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Sponsors and Collaborators: |
North Central Cancer Treatment Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00255762 |
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. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving carboplatin and paclitaxel together with bevacizumab may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving carboplatin and paclitaxel together with bevacizumab works in treating patients with stage IV melanoma that cannot be removed by surgery.
Condition | Intervention | Phase |
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Melanoma (Skin) |
Biological: bevacizumab Drug: carboplatin Drug: paclitaxel |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Trial of Carboplatin, Weekly Paclitaxel and Biweekly Bevacizumab in Patients With Unresectable Stage IV Melanoma |
Estimated Enrollment: | 47 |
Study Start Date: | December 2005 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive carboplatin IV over 30 minutes on day 1, paclitaxel IV over 1 hour on days 1, 8, and 15, and bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for up to 5 years.
PROJECTED ACCRUAL: A total of 47 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 confirmed melanoma
Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR
PATIENT CHARACTERISTICS:
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Gastrointestinal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
No prior antivascular endothelial growth factors (VEGF), including any of the following:
Chemotherapy
Radiotherapy
Surgery
Other
No concurrent full-dose oral or parenteral anticoagulation
Study Chair: | Svetomir Markovic, MD, PhD | Mayo Clinic |
Investigator: | Daniel Nikcevich, MD, PhD | Duluth Clinic Cancer Center - Duluth |
Investigator: | Edward T. Creagan, MD | Mayo Clinic |
Investigator: | Lori A. Erickson, MD | Mayo Clinic |
Investigator: | Judith S. Kaur, MD | Mayo Clinic |
Study ID Numbers: | CDR0000449967, NCCTG-N047A |
Study First Received: | November 18, 2005 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00255762 History of Changes |
Health Authority: | United States: Food and Drug Administration |
recurrent melanoma stage IV melanoma |
Bevacizumab Carboplatin Antimitotic Agents Angiogenesis Inhibitors Recurrence Melanoma Neuroendocrine Tumors Neuroectodermal Tumors |
Paclitaxel Neoplasms, Germ Cell and Embryonal Nevus, Pigmented Tubulin Modulators Neuroepithelioma Nevus Antineoplastic Agents, Phytogenic |
Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances Physiological Effects of Drugs Mitosis Modulators Neoplasms, Nerve Tissue Antimitotic Agents Bevacizumab Carboplatin Angiogenesis Inhibitors Pharmacologic Actions |
Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms Paclitaxel Neoplasms, Germ Cell and Embryonal Therapeutic Uses Tubulin Modulators Nevi and Melanomas Growth Inhibitors Angiogenesis Modulating Agents Antineoplastic Agents, Phytogenic |