Sarcoma Clinical Trial
Official title:
A Phase II Evaluation of Docetaxel (NSC #628503) and Gemcitabine (NSC #613327) Plus G-CSF in the Treatment of Recurrent or Advanced Leiomyosarcoma of the Uterus
RATIONALE: Drugs used in chemotherapy, such as docetaxel and gemcitabine, work in different
ways to stop the growth of tumor cells, either by killing the cells or by stopping them from
dividing. Colony-stimulating factors, such as G-CSF and pegfilgrastim, may increase the
number of immune cells found in bone marrow or peripheral blood and may help the immune
system recover from the side effects of chemotherapy. Giving docetaxel and gemcitabine
together with G-CSF or pegfilgrastim may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving docetaxel and gemcitabine together
with G-CSF or pegfilgrastim works in treating patients with advanced, persistent, or
recurrent uterine leiomyosarcoma.
OBJECTIVES:
- Determine the antitumor activity of docetaxel, gemcitabine, and filgrastim (G-CSF) or
pegfilgrastim in patients with advanced, persistent, or recurrent uterine
leiomyosarcoma.
- Determine the nature and degree of toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to prior pelvic
radiotherapy (yes vs no).
Patients receive gemcitabine IV over 90 minutes on days 1 and 8 and docetaxel IV over 1 hour
on day 8. Patients also receive filgrastim (G-CSF) subcutaneously (SC) on days 9-15 OR
pegfilgrastim SC on day 9. Courses repeat every 21 days in the absence of disease
progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 12-43 patients will be accrued for this study within 12-28
months.
;
Masking: Open Label, Primary Purpose: Treatment
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