Leiomyosarcoma and undifferentiated endometrial sarcoma of the uterus
Conditions
Interventions
Eligible women with advanced LMS were treated with gemcitabine 900 mg/m2 over 90-minute infusion, on days one and eight, plus docetaxel 70 mg/m2 on day eight, every 3 weeks, without granulocyte colony
Sponsors
Gynecology, Tohoku University Hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Women with advanced or recurrent LMS/UES who had progressed after treatment with one or two prior cytotoxic regimen, and who had measurable disease that was not considered respectable, were eligible. All tumors were histologically confirmed. Prior therapy with gemcitabine or docetaxel was not permitted. Patients were permitted to have had prior pelvic radiotherapy. Patients were required to have ECOG performance status of 0-2, and adequate bone marrow function (absolute neutrophil count (ANC) greater than or equal to 1500/microlitter, and platelets greater than or equal to 100,000/microlitter); renal function (creatinine less than or equal to 1.5 X the institutional upper limit of normal); hepatic function (bilirubin less than or equal to 1.5 X the institutional upper limit of normal, and Serum glutamic oxaloacetic transaminase (SGOT) and alkaline phosphatase less than or equal to 2.5 X the institutional upper limit of normal); and neurologic function (baseline neuropathy, sensory and motor, less than or equal to Common Toxicity Criteria grade 1). All patients signed written, informed consent. The protocol and consent were reviewed and approved annually by participating institutions' Institutional Review Boards.
Exclusion criteria
Exclusion criteria: Patients with a history of other invasive malignancy within the past 5 years were not eligible.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival, Overall survival, Adverse events | — |
Countries
Japan
Contacts
Public ContactTadao Takano
Tohoku University Hospital Gynecology
Outcome results
None listed