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Sponsors and Collaborators: |
Eastern Cooperative Oncology Group National Cancer Institute (NCI) Southwest Oncology Group |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00110019 |
RATIONALE: 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 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 is more effective than carboplatin and paclitaxel in treating melanoma.
PURPOSE: This randomized phase III trial is studying carboplatin, paclitaxel, and sorafenib to see how well they work compared to carboplatin and paclitaxel in treating patients with unresectable stage III or stage IV melanoma.
Condition | Intervention | Phase |
---|---|---|
Melanoma (Skin) |
Drug: carboplatin Drug: paclitaxel Drug: sorafenib tosylate Other: placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control |
Official Title: | A Double-Blind, Randomized, Placebo-Controlled Phase III Trial of Carboplatin, Paclitaxel, and BAY 43-9006 Versus Carboplatin, Paclitaxel, and Placebo in Patients With Unresectable Stage III or IV Melanoma |
Estimated Enrollment: | 800 |
Study Start Date: | June 2005 |
Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Arm I: Experimental
Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Patients also receive oral sorafenib twice daily on days 2-19.
|
Drug: carboplatin
Given IV
Drug: paclitaxel
Given IV
Drug: sorafenib tosylate
Given orally
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Arm II: Active Comparator
Patients receive paclitaxel and carboplatin as in arm I. Patients also receive oral placebo twice daily on days 2-19.
|
Drug: carboplatin
Given IV
Drug: paclitaxel
Given IV
Other: placebo
Given orally
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OBJECTIVES:
Primary
Secondary
Tertiary
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to prior therapy in the adjuvant or metastatic setting (no prior therapy vs prior therapy with interferon, interleukin-2, or sargramostim [GM-CSF] vs 1 prior investigational therapy that is not chemotherapy or an inhibitor of Ras, Raf, or MEK), disease stage (unresectable stage III vs M1a or M1b vs M1c), or ECOG performance status (0 vs 1).
Patients are randomized to 1 of 2 treatment arms.
In both arms, treatment repeats every 21 days for 10 courses in the absence of disease progression or unacceptable toxicity. Patients with stable disease or who achieve a partial response or complete response may continue to receive sorafenib or placebo alone twice daily on days 1-21. Courses with sorafenib or placebo repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 800 patients will be accrued for this study within 40 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed melanoma meeting 1 of the following stage criteria:
Must have 1 of the following melanoma types:
Measurable disease
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
No prior systemic cytotoxic chemotherapy for the treatment of melanoma in the adjuvant or metastatic setting
Endocrine therapy
Radiotherapy
Surgery
Other
No more than 1 prior investigational therapy in the adjuvant or metastatic setting
Study Chair: | Keith T. Flaherty, MD | University of Pennsylvania |
Investigator: | Lynn Mara Schuchter, MD | University of Pennsylvania |
Investigator: | Lawrence E. Flaherty, MD | Barbara Ann Karmanos Cancer Institute |
Responsible Party: | ECOG Group Chair's Office ( Robert L. Comis ) |
Study ID Numbers: | CDR0000423315, ECOG-E2603 |
Study First Received: | May 3, 2005 |
Last Updated: | April 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00110019 History of Changes |
Health Authority: | United States: Food and Drug Administration |
stage III melanoma stage IV melanoma recurrent melanoma |
Carboplatin Antimitotic Agents Protein Kinase Inhibitors Recurrence Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Paclitaxel |
Neoplasms, Germ Cell and Embryonal Nevus, Pigmented Tubulin Modulators Neuroepithelioma Nevus Antineoplastic Agents, Phytogenic Sorafenib |
Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Mitosis Modulators Neoplasms, Nerve Tissue Enzyme Inhibitors Antimitotic Agents Carboplatin Protein Kinase Inhibitors Pharmacologic Actions Melanoma |
Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms Paclitaxel Neoplasms, Germ Cell and Embryonal Therapeutic Uses Tubulin Modulators Nevi and Melanomas Antineoplastic Agents, Phytogenic Sorafenib |