Bladder Cancer Clinical Trial
Official title:
A PHASE I/II INSTITUTIONAL STUDY OF INTRAVESICAL TAXOL (PACLITAXEL) INSTILLATION FOR THE TREATMENT OF SUPERFICIAL BLADDER CANCER
Verified date | January 2001 |
Source | National Cancer Institute (NCI) |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 0 |
Est. completion date | May 2004 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | West Virginia University Hospitals | Morgantown | West Virginia |
Lead Sponsor | Collaborator |
---|---|
Mary Babb Randolph Cancer Center at West Virginia University Hospitals |
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