Clinical trial NCT00134641: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Sarcoma, Soft Tissue
Keywords: soft tissue sarcoma
metastatic soft tissue sarcoma
gemcitabine
vinorelbine
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: Brigham and Women's Hospital
name: Massachusetts General Hospital
First posted: 2005-08-25
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: To determine the response of the combination of gemcitabine and vinorelbine in patients with metastatic soft tissue sarcoma
Secondary outcomes:
measure: To determine the duration of response and the overall survival of patients with metastatic soft tissue sarcoma being treated with this combination
measure: to evaluate the safety of this combination in this patient population
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Suzanne George, MD
role: PRINCIPAL_INVESTIGATOR
References: