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Sponsors and Collaborators: |
Northern California Melanoma Center Abraxis BioScience Inc. Genentech |
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Information provided by: | Northern California Melanoma Center |
ClinicalTrials.gov Identifier: | NCT00462423 |
The study is an open-label, single arm multicenter Phase II study to evaluate the safety and efficacy of the combination of Abraxane and Avastin as first-line therapy for patients with unresectable metastatic malignant melanoma. The patient sample will be approximately 50 individuals, males and females 18 years of age or older with measurable metastatic melanoma.
Patients will be treated with Abraxane administered weekly for 3 weeks via a 30-minute IV infusion at150 mg/m2 followed by 1 week rest (28-day cycle). Avastin will be administered in a dose of 10 mg/kg every 2 weeks (without rest period). Patients will be evaluated for disease progression every 2 months and those who do not have disease progression or unacceptable toxicity will be offered ongoing therapy until they have progressive disease or unacceptable toxicity.
Condition | Intervention | Phase |
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Metastatic Malignant Melanoma |
Drug: Nanoparticle albumin-bound paclitaxel (Abraxane) Drug: Bevacizumab (Avastin) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Abraxane and Avastin as Therapy for Patients With Malignant Melanoma, a Phase II Study |
Estimated Enrollment: | 50 |
Study Start Date: | April 2007 |
Estimated Study Completion Date: | April 2009 |
It has been suggested that chemotherapy administration may be synergistic with the effects of an antiangiogenic agent such as Avastin. A “Proof of Principal” of the concept of the synergistic effects of chemotherapy and antiangiogenic therapy has been shown in the favorable results reported with temozolomide administered in combination with thalidomide in melanoma, the favorable results reported for the use of FOLFOX4 in combination with Avastin in previously treated patients with advanced or metastatic colorectal cancer, and the approval of the combination of Avastin with 5-fluorouracil-based chemotherapy in the treatment of patients with metastatic carcinoma of the colon or rectum.
A number of lines of evidence suggest that the combination of Abraxane and Avastin may be effective as first-line therapy for melanoma:
Taxanes are active agents in melanoma:
The primary end-point of the study is progression-free survival (PFS) at 4 months. Secondary end-points include progression-free survival, overall survival (OS), objective Response Rate (RR) in patients with measurable lesions, time to objective response, duration of objective response in patients with measurable lesions, and safety and tolerability of this combination.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Lynn E. Spitler, MD | 415-435-9861 | ls@drspitler.com |
Contact: Lori A. Richards, RN | 510-450-1646 | loriannrichards@sbcglobal.net |
United States, California | |
Northern California Melanoma Center | Recruiting |
San Francisco, California, United States, 94109 | |
Contact: Lynn E. Spitler, MD 415-435-9861 ls@drspitler.com | |
Contact: Sharon Trautvetter, RN 415-353-6535 Sharon.Trautvetter@chw.edu | |
Principal Investigator: Lynn E Spitler, MD | |
Sub-Investigator: Robert Weber, MD |
Principal Investigator: | Lynn E. Spitler, MD | Northern California Melanoma Center |
Study ID Numbers: | 070223 |
Study First Received: | April 18, 2007 |
Last Updated: | April 18, 2007 |
ClinicalTrials.gov Identifier: | NCT00462423 |
Health Authority: | United States: Institutional Review Board |
Metastatic malignant melanoma First-line therapy |
Neuroectodermal Tumors Paclitaxel Nevus, Pigmented Neoplasms, Germ Cell and Embryonal Neuroepithelioma |
Bevacizumab Nevus Neuroendocrine Tumors Melanoma |
Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances Physiological Effects of Drugs Neoplasms, Nerve Tissue Mitosis Modulators Antimitotic Agents Angiogenesis Inhibitors |
Pharmacologic Actions Neoplasms Therapeutic Uses Tubulin Modulators Nevi and Melanomas Growth Inhibitors Angiogenesis Modulating Agents Antineoplastic Agents, Phytogenic |