NCT00002914

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 1997

Longer than P75 for phase_2

Geographic Reach
2 countries

29 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 15, 1997

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2001

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2004

Completed
5 months until next milestone

First Posted

Study publicly available on registry

August 11, 2004

Completed
Last Updated

June 22, 2023

Status Verified

June 1, 2023

Enrollment Period

3.9 years

First QC Date

November 1, 1999

Last Update Submit

June 20, 2023

Conditions

Bladder CancerTransitional Cell Cancer of the Renal Pelvis and UreterUrethral Cancer

Keywords

recurrent bladder cancertransitional cell carcinoma of the bladdersquamous cell carcinoma of the bladderadenocarcinoma of the bladderrecurrent urethral cancerrecurrent transitional cell cancer of the renal pelvis and ureter

Interventions

piritreximDRUG

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

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

Sponsors & Collaborators

Study Sites (29)

Emory University Hospital - Atlanta

Atlanta, Georgia, 30322, United States

Location

Veterans Affairs Medical Center - Atlanta (Decatur)

Decatur, Georgia, 30033, United States

Location

Robert H. Lurie Comprehensive Cancer Center, Northwestern University

Chicago, Illinois, 60611, United States

Location

Veterans Affairs Medical Center - Chicago (Lakeside)

Chicago, Illinois, 60611, United States

Location

CCOP - Illinois Oncology Research Association

Peoria, Illinois, 61602, United States

Location

CCOP - Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

Indiana University Cancer Center

Indianapolis, Indiana, 46202-5265, United States

Location

Veterans Affairs Medical Center - Indianapolis (Roudebush)

Indianapolis, Indiana, 46202, United States

Location

CCOP - Cedar Rapids Oncology Project

Cedar Rapids, Iowa, 52403-1206, United States

Location

CCOP - Iowa Oncology Research Association

Des Moines, Iowa, 10309-1016, United States

Location

CCOP - Kalamazoo

Kalamazoo, Michigan, 49007-3731, United States

Location

CCOP - Metro-Minnesota

Saint Louis Park, Minnesota, 55416, United States

Location

Veterans Affairs Medical Center - East Orange

East Orange, New Jersey, 07018-1095, United States

Location

CCOP - Northern New Jersey

Hackensack, New Jersey, 07601, United States

Location

University of Rochester Cancer Center

Rochester, New York, 14642, United States

Location

Albert Einstein Comprehensive Cancer Center

The Bronx, New York, 10461, United States

Location

CCOP - Merit Care Hospital

Fargo, North Dakota, 58122, United States

Location

Ireland Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

Cleveland Clinic Cancer Center

Cleveland, Ohio, 44195, United States

Location

CCOP - Toledo Community Hospital Oncology Program

Toledo, Ohio, 43623-3456, United States

Location

CCOP - St. Francis Hospital/Natalie Warren Bryant Cancer Center

Tulsa, Oklahoma, 74136, United States

Location

CCOP - Geisinger Clinical and Medical Center

Danville, Pennsylvania, 17822-2001, United States

Location

Veterans Affairs Medical Center - Nashville

Nashville, Tennessee, 37212, United States

Location

Vanderbilt Cancer Center

Nashville, Tennessee, 37232-6838, United States

Location

Veterans Affairs Medical Center - Madison

Madison, Wisconsin, 53705, United States

Location

University of Wisconsin Comprehensive Cancer Center

Madison, Wisconsin, 53792, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Veterans Affairs Medical Center - Milwaukee (Zablocki)

Milwaukee, Wisconsin, 53295, United States

Location

Pretoria Academic Hospital

Pretoria, 0001, South Africa

Location

Related 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):425-9. doi: 10.1023/a:1020675017737.

    PMID: 12448661RESULT

MeSH Terms

Conditions

Urinary Bladder NeoplasmsUrethral Neoplasms

Interventions

piritrexim

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital DiseasesUrethral Diseases

Study Officials

  • Bruce J. Roth, MD

    Vanderbilt-Ingram Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
NETWORK

Study Record Dates

First Submitted

November 1, 1999

First Posted

August 11, 2004

Study Start

July 15, 1997

Primary Completion

June 1, 2001

Study Completion

March 1, 2004

Last Updated

June 22, 2023

Record last verified: 2023-06

Locations

US(28)ZA(1)