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Sponsors and Collaborators: |
Dana-Farber Cancer Institute Brigham and Women's Hospital Massachusetts General Hospital |
Information provided by: | Dana-Farber Cancer Institute |
ClinicalTrials.gov Identifier: | NCT00134641 |
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.
Condition | Intervention | Phase |
Sarcoma, Soft Tissue |
Drug: gemcitabine Drug: vinorelbine |
Phase II |
MedlinePlus related topics: | Cancer Soft Tissue Sarcoma |
ChemIDplus related topics: | Vinorelbine Vinorelbine tartrate Gemcitabine hydrochloride Gemcitabine |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Study Evaluating Efficacy of the Combination of Gemcitabine and Vinorelbine in Advanced Soft Tissue Sarcoma |
Estimated Enrollment: | 40 |
Study Start Date: | February 2003 |
Study Completion Date: | June 2007 |
Primary Completion Date: | June 2007 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Massachusetts | |||||
Dana-Farber Cancer Institute | |||||
Boston, Massachusetts, United States, 02115 | |||||
Massachusetts General Hospital | |||||
Boston, Massachusetts, United States, 02115 |
Dana-Farber Cancer Institute |
Brigham and Women's Hospital |
Massachusetts General Hospital |
Principal Investigator: | Suzanne George, MD | Dana-Farber Cancer Institute |
Study ID Numbers: | 02-282 |
First Received: | August 24, 2005 |
Last Updated: | December 20, 2007 |
ClinicalTrials.gov Identifier: | NCT00134641 |
Health Authority: | United States: Institutional Review Board |
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