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Paclitaxel in Treating Patients With Early-Stage Bladder Cancer

Primary Purpose

Bladder Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
paclitaxel
Sponsored by
Mary Babb Randolph Cancer Center at West Virginia University Hospitals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bladder Cancer focused on measuring stage 0 bladder cancer, stage I bladder cancer, transitional cell carcinoma of the bladder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically proven CIS and/or unresectable/residual superficial bladder tumor (pTa G1-G3 to pT1 G1-G3) -confirmed by biopsy, bladder mapping, or positive cytology Cystoscopic examination and bladder mapping must be performed within 6 weeks of study PATIENT CHARACTERISTICS: Age: 18 and over Performance Status: Karnofsky of 60 to 100% Life Expectancy: Not specified Hematopoietic: Hemoglobin greater than 11 g/dL WBC greater than 4500/mm3 Neutrophils greater than 1500/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin, AST, and ALT no greater than 2.5 x normal Renal: Creatinine no greater than 2.5 x normal Cardiovascular: No concurrent cardiovascular disease Other: No active infection requiring concurrent therapy Not pregnant or nursing No upper renal tract disease No concurrent malignancy except for basal or squamous cell skin cancer or noninvasive cancer of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: No intravesical BCG within 3 months prior to study entry Prior BCG therapy is required for CIS patients (if not contraindicated) Chemotherapy: No prior intravesical chemotherapy within 4 weeks prior to study No prior systemic anticancer therapy within 4 months prior to study No prior paclitaxel therapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy within 4 months prior to study Surgery: Not specified Other: No hypersensitivity reactions to products containing cremophor

Sites / Locations

  • West Virginia University Hospitals

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
May 14, 2013
Sponsor
Mary Babb Randolph Cancer Center at West Virginia University Hospitals
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1. Study Identification

Unique Protocol Identification Number
NCT00002917
Brief Title
Paclitaxel in Treating Patients With Early-Stage Bladder Cancer
Official Title
A PHASE I/II INSTITUTIONAL STUDY OF INTRAVESICAL TAXOL (PACLITAXEL) INSTILLATION FOR THE TREATMENT OF SUPERFICIAL BLADDER CANCER
Study Type
Interventional

2. Study Status

Record Verification Date
January 2001
Overall Recruitment Status
Completed
Study Start Date
November 1996 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Mary Babb Randolph Cancer Center at West Virginia University Hospitals

4. Oversight

5. 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 I/II trial to study the effectiveness of paclitaxel in treating patients with early-stage bladder cancer.
Detailed Description
OBJECTIVES: I. Evaluate toxicity and safety of intravesical paclitaxel in patients with superficial bladder cancer. II. Evaluate the efficacy of paclitaxel against transitional cell carcinoma in situ (CIS) and/or unresectable papillary superficial bladder cancer. III. Evaluate a dose-response effect and choose an appropriate dose for further clinical study. OUTLINE: Cohorts of patients receive intravesical paclitaxel in escalating doses, administered twice weekly for 6 weeks, then once every 2 weeks for another 6 weeks, for a maximum of 2 courses at a dose level. Patients must complete 8 of the first 15 instillations and a 3 month cystoscopic exam with biopsy and cytology to be deemed evaluable. Participants are followed by quarterly cytoscopy and cytology for an additional 21 month period. Biopsies are performed at 3 and/or 6 months, and thereafter if clinically applicable. PROJECTED ACCRUAL: 19 evaluable patients will be enrolled.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer
Keywords
stage 0 bladder cancer, stage I bladder cancer, transitional cell carcinoma of the bladder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
paclitaxel

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically proven CIS and/or unresectable/residual superficial bladder tumor (pTa G1-G3 to pT1 G1-G3) -confirmed by biopsy, bladder mapping, or positive cytology Cystoscopic examination and bladder mapping must be performed within 6 weeks of study PATIENT CHARACTERISTICS: Age: 18 and over Performance Status: Karnofsky of 60 to 100% Life Expectancy: Not specified Hematopoietic: Hemoglobin greater than 11 g/dL WBC greater than 4500/mm3 Neutrophils greater than 1500/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin, AST, and ALT no greater than 2.5 x normal Renal: Creatinine no greater than 2.5 x normal Cardiovascular: No concurrent cardiovascular disease Other: No active infection requiring concurrent therapy Not pregnant or nursing No upper renal tract disease No concurrent malignancy except for basal or squamous cell skin cancer or noninvasive cancer of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: No intravesical BCG within 3 months prior to study entry Prior BCG therapy is required for CIS patients (if not contraindicated) Chemotherapy: No prior intravesical chemotherapy within 4 weeks prior to study No prior systemic anticancer therapy within 4 months prior to study No prior paclitaxel therapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy within 4 months prior to study Surgery: Not specified Other: No hypersensitivity reactions to products containing cremophor
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donald L. Lamm, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Study Chair
Facility Information:
Facility Name
West Virginia University Hospitals
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506-9162
Country
United States

12. IPD Sharing Statement

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Paclitaxel in Treating Patients With Early-Stage Bladder Cancer

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