drugset / Trial / NCT00256282

Docetaxel and Vinorelbine Plus Sargramostim in Metastatic Malignant Melanoma

NCT00256282 ↗

Phase 2 Completed 52 enrolled John P. Fruehauf Bayer · collab
NaSingle-groupOpen-labelTreatment

Summary

This is a Phase II Evaluation of Docetaxel and Vinorelbine Plus Sargramostim in subjects who have metastatic melanoma which has advanced beyond the point at which local therapies such as surgery or radiation therapy would be helpful. Without effective treatment, metastatic melanoma is usually a severe and fatal disease. Chemotherapy agents or combinations of chemotherapy agents have produced tumor shrinkage in some patients, which has occasionally persisted. This research involves treatment with a combination of chemotherapy drugs known to be active against melanoma alone. The investigational purpose of this study is to determine if the combination of docetaxel, vinorelbine and sargramostim will produce a response (complete or partial) in metastasis melanoma. The researchers also wants to find out what side effects are associated with this combination of drugs.

Timeline

Start
2003-04
Primary completion
2012-08
Completion
2012-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Docetaxel Small molecule 40 mg/m2 Intravenous
Subject Vinorelbine Small molecule 30 mg/m2 Intravenous
Subject sargramostim Protein / enzyme biologic 250 ug/m2 Subcutaneous

Indications