Bladder CancerPhase 2NCT00002914
Piritrexim in Treating Patients With Advanced Cancer of the Urinary Tract
A Phase 2 study testing piritrexim in people with Bladder Cancer and Transitional Cell Cancer of the Renal Pelvis and Ureter, run by Eastern Cooperative Oncology Group at 29 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Bladder Cancer, Transitional Cell Cancer of the Renal Pelvis and Ureter, Urethral Cancer
- What is being tested?
- piritrexim
- How many people
- 40 participants
- Where
- 29 sitesin 2 countries
- Study dates
- 15 Jul 1997to Mar 2004
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
29 sites in 2 countries.
29 sites in 2 countries
United States28 sites
Emory University Hospital - Atlanta
Atlanta, Georgia, 30322
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, 52403-1206
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, 60611
Veterans Affairs Medical Center - Chicago (Lakeside)
Chicago, Illinois, 60611
Ireland Cancer Center
Cleveland, Ohio, 44106-5065
Cleveland Clinic Cancer Center
Cleveland, Ohio, 44195
CCOP - Geisinger Clinical and Medical Center
Danville, Pennsylvania, 17822-2001
Veterans Affairs Medical Center - Atlanta (Decatur)
Decatur, Georgia, 30033
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, 10309-1016
Veterans Affairs Medical Center - East Orange
East Orange, New Jersey, 07018-1095
CCOP - Merit Care Hospital
Fargo, North Dakota, 58122
CCOP - Northern New Jersey
Hackensack, New Jersey, 07601
Indiana University Cancer Center
Indianapolis, Indiana, 46202-5265
Veterans Affairs Medical Center - Indianapolis (Roudebush)
Indianapolis, Indiana, 46202
CCOP - Kalamazoo
Kalamazoo, Michigan, 49007-3731
Veterans Affairs Medical Center - Madison
Madison, Wisconsin, 53705
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Veterans Affairs Medical Center - Milwaukee (Zablocki)
Milwaukee, Wisconsin, 53295
Veterans Affairs Medical Center - Nashville
Nashville, Tennessee, 37212
Vanderbilt Cancer Center
Nashville, Tennessee, 37232-6838
CCOP - Illinois Oncology Research Association
Peoria, Illinois, 61602
University of Rochester Cancer Center
Rochester, New York, 14642
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, 55416
Albert Einstein Comprehensive Cancer Center
The Bronx, New York, 10461
CCOP - Toledo Community Hospital Oncology Program
Toledo, Ohio, 43623-3456
CCOP - St. Francis Hospital/Natalie Warren Bryant Cancer Center
Tulsa, Oklahoma, 74136
CCOP - Carle Cancer Center
Urbana, Illinois, 61801
About this study
Official title: PHASE II STUDY OF PIRITREXIM IN ADVANCED CARCINOMA OF THE UROTHELIUM
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.
Read the 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.
- Being tested
- piritrexim
- Keywords
- 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
- Medical subject headings
- Urinary Bladder Neoplasms, Urethral Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
piritreximDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2004 (estimated)
- Study start15 Jul 1997
- Primary completionJun 2001
- Study completionMar 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eastern Cooperative Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Bruce J. Roth, MD, Study chair, Vanderbilt-Ingram Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002914
- Sponsor's protocol ID
- CDR0000065289
- Other IDs
- E-3896
- Status last verified
- Jun 2023
- First submitted
- 1 Nov 1999
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 12448661
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PHASE II STUDY OF PIRITREXIM IN ADVANCED CARCINOMA OF THE UROTHELIUM
- ClinicalTrials.gov ID
- NCT00002914
- Acronym / sponsor ID
- CDR0000065289
- Keywords
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Eastern Cooperative Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 15 Jul 1997 (actual)
- Primary completion
- Jun 2001 (actual)
- Study completion
- Mar 2004 (actual)
- First posted
- 11 Aug 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| piritrexim | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Results publication: PubMed 12448661Roth 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruce J. Roth, MD study chair
Vanderbilt-Ingram Cancer Center
29 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing piritrexim in people with Bladder Cancer and Transitional Cell Cancer of the Renal Pelvis and Ureter, run by Eastern Cooperative Oncology Group at 29 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in United States, South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00002914, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.