Docetaxel and Vinorelbine Plus Sargramostim in Metastatic Malignant Melanoma
Annually in the U.S. there is an estimated 40,000 new cases of malignant melanoma and 7000 deaths. This disease is becoming more common with its incidence increasing at a more rapid rate in the past decade than that of any other cancer except lung cancer in women. Metastatic disease responds poorly to the usual treatments with only 2 out of 30 drugs tested, DTIC and nitrosoureas, showing response rates greater than 10%. Complete responses are rare.
Metastatic melanoma is a disease with few therapeutic options. Multi-agent chemotherapy with cisplatin (CDDP), Dacarbazine (DTIC), Carmustine (BCNU), with or without Tamoxifen, offers a 20% response rate but has failed to consistently demonstrate a significant improvement in overall survival (OS) or disease-free survival (DFS) when compared to a single agent DTIC.
Recently, investigators, in an effort to combine the activity of biologic response modifiers with chemotherapy, have developed combination biochemotherapy for metastatic melanoma. Legha et al reported an overall objective response rate of 64% with a 5-day biochemotherapy regimen. O'Day et al reported similar results (overall response rate of 57%) using a modified 5-day biochemotherapy regimen.
The above regimens all have significant toxicities and modest response rates. Clearly, more effective less toxic regimens are needed.
Vinorelbine tartrate (Navelbine) and Docetaxel (Taxotere) have both shown activity against melanoma. Additionally, the combination of both drugs has shown enhanced activity against melanoma.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Evaluation of Docetaxel and Vinorelbine Plus Sargramostim in Patients With Metastatic Malignant Melanoma|
- Evaluate the response rate (confirmed and unconfirmed complete and partial responses) of patients with metastatic melanoma when treated with vinorelbine and docetaxel. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Assess the qualitative and quantitative toxicities of docetaxel and vinorelbine [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||April 2003|
|Study Completion Date:||July 2012|
|Primary Completion Date:||July 2012 (Final data collection date for primary outcome measure)|
- Recombinant GM-CSF
Please refer to this study by its ClinicalTrials.gov identifier: NCT00256282
|United States, California|
|Chao Family Comprehensive Cancer Center|
|Orange, California, United States, 92868|
|Principal Investigator:||John P. Fruehauf, MD, PhD||Chao Family Comprehensive Cancer Center|