NCT01533207

Gemcitabine Hydrochloride and Docetaxel Followed by Doxorubicin Hydrochloride or Observation in Treating Patients With High-Risk Uterine Leiomyosarcoma Previously Removed by Surgery

A Phase III Randomized Trial of Gemcitabine (NSC# 613327) Plus Docetaxel (NSC# 628503) Followed by Doxorubicin (NSC# 123127) Versus Observation for Uterus-Limited, High Grade Uterine Leiomyosarcoma

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Gynecologic Oncology Group · Network
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This randomized phase III trial studies how well gemcitabine hydrochloride and docetaxel followed by doxorubicin hydrochloride work compared to observation in treating patients with high-risk uterine leiomyosarcoma previously removed by surgery. Drugs used in chemotherapy, such as gemcitabine hydrochloride, docetaxel, and doxorubicin hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether combination therapy after surgery is an effective treatment for uterine leiomyosarcoma.

Detailed description

PRIMARY OBJECTIVES: I. To determine whether overall survival of patients with uterus-limited high-grade leiomyosarcoma is superior among patients assigned to treatment with adjuvant gemcitabine hydrochloride (gemcitabine) plus docetaxel followed by doxorubicin hydrochloride compared to patients assigned to observation. SECONDARY OBJECTIVES: I. To determine whether treatment with adjuvant gemcitabine plus docetaxel followed by doxorubicin improves recurrence-free survival of patients with uterus-limited high-grade leiomyosarcoma compared to observation. II. To explore the impact of potential predictors of recurrence or death such as patient age, institution reported tumor size, cervix involvement (yes or no), and mitotic rate. OUTLINE: Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive adjuvant gemcitabine hydrochloride IV over 70-90 minutes on days 1 and 8 and docetaxel IV over 30-60 minutes on day 8. Patients also receive filgrastim subcutaneously (SC) on days 9-15 or pegfilgrastim SC on day 9 or 10. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients then undergo computed tomography (CT) and/or magnetic resonance imaging (MRI). Patients with no evidence of disease receive doxorubicin hydrochloride IV every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients also receive filgrastim SC on days 2-8 or pegfilgrastim SC on day 2 or 3. Arm II: Patients undergo clinical observation. After completion of study treatment, patients in both arms are followed up every 4 months for 3 years and then every 6 months for 2 years.

Conditions

• Stage I Uterine Sarcoma AJCC v7
• Uterine Corpus Leiomyosarcoma

Interventions

Type	Name	Description
OTHER	Clinical Observation	Patients followed clinically
DRUG	Docetaxel	Given IV
DRUG	Doxorubicin Hydrochloride	Given IV
BIOLOGICAL	Filgrastim	Given subcutaneously (SC)
DRUG	Gemcitabine Hydrochloride	Given IV
BIOLOGICAL	Pegfilgrastim	Given SC

Timeline

• Start date: 2012-06-04
• Primary completion: 2018-06-30
• Completion: 2019-02-09
• First posted: 2012-02-15
• Last updated: 2020-04-28
• Results posted: 2020-04-06

Locations

623 sites across 8 countries: United States, Belgium, France, Netherlands, Norway, Spain, United Kingdom, Venezuela