Clinical trial NCT00003821: Aminopterin in Treating Patients With Recurrent or Refractory Endometrial Cancer
Official title: Phase II Trial of Aminopterin in Patients With Persistent or Recurrent Endometrial Carcinoma
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Endometrial Cancer
Keywords: recurrent endometrial carcinoma
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2004-08-04
Enrollment: 0
Sex: FEMALE
Maximum age (years): 120
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Division of Gynecologic Oncology
state: Missouri
city: Greenville
country: United States
facility: East Carolina University School of Medicine
state: North Carolina
city: Akron
country: United States
facility: Gynecologic Oncologists of NE Ohio
state: Ohio
city: Dallas
country: United States
facility: Simmons Cancer Center - Dallas
state: Texas
city: Dallas
country: United States
facility: Texas Oncology, P.A.
state: Texas
city: Madison
country: United States
facility: University of Wisconsin Comprehensive Cancer Center
state: Wisconsin
Study officials:
affiliation: Simmons Cancer Center
name: David S. Miller, MD
role: STUDY_CHAIR
References: