Aminopterin in Treating Patients With Recurrent or Refractory Endometrial Cancer

OBJECTIVES: I. Estimate the antitumor activity of aminopterin in patients with persistent,
recurrent, or refractory endometrial carcinoma who have failed prior first line cytotoxic
chemotherapy. II. Determine the quantitative and qualitative toxic effects of aminopterin in
this patient population. III. Determine the overall patient survival and time to progression
of these patients. IV. Assess the pharmacokinetic profile of these patients.

OUTLINE: Patients receive oral aminopterin every 12 hours twice weekly. Treatment continues
for up to 15 months in the absence of disease progression or unacceptable toxicity. Patients
are followed every 3 months until death.

PROJECTED ACCRUAL: A total of 15-25 patients will be accrued for this study.

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