Docetaxel and Vinorelbine Plus Sargramostim in Metastatic Malignant Melanoma
|ClinicalTrials.gov Identifier: NCT00256282|
Recruitment Status : Completed
First Posted : November 21, 2005
Results First Posted : May 3, 2018
Last Update Posted : May 3, 2018
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Melanoma||Drug: Vinorelbine Drug: Docetaxel Drug: Sargramostim||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||52 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Evaluation of Docetaxel and Vinorelbine Plus Sargramostim in Patients With Metastatic Malignant Melanoma|
|Study Start Date :||April 2003|
|Actual Primary Completion Date :||August 2012|
|Actual Study Completion Date :||August 2012|
Experimental: Docetaxel & Vinorelbine + Sargramostim
Docetaxel, Vinorelbine, and Sargramostim
30 mg/m2 IV over 6-10 min every 14 days
Other Names:Drug: Docetaxel
40mg/m2 IV over 1 hour every 14 days
Other Names:Drug: Sargramostim
250 mcg/m2 subcutaneous (SQ) daily (QD) x 10 days
- Progression-free Survival (PFS) in Patients With AJCC Stage IV Metastatic Melanoma Treated With Docetaxel and Vinorelbine as First-line or Post-first Line (Salvage) Systemic Therapy [ Time Frame: Six months from initial treatment ]The primary endpoint is to evaluate the six-month progression-free survival (PFS) in patients with AJCC stage IV metastatic melanoma treated with docetaxel and vinorelbine as first-line or post-first line (salvage) systemic therapy. Progressive disease is defined as any new lesion or a greater than or equal to 20% increase in the largest perpendicular diameter of the sum of the T-lesions identified on contrast enhanced CT or MRI scan.
- Percentage of Patients Alive at One Year [ Time Frame: 1 year ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|