Study of Gemcitabine and Vinorelbine in Soft Tissue Sarcomas

December 20, 2007 updated by: Dana-Farber Cancer Institute

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To determine the response of the combination of gemcitabine and vinorelbine in patients with metastatic soft tissue sarcoma

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dana-Farber Cancer Institute

Collaborators

Massachusetts General Hospital
Brigham and Women's Hospital

Investigators

  • Principal Investigator: Suzanne George, MD, Dana-Farber Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2003

Primary Completion (Actual)

June 1, 2007

Study Completion (Actual)

June 1, 2007

Study Registration Dates

First Submitted

August 24, 2005

First Submitted That Met QC Criteria

August 24, 2005

First Posted (Estimate)

August 25, 2005

Study Record Updates

Last Update Posted (Estimate)

December 21, 2007

Last Update Submitted That Met QC Criteria

December 20, 2007

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 02-282

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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