Adjuvant Chemotherapy for High Risk Uterine Leiomyosarcoma

Sarcoma Alliance for Research through Collaboration

Status and phase: Completed; Phase 2

Conditions: Uterine Neoplasm; Leiomyosarcoma

Treatments: Drug: gemcitabine, docetaxel, doxorubicin

Study type: Interventional

Funder types: Other

Identifiers

NCT00282087

MSKCC05-128 (Other Identifier)

SARC005

Details and patient eligibility

About

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.

Full 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 docetaxel followed by 4 cycles of adriamycin. Following completion of chemotherapy, they will be have repeat imaging at regular intervals to monitor for disease recurrence along with periodic clinical evaluations.

Enrollment: 47 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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47 participants in 1 patient group

gemcitabine/docetaxel then doxorubicin

Other group

Description:

Gemcitabine 900 mg/m2 IV over 90 minutes days 1 and 8 Docetaxel 75 mg/m2 IV day 8 (pre-medication dexamethasone 4-8 mg p.o. bid for 3 days, starting 12-24 hours prior to docetaxel). Doxorubicin 60 mg/m2 IVP every 21 days for 4 cycles (recommend use of central venous catheter access).

Treatment:

Drug: gemcitabine, docetaxel, doxorubicin