropathy lasting >7 days despite dose reduction.
Persistent grade 3 neurosensory events: Consider discontinuing oxaliplatin
Other toxicities (grade 3/4 gastrointestinal toxicity, grade 4 neutropenia, or grade 3/4 thrombocytopenia): After recovery from toxicity, oxaliplatin dose reductions are recommended:
Adjuvant treatment of stage III colon cancer: Reduce dose to 75 mg/m2 ; delay next dose until neutrophils recover to ≥1500/mm3 and platelets recover to ≥75,000/mm3
Advanced colorectal cancer: Reduce dose to 65 mg/m2; delay next dose until neutrophils recover to ≥1500/mm3 and platelets recover to ≥75,000/mm3
Dosage adjustment in renal impairment: The FDA-approved labeling does not contain renal dosing adjustment guidelines. Oxaliplatin is primarily eliminated renally; in patients with Clcr <30 mL/minute, the AUC is increased ~190%. Oxaliplatin use has been studied in 25 patients with renal dysfunction; treatment was well-tolerated in patients with mild-to-moderate impairment (Clcr 20-59 mL/minute), suggesting that dose reduction is not necessary in this patient population (Takimoto, 2003). Patients with severe renal impairment (Clcr <20 mL/minute) have not been adequately studied; consider omitting dose or changing chemotherapy regimen if Clcr <20 mL/minute.
Note: Canadian labeling: Use in patients with Clcr <30 mL/minute is contraindicated in Canadian labeling.
Dosage adjustment in hepatic impairment: Mild, moderate, or severe hepatic impairment: Dosage adjustment not necessary (Doroshow, 2003; Synold, 2007)
Dosage: Combination Regimens
Biliary adenocarcinoma: GEMOX (Biliary Cancer)
Colorectal cancer:
Bevacizumab-Oxaliplatin-Fluorouracil-Leucovorin
CAPOX (Colorectal Cancer)
Cetuximab-FOLFOX4
FLOX (Nordic FLOX)
FOLFOX 1
FOLFOX 2
FOLFOX 3
FOLFOX 4
FOLFOX 6
FOLFOX 7
FOLFOXIRI (Colorectal Cancer)
Esophageal cancer:
Docetaxel-Oxaliplatin-Fluorouracil (Esophageal Cancer)
Docetaxel-Oxaliplatin-Leucovorin-Fluorouracil (Esophageal Cancer)
Epirubicin-Oxaliplatin-Capecitabine
Epirubicin-Oxaliplatin-Fluorouracil (Esophageal Cancer)
Fluorouracil-Leucovorin-Oxaliplatin (Esophageal Cancer)
Oxaliplatin-Fluorouracil (Esophageal Cancer)
Gastric cancer:
Epirubicin-Oxaliplatin-Capecitabine
Fluorouracil-Leucovorin-Oxaliplatin (Gastric Cancer)
Gastrointestinal cancer: CAPOX (Biliary Cancer)
Leukemia, chronic lymphocytic: OFAR (CLL)
Lymphoma, non-Hodgkin's:
Gemcitabine-Oxaliplatin-Rituximab (NHL)
Oxaliplatin-Cytarabine-Dexamethasone (NHL Regimen)
Ovarian cancer: Docetaxel-Oxaliplatin (Ovarian Cancer)
Pancreatic cancer:
CAPOX (Pancreatic Cancer)
FOLFIRINOX (Pancreatic Cancer)
Gemcitabine-Oxaliplatin (Pancreatic Cancer)
Testicular cancer: GEMOX (Testicular Cancer)
Administration: I.V.
Administer as I.V. infusion over 2-6 hours. Flush infusion line with D5W prior to administration of any concomitant medication. Patients should receive an antiemetic premedication regimen. Avoid mucositis prophylaxis with ice chips during oxaliplatin infusion (may exacerbate acute neurological symptoms).
Monitoring Parameters
CBC with differential, blood chemistries (including serum creatinine, ALT, AST, and bilirubin); INR and prothrombin time (in patients on oral anticoagulant therapy); signs of neuropathy, hypersensitivity, and/or respiratory effects
Patient Education
This medication can only be administered by infusion; you will be monitored closely during and following infusion. Report immediately any pain, burning, or swelling at infusion site or any signs of allergic reaction (eg, respiratory difficulty, difficulty swallowing, back pain, chest tightness, rash, hives, swelling of lips or mouth). It is important that you maintain adequate nutrition and hydration, unless instructed to restrict fluid intake. You may be more susceptible to infection. You may experience temporary numbness, pain, tingling, or loss of sensation in hands, feet, or throat (cold will exacerbate these effects; remain warm, cover skin before exposure to cold, and avoid cold drinks or the use of ice); if this condition persists or is severe contact prescriber. May cause fatigue, headache, insomnia, nausea, vomiting, loss of appetite, taste perversion, mouth sores, diarrhea, constipation, or loss of hair (reversible). Report chest pain or palpitations; swelling, pain, or hot areas in legs; unusual fatigue; unusual bruising or bleeding; cough, sore throat, or respiratory difficulty; or muscle cramps or twitching.
Additional Information
Cold temperature may exacerbate acute neuropathy. Do not use ice for mucositis prophylaxis.
Dental Health: Effects on Dental Treatment
Key adverse event(s) related to dental treatment: Stomatitis, dysphagia, mucositis, and taste perversion.
Dental Health: Vasoconstrictor/Local Anesthetic Precautions
No information available to require special precautions
Mental Health: Effects on Mental Status
Fatigue is common; may cause insomnia and dizziness
Mental Health: Effects on Psychiatric Treatment
GI side effects are common; use caution with SSRIs. Hematologic side effects are common; use caution with clozapine, carbamazepine, and valproic acid
Nursing: Physical Assessment/Monitoring
Assess for use-related cautions prior to beginning therapy. Patient must be observed closely for anaphylactic-like reactions (can occur within minutes of administration; appropriate medications for the treatment of hypersensitivity reactions should be available). Monitor for pulmonary or hepatic toxicity, neuropathy (acute or persistent), GI disturbance, anemia, chest pain, and thromboembolism during and between each infusion.
Oncology: Emetic Potential
Moderate (30% to 90%)
Oncology: Vesicant
Vesicant; see Management of Drug Extravasations.
Cool compress may be used for immediate management of extravasation, with consideration of potential for peripheral neuropathy exacerbated by cold. Warm compresses will avoid peripheral neuropathy, however, while possibly increasing drug removal through local vasodilation, may increase cellular uptake and injury.
Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Injection, powder for reconstitution: 50 mg, 100 mg
Injection, solution: 5 mg/mL (10 mL, 20 mL)
Injection, solution [preservative free]:
Eloxatin®: 5 mg/mL (10 mL, 20 mL, 40 mL)
Injection, solution [concentrate, preservative free]: 5 mg/mL (10 mL [DSC], 20 mL [DSC])
References
Al-Batran SE, Hartmann JT, Probst S, et al, “Phase III Trial in Metastatic Gastroesophageal Adenocarcinoma With Fluorouracil, Leucovorin Plus Either Oxaliplatin or Cisplatin: A Study of the Arbeitsgemeinschaft Internistische Onkologie,” J Clin Oncol, 2008, 26(9):1435-42.
Andre P, Cisternino S, Roy AL, et al, “Stability of Oxaliplatin in Infusion Bags Containing 5% Dextrose Injection,” Am J Health Syst Pharm, 2007, 64(18):1950-4.
Andre T, Boni C, Mounedji-Boudiaf L, et al, “Oxaliplatin, Fluorouracil, and Leucovorin as Adjuvant Treatment for Colon Cancer,” N Engl J Med, 2004, 350(23):2343-51.
Andre T, Boni C, Navarro M, et al, “Improved Overall Survival With Oxaliplatin, Fluorouracil, and Leucovorin as Adjuvant Treatment in Stage II or III Colon Cancer in the MOSAIC Trial,” J Clin Oncol, 2009, 27(19):3109-16.
Andre T, Tournigand C, Rosmorduc O, et al, “Gemcitabine Combined With Oxaliplatin (GEMOX) in Advanced Biliary Tract Adenocarcinoma: A GERCOR Study,” Ann Oncol, 2004, 15(9):1339-43.
Bertheault-Cvitkovic F, Jami A, Ithzaki M, et al, “Biweekly Intensified Ambulatory Chronomodulated Chemotherapy With Oxaliplatin, Fluorouracil, and Leucovorin in Patients With Metastatic Colorectal Cancer,” J Clin Oncol, 1996, 14(11):2950-8.
Cassidy J and Misset JL, “Oxaliplatin-Related Side Effects: Characteristics and Management,” Semin Oncol, 2002, 29(5 Suppl 15):11-20.
Cassidy J, Clarke S, Díaz-Rubio E, et al, “Randomized Phase III Study of Capecitabine Plus Oxaliplatin Compared With Fluorouracil/Folinic Acid Plus Oxaliplatin as First-Line Therapy for Metastatic Colorectal Cancer,” J Clin Oncol, 2008, 26(12):2006-12.
Cersosimo RJ, “Oxaliplatin-Associated Neuropathy: A Review,” Ann Pharmacother, 2005, 39(1):128-35.
Chau I, Webb A, Cunningham D, et al, “An Oxaliplatin-Based Chemotherapy in Patients With Relapsed or Refractory Intermediate and High-Grade Non-Hodgkin's Lymphoma,” Br J Haematol, 2001, 115(4):786-92.
Conroy T, Paillot B, François E, et al, “Irinotecan Plus Oxaliplatin and Leucovorin-Modulated Fluorouracil in Advanced Pancreatic Cancer -- A Groupe Tumeurs Digestives of the Federation Nationale des Centres de Lutte Contre le Cancer Study,” J Clin Oncol, 2005, 23(6):1228-36.
Cunningham D, Starling N, Rao S, et al, “Capecitabine and Oxaliplatin for Advanced Esophagogastric Cancer,” N Engl J Med, 2008, 358(1):36-46.
de Lemos ML and Walisser S, “Management of Extravasation of Oxaliplatin,”J Oncol Pharm Pract, 2005, 11(4):159-62.
Dieras V, Bougnoux P, Petit T, et al, “Multicentre Phase II Study of Oxaliplatin as a Single-Agent in Cisplatin/Carboplatin +/- Taxane-Pretreated Ovarian Cancer Patients,” Ann Oncol, 2002, 13(2):258-66.
Doroshow JH, Synold TW, Gandara D, et al, “Pharmacology of Oxaliplatin in Solid Tumor Patients With Hepatic Dysfunction: A Preliminary Report of the National Cancer Institute Organ Dysfunction Working Group,” Semin Oncol, 2003, 30(4 Suppl 15):14-9.
Falcone A, Ricci S, Brunetti I, et al, “Phase III Trial of Infusional Fluorouracil, Leucovorin, Oxaliplatin, and Irinotecan (FOLFOXIRI) Compared With Infusional Fluorouracil, Leucovorin, and Irinotecan (FOLFIRI) as First-Line Treatment for Metastatic Colorectal Cancer: The Gruppo Oncologico Nord Ovest,” J Clin Oncol, 2007, 25(13):1670-6.
Graham MA, Lockwood GF, Greenslade D, et al, “Clinical Pharmacokinetics of Oxaliplatin: A Critical Review,” Clin Cancer Res, 2000, 6(4):1205-18.
Khushalani NI, Leichman CG, Proulx G, et al, “Oxaliplatin in Combination with Protracted-Infusion Fluorouracil and Radiation: Report of a Clinical Trial for Patients With Esophageal Cancer,” J Clin Oncol, 2002, 20(12):2844-50.
Kollmannsberger C, Beyer J, Liersch R, et al, “Combination Chemotherapy With Gemcitabine Plus Oxaliplatin in Patients With Intensively Pretreated or Refractory Germ Cell Cancer: A Study of the German Testicular Cancer Study Group,” J Clin Oncol, 2004, 22(1):108-14.
KueblerJP, Wieand HS, O'Connell MJ, et al, “Oxaliplatin Combined With Weekly Bolus Fluorouracil and Leucovorin as Surgical Adjuvant Chemotherapy for Stage II and III Colon Cancer: Results From NSABP C-07,” J Clin Oncol, 2007, 25(16):2198-204.
Levi F, Metzger G, Massari C, et al, “Oxaliplatin: Pharmacokinetics and Chronopharmacological Aspects,” Clin Pharmacokinet, 2000, 38(1):1-21.
López A, Gutiérrez A, Palacios A, et al, “GEMOX-R Regimen is a Highly Effective Salvage Regimen in Patients With Refractory/Relapsing Diffuse Large-Cell Lymphoma: A Phase II Study,” Eur J Haematol, 2008, 80(2):127-32.
Louvet C, André T, Tigaud JM, et al, “Phase II Study of Oxaliplatin, Fluorouracil, and Folinic Acid in Locally Advanced or Metastatic Gastric Cancer Patients,” J Clin Oncol, 2002, 20(23):4543-8.
Louvet C, Labianca R, Hammel P, et al, “Gemcitabine in Combination With Oxaliplatin Compared With Gemcitabine Alone in Locally Advanced or Metastatic Pancreatic Cancer: Results of a GERCOR and GISCAD Phase III Trial,” J Clin Oncol, 2005, 23(15):3509-16.
Morgan C, Tillett T, Braybrooke J, et al, “Management of Uncommon Chemotherapy-Induced Emergencies,” Lancet Oncol, 2011 [epub ahead of print].
Nehls O, Oettle H, Hartmann JT, et al, “Capecitabine Plus Oxaliplatin as First-Line Treatment in Patients With Advanced Biliary System Adenocarcinoma: A Prospective Multicentre Phase II Trial,” Br J Cancer, 2008, 98(2):309-15.
Pectasides D, Pectasides M, Farmakis D, et al, “Gemcitabine and Oxaliplatin (GEMOX) in Patients With Cisplatin-Refractory Germ Cell Tumors: A Phase II Study,” Ann Oncol, 2004, 15(3):493-7.
Piccart MJ, Green JA, Lacave AJ, et al, “Oxaliplatin or Paclitaxel in Patients With Platinum-Pretreated Advanced Ovarian Cancer: A Randomized Phase II Study of the European Organization for Research and Treatment of Cancer Gynecology Group,” J Clin Oncol, 2000, 18(6):1193-202.
Rodríguez J, Gutierrez A, Palacios A, et al, “Rituximab, Gemcitabine and Oxaliplatin: An Effective Regimen in Patients With Refractory and Relapsing Mantle Cell Lymphoma,” Leuk Lymphoma, 2007, 48(11):2172-8.
Synold TW, Takimoto CH, Doroshow JH, et al, “Dose-Escalating and Pharmacologic Study of Oxaliplatin in Adult Cancer Patients With Impaired Hepatic Function: A National Cancer Institute Organ Dysfunction Working Group Study,” Clin Cancer Res, 2007, 13(12):3660-6.
Takimoto CH, Graham MA, Lockwood G, et al, “Oxaliplatin Pharmacokinetics and Pharmacodynamics in Adult Cancer patients With Impaired Renal Function,” Clin Cancer Res, 2007, 13(16):4832-9.
Takimoto CH, Remick SC, Sharma S, et al, “Dose-Escalating and Pharmacological Study of Oxaliplatin in Adult Cancer Patients With Impaired Renal Function: A National Cancer Institute Organ Dysfunction Working Group Study,” J Clin Oncol, 2003, 21(14):2664-72.
Trissel LA, Saenz CA, Ingram DS, et al, “Compatibility Screening of Oxaliplatin During Simulated Y-Site Administration With Other Drugs,” J Oncol Pharm Practice, 2002, 8(1):33-7.
Tsimberidou AM, Wierda WG, Plunkett W, et al, “Phase I-II Study of Oxaliplatin, Fludarabine, Cytarabine, and Rituximab Combination Therapy in Patients With Richter's Syndrome or Fludarabine-Refractory Chronic Lymphocytic Leukemia,” J Clin Oncol, 2008, 26(2):196-203.
Wiseman LR, Adkins JC, Plosker GL, et al, “Oxaliplatin: A Review of Its Use in the Management of Metastatic Colorectal Cancer,” Drugs Aging, 1999, 14(6):459-75.
Xiong HQ, Varadhachary GR, Blais JC, et al, “Phase 2 Trial of Oxaliplatin Plus Capecitabine (XELOX) as Second-Line Therapy for Patients With Advanced Pancreatic Cancer,” Cancer, 2008, 113(8):2046-52.
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