Study of Gemcitabine and Vinorelbine in Soft Tissue Sarcomas

This study has been completed.
Sponsor:
Collaborators:
Brigham and Women's Hospital
Massachusetts General Hospital
Information provided by:
Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00134641
First received: August 24, 2005
Last updated: December 20, 2007
Last verified: December 2007

August 24, 2005
December 20, 2007
February 2003
June 2007   (final data collection date for primary outcome measure)
To determine the response of the combination of gemcitabine and vinorelbine in patients with metastatic soft tissue sarcoma
To determine the response of the combination of gemcitabine and vinorelbine in patients with metastatic soft tissue sarcoma.
Complete list of historical versions of study NCT00134641 on ClinicalTrials.gov Archive Site
  • 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
  • To determine the duration of response and the overall survival of patients with metastatic sofr tissue sarcoma being treated with this combination,
  • to evaluate the safety of this combination in this patient population.
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Sarcoma, Soft Tissue
  • Drug: gemcitabine
  • Drug: vinorelbine
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
June 2007
June 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00134641
02-282
Not Provided
Not Provided
Dana-Farber Cancer Institute
  • Brigham and Women's Hospital
  • Massachusetts General Hospital
Principal Investigator: Suzanne George, MD Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP