NCT00134641

Study of Gemcitabine and Vinorelbine in Soft Tissue Sarcomas

A Phase II Study Evaluating Efficacy of the Combination of Gemcitabine and Vinorelbine in Advanced Soft Tissue Sarcoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (planned)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if the combination of gemcitabine and vinorelbine is effective in treating patients with advanced soft tissue sarcoma.

Detailed description

Patients will receive both gemcitabine and vinorelbine once a week for two weeks and then one week with no chemotherapy (1 cycle equals 21 days). Gemcitabine and vinorelbine will be administered on day 1 and day 8 of each cycle. Blood tests will be performed on each day chemotherapy is administered. A CT scan will be done after every 2 cycles (approximately every 6 weeks) to determine the effects of the chemotherapy on the sarcoma. A physical exam will be performed at the start of chemotherapy and at least every three weeks thereafter. Patients will remain on this study as long as the disease does not progress or there are no unacceptable side effects.

Conditions

• Sarcoma, Soft Tissue

Interventions

Type	Name	Description
DRUG	gemcitabine
DRUG	vinorelbine

Timeline

• Start date: 2003-02-01
• Primary completion: 2007-06-01
• Completion: 2007-06-01
• First posted: 2005-08-25
• Last updated: 2007-12-21

Locations

2 sites across 1 country: United States