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Phase II Trial of Aminopterin in Patients With Persistent or Recurrent Endometrial Carcinoma


Phase 2
N/A
N/A
Open (Enrolling)
Female
Endometrial Cancer

Thank you

Trial Information

Phase II Trial of Aminopterin in Patients With Persistent or Recurrent Endometrial Carcinoma


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

David S. Miller, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Simmons Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000066974

NCT ID:

NCT00003821

Start Date:

January 1998

Completion Date:

Related Keywords:

  • Endometrial Cancer
  • recurrent endometrial carcinoma
  • Endometrial Neoplasms
  • Sarcoma, Endometrial Stromal
  • Adenoma

Name

Location

Simmons Cancer Center - DallasDallas, Texas  75235-9154
East Carolina University School of MedicineGreenville, North Carolina  27858-4354
University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin  53792
Texas Oncology, P.A.Dallas, Texas  75246
Division of Gynecologic OncologySaint Louis, Missouri  63110
Gynecologic Oncologists of NE OhioAkron, Ohio  44302