Piritrexim in Treating Patients With Advanced Cancer of the Urinary Tract

Bladder Cancer Clinical Trial

Official title:

PHASE II STUDY OF PIRITREXIM IN ADVANCED CARCINOMA OF THE UROTHELIUM

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002914
• Other study ID #: CDR0000065289
• Secondary ID: E-3896
• Status: Completed
• Phase: Phase 2
• Start date: July 15, 1997
• Est. completion date: March 2004

Study information

• Verified date: June 2023
• Source: Eastern Cooperative Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 piritrexim in treating patients with advanced cancer of the urinary tract that has not responded to previous treatment.

Description:

OBJECTIVES: I. Evaluate the antineoplastic activity of piritrexim and its effect on the survival of patients with advanced urothelial carcinoma previously treated with systemic cytotoxic chemotherapy. II. Evaluate the toxicity of piritrexim in these patients.

OUTLINE: Patients receive piritrexim by mouth 3 times daily, 5 days a week, for 3 weeks followed by 1 week of rest. Patients with responding or stable disease continue treatment every 4 weeks until unacceptable toxicity or progression intervenes.

PROJECTED ACCRUAL: A maximum of 40 patients will be entered over 5-6 months if at least 1 response is observed in the first 14 evaluable patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 2004
• Est. primary completion date: June 2001
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

DISEASE CHARACTERISTICS: Histologically confirmed transitional cell carcinoma, squamous cell, or adenocarcinoma of the renal pelvis, ureter, bladder, or urethra Progressing regional or metastatic disease after one prior systemic or intra- arterial chemotherapy regimen Bidimensionally measurable disease, e. g.: Pulmonary nodules Palpable lymph nodes Cutaneous or subcutaneous nodules Mediastinal tumor or hepatic metastases if clearly measurable on CT No prior radiotherapy to indicator lesion unless documented progression since completion of radiotherapy

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0 or 1 Hematopoietic:

(within 2 weeks prior to entry) WBC at least 4,000/mm3 Platelet count at least 100,000/mm3 Hepatic: (within 2 weeks prior to entry) Bilirubin no greater than 2.0 mg/dL AST no greater than twice normal Renal: (within 2 weeks prior to entry) Creatinine no greater than 1.5 mg/dL OR Creatinine clearance greater than 40 mL/min Other: No active unresolved infection No concurrent parenteral antibiotics At least 7 days since parenteral antibiotics No history of prior malignancy within 5 years except: Curatively treated nonmelanomatous skin cancer In situ cancer of the cervix Not pregnant or nursing Adequate contraception required of fertile patients Physically and medically able to take oral medications

PRIOR CONCURRENT THERAPY: Biologic therapy: One prior systemic biological response modifier therapy allowed At least 3 weeks since biologic response modifier therapy and recovered Chemotherapy: See Disease Characteristics At least 3 weeks since chemotherapy and recovered Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since radiotherapy Surgery: At least 3 weeks since major surgery and recovered

Related Conditions & MeSH terms

• Bladder Cancer
• Carcinoma, Transitional Cell
• Kidney Neoplasms
• Transitional Cell Cancer of the Renal Pelvis and Ureter
• Ureteral Neoplasms
• Urethral Cancer
• Urethral Neoplasms
• Urinary Bladder Neoplasms

Intervention

Drug:
• piritrexim

Locations

Country	Name	City	State
South Africa	Pretoria Academic Hospital	Pretoria
United States	Emory University Hospital - Atlanta	Atlanta	Georgia
United States	Albert Einstein Comprehensive Cancer Center	Bronx	New York
United States	CCOP - Cedar Rapids Oncology Project	Cedar Rapids	Iowa
United States	Robert H. Lurie Comprehensive Cancer Center, Northwestern University	Chicago	Illinois
United States	Veterans Affairs Medical Center - Chicago (Lakeside)	Chicago	Illinois
United States	Cleveland Clinic Cancer Center	Cleveland	Ohio
United States	Ireland Cancer Center	Cleveland	Ohio
United States	CCOP - Geisinger Clinical and Medical Center	Danville	Pennsylvania
United States	Veterans Affairs Medical Center - Atlanta (Decatur)	Decatur	Georgia
United States	CCOP - Iowa Oncology Research Association	Des Moines	Iowa
United States	Veterans Affairs Medical Center - East Orange	East Orange	New Jersey
United States	CCOP - Merit Care Hospital	Fargo	North Dakota
United States	CCOP - Northern New Jersey	Hackensack	New Jersey
United States	Indiana University Cancer Center	Indianapolis	Indiana
United States	Veterans Affairs Medical Center - Indianapolis (Roudebush)	Indianapolis	Indiana
United States	CCOP - Kalamazoo	Kalamazoo	Michigan
United States	University of Wisconsin Comprehensive Cancer Center	Madison	Wisconsin
United States	Veterans Affairs Medical Center - Madison	Madison	Wisconsin
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Veterans Affairs Medical Center - Milwaukee (Zablocki)	Milwaukee	Wisconsin
United States	Vanderbilt Cancer Center	Nashville	Tennessee
United States	Veterans Affairs Medical Center - Nashville	Nashville	Tennessee
United States	CCOP - Illinois Oncology Research Association	Peoria	Illinois
United States	University of Rochester Cancer Center	Rochester	New York
United States	CCOP - Metro-Minnesota	Saint Louis Park	Minnesota
United States	CCOP - Toledo Community Hospital Oncology Program	Toledo	Ohio
United States	CCOP - St. Francis Hospital/Natalie Warren Bryant Cancer Center	Tulsa	Oklahoma
United States	CCOP - Carle Cancer Center	Urbana	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Eastern Cooperative Oncology Group	National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  South Africa, 

References & Publications (1)

Roth BJ, Manola J, Dreicer R, Graham D, Wilding G; Eastern Cooperative Oncology Group. Piritrexim in advanced, refractory carcinoma of the urothelium (E3896): a phase II trial of the Eastern Cooperative Oncology Group. Invest New Drugs. 2002 Nov;20(4):425 — View Citation