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PHASE II STUDY OF PIRITREXIM IN ADVANCED CARCINOMA OF THE UROTHELIUM


Phase 2
18 Years
N/A
Not Enrolling
Both
Bladder Cancer, Transitional Cell Cancer of the Renal Pelvis and Ureter, Urethral Cancer

Thank you

Trial Information

PHASE II STUDY OF PIRITREXIM IN ADVANCED CARCINOMA OF THE UROTHELIUM


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Bruce J. Roth, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Vanderbilt-Ingram Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000065289

NCT ID:

NCT00002914

Start Date:

May 1997

Completion Date:

March 2004

Related Keywords:

  • Bladder Cancer
  • Transitional Cell Cancer of the Renal Pelvis and Ureter
  • Urethral Cancer
  • recurrent bladder cancer
  • transitional cell carcinoma of the bladder
  • squamous cell carcinoma of the bladder
  • adenocarcinoma of the bladder
  • recurrent urethral cancer
  • recurrent transitional cell cancer of the renal pelvis and ureter
  • Urinary Bladder Neoplasms
  • Urethral Neoplasms
  • Carcinoma, Transitional Cell
  • Kidney Neoplasms
  • Ureteral Neoplasms
  • Urologic Neoplasms

Name

Location

Albert Einstein Comprehensive Cancer CenterBronx, New York  10461
Emory University Hospital - AtlantaAtlanta, Georgia  30322
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
University of Rochester Cancer CenterRochester, New York  14642
Cleveland Clinic Cancer CenterCleveland, Ohio  44195
Ireland Cancer CenterCleveland, Ohio  44106-5065
Robert H. Lurie Comprehensive Cancer Center, Northwestern UniversityChicago, Illinois  60611
Veterans Affairs Medical Center - Atlanta (Decatur)Decatur, Georgia  30033
CCOP - Illinois Oncology Research AssociationPeoria, Illinois  61602
CCOP - Carle Cancer CenterUrbana, Illinois  61801
Veterans Affairs Medical Center - Indianapolis (Roudebush)Indianapolis, Indiana  46202
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
CCOP - KalamazooKalamazoo, Michigan  49007-3731
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
Veterans Affairs Medical Center - East OrangeEast Orange, New Jersey  07018-1095
CCOP - Northern New JerseyHackensack, New Jersey  07601
Vanderbilt Cancer CenterNashville, Tennessee  37232-6838
CCOP - Cedar Rapids Oncology ProjectCedar Rapids, Iowa  52403-1206
CCOP - Merit Care HospitalFargo, North Dakota  58122
CCOP - Toledo Community Hospital Oncology ProgramToledo, Ohio  43623-3456
CCOP - Geisinger Clinical and Medical CenterDanville, Pennsylvania  17822-2001
Medical College of WisconsinMilwaukee, Wisconsin  53226
Veterans Affairs Medical Center - MadisonMadison, Wisconsin  53705
University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin  53792
Veterans Affairs Medical Center - Milwaukee (Zablocki)Milwaukee, Wisconsin  53295
Veterans Affairs Medical Center - Chicago (Lakeside)Chicago, Illinois  60611
Veterans Affairs Medical Center - NashvilleNashville, Tennessee  37212
CCOP - St. Francis Hospital/Natalie Warren Bryant Cancer CenterTulsa, Oklahoma  74136