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Home > "P" Clinical Trials Conditions > Paclitaxel in Treating Patients With Early-Stage Bladder Cancer  Paclitaxel in Treating Patients With Early-Stage Bladder Cancer
Paclitaxel in Treating Patients With Early-Stage Bladder Cancer
For Condition: transitional cell carcinoma of the bladder,stage 1 bladder cancer,stage 0 bladder cancer
Status: Completed
Sponsor(s): West Virginia University ,
Synopsis: 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.
Details: 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. PROTOCOL 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY 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 --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 --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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DonaldLamm, Study Chair, West Virginia University
West Virginia University Hospitals
Morgantown, West Virginia, 26506-9162
United States
Additional Information:
Study ID Numbers: CDR0000065299; WVU-13707-OSP-97-092,NCI-V97-1114
Study Start Date: November 1996
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002917
Other Stage 0 Bladder Cancer Studies:
1. Chemotherapy in Treating Patients With Early-Stage Bladder Cancer
2. Pemetrexed Disodium in Treating Patients With Locally Advanced or Metastatic Recurrent Cancer of the Urothelium
3. Combination Chemotherapy in Treating Patients With Bladder Cancer
4. Fenretinide to Prevent Cancer Recurrence in Treating Patients With Bladder Cancer
5. Cisplatin Plus Gemcitabine With or Without Paclitaxel in Treating Patients With Stage IV Urinary Tract Cancer
Related Studies:
Other stage 0 bladder cancer Clinical Trials
Other West Virginia Clinical Trials
Other Morgantown Clinical Trials
Paclitaxel in Treating Patients With Early-Stage Bladder Cancer
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