Carboplatin and Paclitaxel With or Without Sorafenib Tosylate in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed by Surgery

Completed · Phase 3 · Has a placebo group

Conditions studied: Mucosal Melanoma, Recurrent Melanoma, Stage IIIA Skin Melanoma, Stage IIIB Skin Melanoma, Stage IIIC Skin Melanoma, Stage IV Skin Melanoma

In brief

This randomized phase III trial studies carboplatin, paclitaxel, and sorafenib tosylate to see how well they work compared to carboplatin and paclitaxel in treating patients with stage III or stage IV melanoma that cannot be removed by surgery. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether giving carboplatin and paclitaxel together with sorafenib tosylate is more effective than carboplatin and paclitaxel in treating melanoma.

Key facts

Study ID

NCT00110019

Run by

National Cancer Institute (NCI)

People needed

823

Starts

2005-06-01

Expected to finish

2012-08-01

Last updated by the study team

2015-10-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histological or cytological confirmed melanoma that is metastatic or unresectable; patients must have a history of cutaneous, mucosal or unknown primary site
• Patients who have received prior systemic cytotoxic chemotherapy for treatment of melanoma are ineligible; the following groups are eligible with regard to prior systemic therapy either in the adjuvant or metastatic disease setting:
• No prior therapy
• Immunotherapy consisting of interferon, interleukin-2, granulocyte macrophage colony-stimulating factor (GM-CSF) or vaccine
• One prior investigational therapy (cannot be chemotherapy or an inhibitor of rat sarcoma [Ras], serine/threonine kinase [Raf], or mitogen-activated protein kinase kinase [MEK])
• NOTE: Chemotherapy given via isolated limb perfusion is allowed
• Prior radiation therapy is allowed; however, if radiation has been administered to a lesion, there must be radiographic evidence of progression of that lesion in order for that lesion to constitute measurable disease or to be included in the measured target lesions
• All sites of disease must be evaluated within 4 weeks of registration; patients must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST)
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• White blood count >= 3,000/mm\^3
• Absolute granulocyte count >= 1,500/mm\^3
• Platelet count >= 100,000/mm\^3
• Serum creatinine =< 2.0 x upper limit of normal (ULN) or serum creatinine clearance (CrCl) >= 40 ml/min (neither drug is cleared by the kidney)
• Total bilirubin =< 1.5 x ULN (< 3.0 x ULN in the presence of Gilbert's disease)
• Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2.5 x ULN (=< 5.0 ULN in the presence of liver metastases)
• International normalized ratio (INR) =< 1.5 and a partial thromboplastin time (PTT) within normal limits (patients who are on therapeutic anticoagulation with warfarin should have documentation of a normal prothrombin time [PT]/PTT prior to initiating that therapy)
• Patients must not have ocular melanoma
• Patients must have discontinued immunotherapy or radiation therapy at least 4 weeks prior to initiation of treatment and recovered from adverse events due to those agents
• Patients must not receive any other investigational agents during the period on study or the four weeks prior to initiation of treatment
• Patients must not have a history or clinical evidence of brain metastasis; patients must be evaluated with a head magnetic resonance imaging (MRI) within 4 weeks prior to enrollment
• Patients must not have other current malignancies, other than basal cell skin cancer, squamous cell skin cancer, in situ cervical cancer, ductal or lobular carcinoma in situ of the breast; patients with other malignancies are eligible if they have been continuously disease-free for >= 5 years prior to the time of randomization
• Patients must not have any evidence of bleeding diathesis
• Patients must not have a serious intercurrent illness including, but not limited to, ongoing or active infection requiring parenteral antibiotics, clinically significant cardiovascular disease (e.g. uncontrolled hypertension, myocardial infarction, unstable angina), New York Heart Association grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication, or grade II or greater peripheral vascular disease within 1 year prior to study entry, or psychiatric illness/social situations that would limit compliance with study requirements
• Patients must not be taking cytochrome P450 enzyme-inducing antiepileptic drugs (phenytoin, carbamazepine or phenobarbital), rifampin or St. John's Wort
• Women must not be pregnant or breast-feeding

Where it is running

• Mercy Hospital Fort Smith — Fort Smith, Arkansas, United States
• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• Providence Saint Joseph Medical Center/Disney Family Cancer Center — Burbank, California, United States
• City of Hope Comprehensive Cancer Center — Duarte, California, United States
• Marin Cancer Care Inc — Greenbrae, California, United States
• UC San Diego Moores Cancer Center — La Jolla, California, United States
• USC / Norris Comprehensive Cancer Center — Los Angeles, California, United States
• Bay Area Tumor Institute — Oakland, California, United States
• Saint Joseph Hospital - Orange — Orange, California, United States
• Stanford Cancer Institute — Palo Alto, California, United States
• Kaiser Permanente-Redwood City — Redwood City, California, United States
• Kaiser Permanente-Richmond — Richmond, California, United States
• Kaiser Permanente-Roseville — Roseville, California, United States
• Kaiser Permanente - Sacramento — Sacramento, California, United States
• Kaiser Permanente-San Diego Mission — San Diego, California, United States
• Veterans Administration-San Diego Medical Center — San Diego, California, United States
• Kaiser Permanente-San Francisco — San Francisco, California, United States
• California Pacific Medical Center-Pacific Campus — San Francisco, California, United States
• Kaiser Permanente-Santa Teresa-San Jose — San Jose, California, United States
• Santa Rosa Memorial Hospital — Sana Rosa, California, United States
• Kaiser Permanente Medical Center - Santa Clara — Santa Clara, California, United States
• Kaiser Permanente-Santa Rosa — Santa Rosa, California, United States
• Kaiser Permanente-Vallejo — Vallejo, California, United States
• The Medical Center of Aurora — Aurora, Colorado, United States
• University of Alabama at Birmingham Cancer Center — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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