search
Back to results

Study of Gemcitabine and Vinorelbine in Soft Tissue Sarcomas

Primary Purpose

Sarcoma, Soft Tissue

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
gemcitabine
vinorelbine
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcoma, Soft Tissue focused on measuring soft tissue sarcoma, metastatic soft tissue sarcoma, gemcitabine, vinorelbine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dana-Farber Cancer Institute
  • Massachusetts General Hospital

Outcomes

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

Full Information

First Posted
August 24, 2005
Last Updated
December 20, 2007
Sponsor
Dana-Farber Cancer Institute
Collaborators
Brigham and Women's Hospital, Massachusetts General Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT00134641
Brief Title
Study of Gemcitabine and Vinorelbine in Soft Tissue Sarcomas
Official Title
A Phase II Study Evaluating Efficacy of the Combination of Gemcitabine and Vinorelbine in Advanced Soft Tissue Sarcoma
Study Type
Interventional

2. Study Status

Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
February 2003 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
June 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Dana-Farber Cancer Institute
Collaborators
Brigham and Women's Hospital, Massachusetts General Hospital

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoma, Soft Tissue
Keywords
soft tissue sarcoma, metastatic soft tissue sarcoma, gemcitabine, vinorelbine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
gemcitabine
Intervention Type
Drug
Intervention Name(s)
vinorelbine
Primary Outcome Measure Information:
Title
To determine the response of the combination of gemcitabine and vinorelbine in patients with metastatic soft tissue sarcoma
Secondary Outcome Measure Information:
Title
To determine the duration of response and the overall survival of patients with metastatic soft tissue sarcoma being treated with this combination
Title
to evaluate the safety of this combination in this patient population

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suzanne George, MD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Study of Gemcitabine and Vinorelbine in Soft Tissue Sarcomas

We'll reach out to this number within 24 hrs