Study of Gemcitabine and Vinorelbine in Soft Tissue Sarcomas

Dana-Farber Cancer Institute

Status and phase: Completed; Phase 2

Conditions: Sarcoma, Soft Tissue

Treatments: Drug: vinorelbine; Drug: gemcitabine

Study type: Interventional

Funder types: Other

Identifiers

NCT00134641

02-282

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)