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Study of Gemcitabine and Vinorelbine in Soft Tissue Sarcomas

This study has been completed.

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
  Purpose

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   

U.S. FDA Resources

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

Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • To determine the response of the combination of gemcitabine and vinorelbine in patients with metastatic soft tissue sarcoma

Secondary Outcome Measures:
  • 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

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)

Detailed 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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00134641

Locations
United States, Massachusetts
Dana-Farber Cancer Institute    
      Boston, Massachusetts, United States, 02115
Massachusetts General Hospital    
      Boston, Massachusetts, United States, 02115

Sponsors and Collaborators
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Massachusetts General Hospital

Investigators
Principal Investigator:     Suzanne George, MD     Dana-Farber Cancer Institute    
  More Information


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

Keywords provided by Dana-Farber Cancer Institute:
soft tissue sarcoma  
metastatic soft tissue sarcoma  
gemcitabine  
vinorelbine  
metastatic soft tissue sarcoma  

Study placed in the following topic categories:
Neoplasms, Connective and Soft Tissue
Vinorelbine
Malignant mesenchymal tumor
Sarcoma
Gemcitabine
Soft tissue sarcomas

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Radiation-Sensitizing Agents
Therapeutic Uses
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on October 17, 2008




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