Overview

Aminopterin in Treating Patients With Recurrent or Refractory Endometrial Cancer

Status:
Withdrawn
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 aminopterin in treating patients who have refractory or recurrent endometrial cancer.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Genzyme, a Sanofi Company
Treatments:
Aminopterin
Criteria
DISEASE CHARACTERISTICS: Histologically confirmed persistent, recurrent, or refractory
endometrial carcinoma who have failed prior first line chemotherapy Bidimensionally
measurable disease by physical exam or medical imaging techniques (sonography acceptable if
lesion(s) are clearly defined and measurable in two dimensions) Ascites and pleural
effusions are not measurable

PATIENT CHARACTERISTICS: Age: Not specified Performance status: GOG 0-2 Life expectancy: At
least 2 months Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3
Granulocyte count at least 1,500/mm3 Hemoglobin at least 8 g/dL Hepatic: Bilirubin no
greater than 1.5 times upper limit of normal (ULN) SGOT no greater than 3 times ULN
Alkaline phosphatase no greater than 3 times ULN Renal: Creatinine no greater than 2.0
mg/dL Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use
effective contraception No significant infection

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease
Characteristics At least 4 weeks since prior chemotherapy and recovered Endocrine therapy:
Not specified Radiotherapy: At least 4 weeks since prior radiotherapy and recovered
Surgery: At least 4 weeks since prior surgery and recovered Other: At least 4 weeks since
any prior therapy directed at malignant endometrial tumor(s) At least 4 weeks since prior
folate-containing vitamins No concurrent folate-containing vitamins No other concurrent
anticancer therapy