Overview

This trial is active, not recruiting.

Condition endometrial cancer
Treatment aminopterin
Phase phase 2
Sponsor Genzyme, a Sanofi Company
Start date January 1998
Trial size 25 participants
Trial identifier NCT00003821, CDR0000066974, ILEX-AMT221, ILEX-AMT221-A1, NCI-V99-1531

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Primary purpose treatment

Eligibility Criteria

Female participants of any age.

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

Additional Information

Official title Phase II Trial of Aminopterin in Patients With Persistent or Recurrent Endometrial Carcinoma
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2014.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).