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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: 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 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 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. (exploratory)

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 completi
Sponsor: Gynecologic Oncology Group

Current Primary Outcome: Overall survival [ Time Frame: From study entry to time of death or the date of last contact, assessed up to 5 years ]

The logrank test will be used to test the null hypothesis of independence between survival and randomized treatment. Kaplan-Meier estimates will be used to graph survival distribution curves for each treatment arm. The death hazard ratio (experimental to control) will be estimated using a Cox Proportional Hazards model and a 95% Wald confidence interval will be reported.


Original Primary Outcome: Overall survival

Current Secondary Outcome:

  • Incidence of adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: Up to 5 years ]
  • Recurrence-free survival [ Time Frame: From study entry to time of recurrence or death, whichever occurs first, assessed up to 5 years ]
    The recurrence or death hazard ratio (experimental to control) will be estimated using Cox's proportional hazards model and a 95% Wald confidence interval will be reported. The logrank test will be used to test the null hypothesis of independence between recurrence-free survival and randomized treatment.


Original Secondary Outcome:

  • Recurrence-free survival
  • Frequency and severity of adverse events


Information By: Gynecologic Oncology Group

Dates:
Date Received: February 11, 2012
Date Started: June 2012
Date Completion:
Last Updated: May 2, 2017
Last Verified: May 2017