Paclitaxel in Treating Patients With Early-Stage Bladder Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00002917
Recruitment Status : Completed
First Posted : May 26, 2004
Last Update Posted : May 15, 2013
Information provided by:
National Cancer Institute (NCI)

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.

Condition or disease Intervention/treatment Phase
Bladder Cancer Drug: paclitaxel Phase 1 Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Study Start Date : November 1996
Actual Study Completion Date : May 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer
Drug Information available for: Paclitaxel

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00002917

United States, West Virginia
West Virginia University Hospitals
Morgantown, West Virginia, United States, 26506-9162
Sponsors and Collaborators
Mary Babb Randolph Cancer Center at West Virginia University Hospitals
Study Chair: Donald L. Lamm, MD Mayo Clinic Identifier: NCT00002917     History of Changes
Other Study ID Numbers: WVU-13707-OSP-97-092
CDR0000065299 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: May 26, 2004    Key Record Dates
Last Update Posted: May 15, 2013
Last Verified: January 2001

Keywords provided by National Cancer Institute (NCI):
stage 0 bladder cancer
stage I bladder cancer
transitional cell carcinoma of the bladder

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action