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Status:

COMPLETED

Adjuvant Chemotherapy for High Risk Uterine Leiomyosarcoma

Lead Sponsor:

Sarcoma Alliance for Research through Collaboration

Conditions:

Leiomyosarcoma

Uterine Neoplasm

Eligibility:

FEMALE

18+ years

Phase:

PHASE2

Brief Summary

The purpose of this trial is to study the benefits of giving chemotherapy to women after they have had surgical resection of their primary disease and have no evidence of disease remaining(known as ad...

Detailed Description

Patients with a diagnosis of early-stage uterine leiomyosarcoma have a 70% chance of relapse or recurrence of their disease. Patients enrolled in this trial will receive 4 cycles of gemcitabine and do...

Eligibility Criteria

Inclusion

  • ≥ 18 years of age
  • high risk uterine LMS, FIGO stage I or II
  • pathology review of LMS high grade and /or mitotic rate greater than or equal to 5 mitoses/10 hpf
  • no longer than 12 weeks from surgical resection of cancer
  • no evidence of residual disease
  • ECOG 0 or 1
  • ANC ≥ 1,500, hemoglobin ≥ 8.0, platelets ≥100,000
  • creatinine ≤ 1.5 x institutional upper limits of normal
  • adequate liver function
  • neuropathy (sensory and motor) ≤ CTC grade 1
  • negative pregnancy test
  • signed consent

Exclusion

  • patients with other invasive malignancies
  • prior therapy with gemcitabine or docetaxel or doxorubicin
  • hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
  • women who are breast feeding
  • cardiac ejection fraction \<50%
  • prior pelvic irradiation
  • treatment with hormone replacement or anti-hormonal agents or other cytotoxic agents

Key Trial Info

Start Date :

January 1 2006

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 1 2012

Estimated Enrollment :

47 Patients enrolled

Trial Details

Trial ID

NCT00282087

Start Date

January 1 2006

End Date

January 1 2012

Last Update

December 1 2014

Active Locations (12)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 3 (12 locations)

1

Washington Cancer Institute/Washington Hospital Center (Medstar)

Washington D.C., District of Columbia, United States, 20010

2

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States, 33612

3

Winship Cancer Institute at Emory University

Atlanta, Georgia, United States, 30308

4

University of Chicago

Chicago, Illinois, United States, 60637