Study of Gemcitabine and Vinorelbine in Soft Tissue Sarcomas

Phase 2

Completed

• Conditions: Sarcoma, Soft Tissue

• Registration Number: NCT00134641
• Lead Sponsor: Dana-Farber Cancer Institute

Brief 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.

Study Timeline

• Study Start: 2003-02
• Study First Submitted: 2005-08-24
• Study First Submitted QC: 2005-08-24
• Study First Posted: 2005-08-25
• Primary Completion: 2007-06
• Study Completion: 2007-06
• Status Verified: 2007-12
• Last Update Submitted: 2007-12-20
• Last Update Posted: 2007-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Histologic diagnosis of unresectable or metastatic soft tissue sarcoma
• Measurable disease outside of a prior irradiated area
• ECOG performance status 0,1, or 2.
• 0 or 1 prior regimens for advanced disease.
• Adequate end organ function, defined as bilirubin < 1.8; SGOT/SGPT < 2.5 x upper limit of normal (ULN); creatinine < 1.5 x ULN.
• Negative pregnancy test
• Life expectancy of greater than 3 months

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Exclusion Criteria

• Patient has received any investigational agents within 28 days of first day of study drug dosing
• Two or more prior regimens for advanced disease
• Prior gemcitabine or vinorelbine
• Another primary malignancy
• Grade III/IV cardia dysfunction
• Female patients who are pregnant or breast-feeding
• Severe and/or life-threatening medical disease
• Known diagnosis of HIV infection
• Prior chemotherapy within 4 weeks prior to study entry
• Major surgery within 2 weeks prior to study entry
• Known hypersensitivity to either gemcitabine or vinorelbine

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
To determine the response of the combination of gemcitabine and vinorelbine in patients with metastatic soft tissue sarcoma

Secondary Outcome Measures

Name	Time	Method
To determine the duration of response and the overall survival of patients with metastatic soft tissue sarcoma being treated with this combination
to evaluate the safety of this combination in this patient population

Trial Locations

Locations (2)

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States