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Sponsors and Collaborators: |
Eastern Cooperative Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003129 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of chemotherapy in treating patients with early-stage bladder cancer that has not responded to BCG therapy.
Condition | Intervention | Phase |
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Bladder Cancer |
Drug: valrubicin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase II Study of Intravesical Therapy With AD 32 in Patients With Papillary Urothelial Carcinoma or Carcinoma in Situ (CIS) Refractory to Prior Therapy With Bacillus Calmette-Guerin |
Estimated Enrollment: | 75 |
Study Start Date: | July 1998 |
Primary Completion Date: | November 2002 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: Patients are stratified according to cellular diagnosis (papillary transitional cell carcinoma (Ta/T1) with no carcinoma in situ (Tis) vs Tis with or without Ta/T1).
Patients receive intravesical AD 32 once a week for 6 weeks.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 75 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed recurrent superficial bladder cancer defined as papillary transitional cell carcinoma (stage Ta/T1) and/or carcinoma in situ (stage Tis) of the urinary bladder
Must meet 1 of the following criteria:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
United States, Florida | |
H. Lee Moffitt Cancer Center and Research Institute | |
Tampa, Florida, United States, 33612-9497 | |
United States, Illinois | |
CCOP - Carle Cancer Center | |
Urbana, Illinois, United States, 61801 | |
United States, New Jersey | |
Veterans Affairs Medical Center - East Orange | |
East Orange, New Jersey, United States, 07018-1095 | |
United States, Pennsylvania | |
CCOP - MainLine Health | |
Wynnewood, Pennsylvania, United States, 19096 | |
Fox Chase Cancer Center | |
Philadelphia, Pennsylvania, United States, 19111 | |
United States, Wisconsin | |
Veterans Affairs Medical Center - Milwaukee (Zablocki) | |
Milwaukee, Wisconsin, United States, 53295 | |
Medical College of Wisconsin | |
Milwaukee, Wisconsin, United States, 53226 | |
University of Wisconsin Comprehensive Cancer Center | |
Madison, Wisconsin, United States, 53792-6164 | |
Veterans Affairs Medical Center - Madison | |
Madison, Wisconsin, United States, 53705 | |
CCOP - Green Bay | |
Green Bay, Wisconsin, United States, 54301 |
Study Chair: | Jeffrey M. Ignatoff, MD | NorthShore University HealthSystem Research Institute |
Study ID Numbers: | CDR0000065892, E-3897 |
Study First Received: | November 1, 1999 |
Last Updated: | June 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00003129 History of Changes |
Health Authority: | United States: Federal Government |
stage 0 bladder cancer stage I bladder cancer transitional cell carcinoma of the bladder |
BCG Vaccine Urinary Tract Neoplasm Cystocele Valrubicin Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Neoplasms |
Carcinoma, Transitional Cell Urologic Neoplasms Carcinoma Urologic Diseases Carcinoma in Situ Bladder Neoplasm Transitional Cell Carcinoma |
Neoplasms Neoplasms by Site Urologic Diseases Antineoplastic Agents Therapeutic Uses Valrubicin |
Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Neoplasms Urologic Neoplasms Pharmacologic Actions |