Recurrent Uterine Corpus Sarcoma Clinical Trial
Official title:
A Randomized Phase III Evaluation of Docetaxel (NSC #628503) and Gemcitabine (NSC #613327) Plus G-CSF With Bevacizumab (NSC #704865) Versus Docetaxel (NSC #628503) and Gemcitabine (NSC #613327) Plus G-CSF With Placebo in the Treatment of Recurrent or Advanced Leiomyosarcoma of the Uterus
This randomized phase III trial is studying gemcitabine hydrochloride, docetaxel, and bevacizumab to see how well they work compared with gemcitabine hydrochloride, docetaxel, and a placebo in treating patients with advanced or recurrent uterine leiomyosarcoma. Drugs used in chemotherapy, such as gemcitabine hydrochloride and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. It is not yet known whether gemcitabine hydrochloride and docetaxel are more effective when given with or without bevacizumab in treating uterine leiomyosarcoma.
PRIMARY OBJECTIVES:
I. To determine whether the addition of bevacizumab to fixed-dose rate gemcitabine-docetaxel
reduces the progression-free survival (PFS) event rate when compared to gemcitabine-docetaxel
plus placebo in patients with advanced or recurrent uterine leiomyosarcoma (LMS).
SECONDARY OBJECTIVES:
I. To determine the objective response rate, as measured by RECIST, of patients treated with
fixed-dose rate gemcitabine-docetaxel with bevacizumab, compared with the objective response
rate of patients treated with fixed-dose rate gemcitabine-docetaxel with placebo.
II. To determine if the addition of bevacizumab to the combination of gemcitabine and
docetaxel increases overall survival in patients with advanced or recurrent uterine LMS.
III. To determine the toxicity profile of fixed-dose rate gemcitabine-docetaxel with and
without bevacizumab in this patient population.
IV. To bank formalin-fixed and paraffin-embedded (FFPE) tumor tissue for research.
OUTLINE: This is a multicenter study. Patients are stratified according to prior whole-pelvic
radiotherapy (yes vs no). Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive a placebo IV over 30-90 minutes on day 1, gemcitabine hydrochloride
IV over 90 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8. Patients also
receive filgrastim subcutaneously (SC) on days 9-15 or pegfilgrastim SC on day 9 or 10.
ARM II: Patients receive bevacizumab IV over 30-90 minutes on day 1, gemcitabine
hydrochloride IV over 90 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8.
Patients also receive filgrastim SC on days 9-15 or pegfilgrastim SC on day 9 or 10.
In both arms, courses repeat every 21 days in the absence of disease progression or
unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 2 years and
then every 6 months for 3 years.
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