Adjuvant Chemotherapy for High Risk Uterine Leiomyosarcoma

Completed · Phase 2

Conditions studied: Leiomyosarcoma, Uterine Neoplasm

In brief

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 adjuvant therapy). The major objective of this study is to determine the progression free survival. The goal is to prevent relapse or recurrence of their uterine leiomyosarcoma.

Key facts

Study ID

NCT00282087

Run by

Sarcoma Alliance for Research through Collaboration

People needed

47

Starts

2006-01-01

Expected to finish

2012-01-01

Last updated by the study team

2014-12-01

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• ≥ 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

You may not qualify if…

• 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

Where it is running

• Washington Cancer Institute/Washington Hospital Center (Medstar) — Washington D.C., District of Columbia, United States
• H. Lee Moffitt Cancer Center and Research Institute — Tampa, Florida, United States
• Winship Cancer Institute at Emory University — Atlanta, Georgia, United States
• University of Chicago — Chicago, Illinois, United States
• St. Vincent Gynecologic Oncology — Indianapolis, Indiana, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Massachusetts General — Boston, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Nebraska Methodist Hospital — Omaha, Nebraska, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Pennsylvania Oncology Hematology Associates — Philadelphia, Pennsylvania, United States
• MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.