Piritrexim in Treating Patients With Advanced Cancer of the Urinary Tract

Sponsor

Eastern Cooperative Oncology Group (Other)

Overall Status

Completed

CT.gov ID

NCT00002914

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Locations

Duration (Months)

1.4

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Bladder Cancer Transitional Cell Cancer of the Renal Pelvis and Ureter Urethral Cancer	Drug: piritrexim	Phase 2

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Primary Purpose:

Treatment

Official Title:

PHASE II STUDY OF PIRITREXIM IN ADVANCED CARCINOMA OF THE UROTHELIUM

Study Start Date :

May 1, 1997

Actual Primary Completion Date :

Jun 1, 2001

Actual Study Completion Date :

Mar 1, 2004

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Emory University Hospital - Atlanta	Atlanta	Georgia	United States	30322
2	Veterans Affairs Medical Center - Atlanta (Decatur)	Decatur	Georgia	United States	30033
3	Robert H. Lurie Comprehensive Cancer Center, Northwestern University	Chicago	Illinois	United States	60611
4	Veterans Affairs Medical Center - Chicago (Lakeside)	Chicago	Illinois	United States	60611
5	CCOP - Illinois Oncology Research Association	Peoria	Illinois	United States	61602
6	CCOP - Carle Cancer Center	Urbana	Illinois	United States	61801
7	Indiana University Cancer Center	Indianapolis	Indiana	United States	46202-5265
8	Veterans Affairs Medical Center - Indianapolis (Roudebush)	Indianapolis	Indiana	United States	46202
9	CCOP - Cedar Rapids Oncology Project	Cedar Rapids	Iowa	United States	52403-1206
10	CCOP - Iowa Oncology Research Association	Des Moines	Iowa	United States	10309-1016
11	CCOP - Kalamazoo	Kalamazoo	Michigan	United States	49007-3731
12	CCOP - Metro-Minnesota	Saint Louis Park	Minnesota	United States	55416
13	Veterans Affairs Medical Center - East Orange	East Orange	New Jersey	United States	07018-1095
14	CCOP - Northern New Jersey	Hackensack	New Jersey	United States	07601
15	Albert Einstein Comprehensive Cancer Center	Bronx	New York	United States	10461
16	University of Rochester Cancer Center	Rochester	New York	United States	14642
17	CCOP - Merit Care Hospital	Fargo	North Dakota	United States	58122
18	Ireland Cancer Center	Cleveland	Ohio	United States	44106-5065
19	Cleveland Clinic Cancer Center	Cleveland	Ohio	United States	44195
20	CCOP - Toledo Community Hospital Oncology Program	Toledo	Ohio	United States	43623-3456
21	CCOP - St. Francis Hospital/Natalie Warren Bryant Cancer Center	Tulsa	Oklahoma	United States	74136
22	CCOP - Geisinger Clinical and Medical Center	Danville	Pennsylvania	United States	17822-2001
23	Veterans Affairs Medical Center - Nashville	Nashville	Tennessee	United States	37212
24	Vanderbilt Cancer Center	Nashville	Tennessee	United States	37232-6838
25	Veterans Affairs Medical Center - Madison	Madison	Wisconsin	United States	53705
26	University of Wisconsin Comprehensive Cancer Center	Madison	Wisconsin	United States	53792
27	Medical College of Wisconsin	Milwaukee	Wisconsin	United States	53226
28	Veterans Affairs Medical Center - Milwaukee (Zablocki)	Milwaukee	Wisconsin	United States	53295
29	Pretoria Academic Hospital	Pretoria		South Africa	0001