A Phase II Study Evaluating Efficacy of the Combination of Gemcitabine and Vinorelbine in Advanced Soft Tissue Sarcoma
18 Years
N/A
Both
Sarcoma, Soft Tissue
Trial Information
A Phase II Study Evaluating Efficacy of the Combination of Gemcitabine and Vinorelbine in Advanced Soft Tissue Sarcoma
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To determine the response of the combination of gemcitabine and vinorelbine in patients with metastatic soft tissue sarcoma
Principal Investigator
Suzanne George, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Dana-Farber Cancer Institute
Authority:
United States: Institutional Review Board
Study ID:
02-282
NCT ID:
NCT00134641
Start Date:
February 2003
Completion Date:
June 2007
Related Keywords:
- Sarcoma, Soft Tissue
- soft tissue sarcoma
- metastatic soft tissue sarcoma
- gemcitabine
- vinorelbine
- Sarcoma
Name | Location |
|---|---|
| Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
| Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |
