Study of Gemcitabine and Vinorelbine in Soft Tissue Sarcomas

Sarcoma, Soft Tissue Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00134641
• Other study ID #: 02-282
• Status: Completed
• Phase: Phase 2
• First received: August 24, 2005
• Last updated: December 20, 2007
• Start date: February 2003
• Est. completion date: June 2007

Study information

• Verified date: December 2007
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2007
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sarcoma
• Sarcoma, Soft Tissue

Intervention

Drug:
• gemcitabine

• vinorelbine

Locations

Country	Name	City	State
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	Brigham and Women's Hospital, Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the response of the combination of gemcitabine and vinorelbine in patients with metastatic soft tissue sarcoma
Secondary	To determine the duration of response and the overall survival of patients with metastatic soft tissue sarcoma being treated with this combination
Secondary	to evaluate the safety of this combination in this patient population