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Sponsors and Collaborators: |
Southwest Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00329641 |
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 help carboplatin and paclitaxel work better by making tumor cells more sensitive to the drugs. Sorafenib may also stop the growth of melanoma by blocking some of the enzymes needed for tumor cell growth and by blocking blood flow to the tumor. Giving sorafenib together with carboplatin and paclitaxel may kill more tumor cells.
PURPOSE: This phase II trial is studying how well sorafenib works when given together with carboplatin and paclitaxel in treating patients with stage IV melanoma of the eye.
Condition | Intervention | Phase |
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Intraocular Melanoma |
Drug: carboplatin Drug: paclitaxel Drug: sorafenib tosylate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label |
Official Title: | Phase II Trial of BAY 43-9006 (SORAFENIB; NSC-724772) in Combination With Carboplatin and Paclitaxel in Patients With Metastatic Uveal Melanoma |
Estimated Enrollment: | 40 |
Study Start Date: | March 2006 |
Estimated Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a nonrandomized, open-label, multicenter study.
Patients receive carboplatin IV and paclitaxel IV once on day 1 and oral sorafenib twice daily on days 2-19.
Treatment repeats every 21 days for up to 6 courses.* After 6 courses, patients continue to receive oral sorafenib alone twice daily in the absence of disease progression or unacceptable toxicity.
NOTE: *If sorafenib is discontinued prior to course 6, patients may continue to receive carboplatin and paclitaxel for up to 6 courses; if carboplatin and paclitaxel are discontinued prior to course 6, patients may continue to receive sorafenib alone twice daily on days 1-21 of each course in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for up to 3 years.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically proven uveal melanoma
Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
At least 28 days since prior systemic treatment for this disease comprising 1 of the following:
No concurrent systemic corticosteroid therapy
Concurrent full-dose oral anticoagulants (e.g., warfarin) are allowed provided all of the following criteria are met:
Study Chair: | Ana Aparicio, MD | M.D. Anderson Cancer Center |
Investigator: | Jeffrey S. Weber, MD, PhD | H. Lee Moffitt Cancer Center and Research Institute |
Responsible Party: | Southwest Oncology Group - Group Chair's Office ( Laurence H. Baker ) |
Study ID Numbers: | CDR0000467188, SWOG-S0512 |
Study First Received: | May 23, 2006 |
Last Updated: | April 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00329641 History of Changes |
Health Authority: | United States: Food and Drug Administration |
ciliary body and choroid melanoma, medium/large size iris melanoma recurrent intraocular melanoma extraocular extension melanoma metastatic intraocular melanoma |
Eye Neoplasms Uveal Melanoma Eye Diseases Melanoma of the Choroid Antimitotic Agents Carboplatin Protein Kinase Inhibitors Recurrence Melanoma Neuroendocrine Tumors Ocular Melanoma |
Neuroectodermal Tumors Paclitaxel Neoplasms, Germ Cell and Embryonal Nevus, Pigmented Tubulin Modulators Intraocular Melanoma Neuroepithelioma Nevus Antineoplastic Agents, Phytogenic Sorafenib |
Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Eye Neoplasms Antineoplastic Agents Eye Diseases Mitosis Modulators Neoplasms, Nerve Tissue Enzyme Inhibitors Antimitotic Agents Carboplatin Protein Kinase Inhibitors Pharmacologic Actions |
Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms Neoplasms by Site Paclitaxel Therapeutic Uses Neoplasms, Germ Cell and Embryonal Tubulin Modulators Nevi and Melanomas Antineoplastic Agents, Phytogenic Sorafenib |