Adjuvant Chemotherapy for High Risk Uterine Leiomyosarcoma

• Status: Completed
• Trial end date: 2012-01-01
• Target enrollment: 0
• Participant gender: Female

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 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sarcoma Alliance for Research through Collaboration
• Treatments: Docetaxel; Doxorubicin; Gemcitabine; Liposomal doxorubicin

Criteria

Inclusion Criteria:

• ≥ 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 Criteria:

• 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