Study of Gemcitabine and Vinorelbine in Soft Tissue Sarcomas

Study Overview
=================
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.

Official Title
-----------------
A Phase II Study Evaluating Efficacy of the Combination of Gemcitabine and Vinorelbine in Advanced Soft Tissue Sarcoma

Conditions
-----------------
Sarcoma, Soft Tissue

Intervention / Treatment
-----------------
* Drug: gemcitabine
* Drug: vinorelbine


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: gemcitabine|nan|
|Drug: vinorelbine|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the response of the combination of gemcitabine and vinorelbine in patients with metastatic soft tissue sarcoma |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
soft tissue sarcoma, metastatic soft tissue sarcoma, gemcitabine, vinorelbine