Gemcitabine Hydrochloride and Docetaxel With or Without Bevacizumab in Treating Patients With Advanced or Recurrent Uterine Leiomyosarcoma

Conditions

• Recurrent Uterine Corpus Sarcoma
• Stage IIIA Uterine Sarcoma
• Stage IIIB Uterine Sarcoma
• Stage IIIC Uterine Sarcoma
• Stage IVA Uterine Sarcoma
• Stage IVB Uterine Sarcoma
• Uterine Corpus Leiomyosarcoma

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Bevacizumab — BIOLOGICAL
  Given IV
• Docetaxel — DRUG
  Given IV
• Filgrastim — BIOLOGICAL
  Given SC
• Gemcitabine Hydrochloride — DRUG
  Given IV
• Pegfilgrastim — BIOLOGICAL
  Given SC
• Placebo — OTHER
  Given IV

Study Details

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.

Key Dates

First listed

Nov 13, 2009

Start date

Nov 30, 2009

Status verified

May 2026

Primary completion

Sep 30, 2015

Completion

Sep 30, 2015

Study Design

Enrollment

107 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm I Gem+Doce+Placebo
  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.
• Experimental: Arm II Gem+Doce+Bev
  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.

Primary Outcome Measure

Progression-free Survival [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months ]

Locations (201)

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