Overview

Gemcitabine in Treating Patients With Recurrent or Refractory Cancer of the Uterus

Status:
Terminated
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
Female
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of gemcitabine in treating patients with recurrent or refractory cancer of the uterus.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Gynecologic Oncology Group
Collaborator:
National Cancer Institute (NCI)
Treatments:
Gemcitabine
Criteria
DISEASE CHARACTERISTICS: Histologically confirmed recurrent or persistent uterine
leiomyosarcoma that is refractory to curative therapy or standard treatments Failed local
therapeutic measures and considered incurable Measurable disease Not eligible for a higher
priority GOG protocol

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: GOG 0-2 Life expectancy: Not
specified Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3
Granulocyte count at least 1,500/mm3 Hepatic: Bilirubin no greater than 1.5 times normal
SGOT no greater than 3 times normal Alkaline phosphatase no greater than 3 times normal
Renal: Creatinine no greater than 1.5 mg/dL Other: No significant infection At least 5
years since any other invasive malignancy except nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 weeks since prior biologic therapy
Chemotherapy: At least 3 weeks since prior chemotherapy and recovered No prior gemcitabine
No more than 1 prior chemotherapy regimen (single agent or combination therapy) Endocrine
therapy: At least 3 weeks since prior endocrine therapy Radiotherapy: At least 3 weeks
since prior radiotherapy and recovered Surgery: At least 3 weeks since prior surgery and
recovered