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Gemcitabine in Treating Patients With Recurrent or Refractory Bladder Cancer

NCT ID: NCT00014287

Last Updated: 2013-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2000-09-30

Brief Summary

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RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving the drugs in different ways may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of gemcitabine given directly into the bladder in treating patients who have recurrent or refractory bladder cancer.

Detailed Description

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OBJECTIVES: I. Determine the maximum tolerated dose of intravesical gemcitabine in patients with recurrent or refractory superficial bladder cancer. II. Determine the dose-limiting toxicity and other toxic effects of this regimen in these patients. III. Assess any responses in patients treated with this regimen.

OUTLINE: This is a dose-escalation, multicenter study. Patients receive intravesical gemcitabine that is left in the bladder for 2 hours and then removed on day 1. Treatment continues every 7 days for 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of intravesical gemcitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 6 patients experience dose-limiting toxicity. Patients are followed every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 3-36 patients will be accrued for this study.

Conditions

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Bladder Cancer

Keywords

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stage 0 bladder cancer stage I bladder cancer recurrent bladder cancer

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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gemcitabine hydrochloride

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL AST no greater than 2 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL Other: Not pregnant Negative pregnancy test Fertile patients must use effective contraception for 1 week prior to, during, and for at least 2 weeks after study No active bacterial infection requiring treatment with antibiotics

PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics At least 4 weeks since prior immunotherapy Chemotherapy: Prior intravesical chemotherapy allowed At least 4 weeks since prior chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy No prior radiotherapy to bladder Surgery: See Disease Characteristics At least 2 weeks since prior transurethral resection of the bladder/bladder biopsy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

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Laura A. Pollice

Clinical Research Manager

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Donald L. Trump, MD

Role: STUDY_CHAIR

University of Pittsburgh

Countries

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United States

Other Identifiers

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CDR0000068527

Identifier Type: REGISTRY

Identifier Source: secondary_id

LILLY-PCI-99039

Identifier Type: -

Identifier Source: secondary_id

PCI-IRB-990814

Identifier Type: -

Identifier Source: secondary_id

NCI-G01-1926

Identifier Type: -

Identifier Source: secondary_id

99-039

Identifier Type: -

Identifier Source: org_study_id