Aminopterin in Treating Patients With Recurrent or Refractory Endometrial Cancer

NCT00003821 | Withdrawn Phase 2

• 4 other identifiers: CDR0000066974ILEX-AMT221-A1ILEX-AMT221NCI-V99-1531
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 6

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.

Conditions

Endometrial Cancer

Keywords

recurrent endometrial carcinoma

Interventions

aminopterin DRUG

Eligibility Criteria

• Age: Up to 120 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Genzyme, a Sanofi Company: lead

Study Sites (6)

Division of Gynecologic Oncology

St Louis, Missouri, 63110, United States

Location

East Carolina University School of Medicine

Greenville, North Carolina, 27858-4354, United States

Location

Gynecologic Oncologists of NE Ohio

Akron, Ohio, 44302, United States

Location

Simmons Cancer Center - Dallas

Dallas, Texas, 75235-9154, United States

Location

Texas Oncology, P.A.

Dallas, Texas, 75246, United States

Location

University of Wisconsin Comprehensive Cancer Center

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

Aminopterin

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• David S. Miller, MD

  Simmons Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: August 4, 2004
• Study Start: January 1, 1998
• Last Updated: September 18, 2018

Record last verified: 2000-07

Locations

US (6)