Gemcitabine, Docetaxel, and Filgrastim in Treating Patients With Recurrent or Persistent Leiomyosarcoma or Soft Tissue Sarcoma
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy.
PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine, docetaxel, and filgrastim in treating patients who have recurrent or persistent leiomyosarcoma or soft tissue sarcoma that cannot be removed by surgery.
Small Intestine Cancer
Drug: gemcitabine hydrochloride
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase II Trial of Gemcitabine and Docetaxel in Patients With Unresectable Leiomyosarcoma|
|Study Start Date:||June 1999|
|Study Completion Date:||October 2003|
|Primary Completion Date:||October 2003 (Final data collection date for primary outcome measure)|
- Evaluate the activity of gemcitabine plus docetaxel administered with filgrastim (G-CSF) support, in terms of disease response, in patients with recurrent or persistent unresectable leiomyosarcoma or other soft tissue sarcoma.
- Determine the tolerability of this regimen in these patients.
- Correlate response with tumor expression of the apoptosis-regulating proteins bax, bcl-2, and survivin in these patients.
OUTLINE: Patients are stratified according to prior radiotherapy to the pelvis (yes vs no).
Patients receive gemcitabine IV over 90 minutes on days 1 and 8 followed by docetaxel IV over 1 hour on day 8 and filgrastim (G-CSF) subcutaneously on days 9-15. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients with a partial response may receive 2 additional courses of therapy.
Patients are followed every 3 months for 1 year or until disease progression.
PROJECTED ACCRUAL: A total of 38-82 patients (19-43 with uterine leiomyosarcoma and 19-39 with other soft tissue sarcoma) will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004066
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Study Chair:||Robert Maki, MD, PhD||Memorial Sloan Kettering Cancer Center|