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Sponsored by: |
National Cancer Institute of Canada |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00352079 |
RATIONALE: Biological therapies, such as BCG, may stimulate the immune system in different ways and stop tumor cells from growing. Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving BCG together with gefitinib may kill more tumor cells. It is not yet known whether BCG is more effective with or without gefitinib in treating bladder cancer.
PURPOSE: This randomized phase III trial is studying BCG and gefitinib to see how well they work compared to BCG alone in treating patients with high-risk bladder cancer.
Condition | Intervention | Phase |
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Bladder Cancer |
Biological: BCG vaccine Drug: gefitinib Procedure: quality-of-life assessment |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control |
Official Title: | A Phase III Study of IRESSA in Combination With Intravesical BCG Versus Intravesical BCG Alone in High Risk Superficial Transitional Cell Carcinoma of the Bladder |
Estimated Enrollment: | 166 |
Study Start Date: | April 2006 |
Estimated Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, prospective, open-label, controlled, multicenter study. Patients are stratified according to study center, status of tumor (primary vs recurrent), carcinoma in situ (yes vs no), prior BCG therapy (yes vs no), and single dose of intravesical mitomycin C at the time of the most recent transurethral resection (yes vs no). Patients are randomized to 1 of 2 treatment arms.
In both arms, treatment with maintenance therapy repeats at 3, 6, 12, 18, 24, 30, and 36 months for a total of 7 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, periodically during study therapy, and then at 3 and 6 months after completion of study therapy.
After study completion, patients are followed every 3 months for 2 years, every 6 months for 4 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 166 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 transitional cell carcinoma (TCC) of the bladder meeting ≥ 1 of the following criteria:
Noninvasive papillary carcinoma (Ta) with ≥ 1 of the following characteristics:
No metastatic disease as confirmed by negative radiology within the past 16 weeks, including the following:
Imaging of the upper urinary tract by 1 of the following methods:
PATIENT CHARACTERISTICS:
Willing to complete quality of life questionnaires in English or French
No significant history of cardiac disease including, but not limited to, any of the following:
PRIOR CONCURRENT THERAPY:
More than 6 months since prior intravesical chemotherapy (including mitomycin C, thiotepa, doxorubicin hydrochloride)
Canada, British Columbia | |
University of British Columbia | |
Vancouver, British Columbia, Canada, V5Z 1M9 | |
Canada, Ontario | |
London Regional Cancer Program at London Health Sciences Centre | |
London, Ontario, Canada, N6A 4L6 | |
McMaster Institute of Urology at St. Joseph Healthcare | |
Hamilton, Ontario, Canada, L8N 4A6 | |
Princess Margaret Hospital | |
Toronto, Ontario, Canada, M5G 2M9 | |
Canada, Quebec | |
Centre Hospitalier Universitaire de Quebec | |
Quebec City, Quebec, Canada, G1R 2J6 | |
CHUS-Hopital Fleurimont | |
Sherbrooke, Quebec, Canada, J1H 5N4 |
Study Chair: | Louis Lacombe, MD | Centre Hospitalier Universitaire de Quebec |
Study ID Numbers: | CDR0000486873, CAN-NCIC-BL11 |
Study First Received: | July 13, 2006 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00352079 History of Changes |
Health Authority: | United States: Federal Government |
transitional cell carcinoma of the bladder stage 0 bladder cancer stage I bladder cancer recurrent bladder cancer |
BCG Vaccine Urinary Tract Neoplasm Cystocele Immunologic Factors Urinary Bladder Diseases Adjuvants, Immunologic Urinary Bladder Neoplasms Urogenital Neoplasms Carcinoma, Transitional Cell |
Urologic Neoplasms Protein Kinase Inhibitors Recurrence Carcinoma Urologic Diseases Bladder Neoplasm Gefitinib Neoplasms, Glandular and Epithelial Transitional Cell Carcinoma |
BCG Vaccine Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Urinary Bladder Diseases Adjuvants, Immunologic Urinary Bladder Neoplasms Enzyme Inhibitors Urogenital Neoplasms |
Carcinoma, Transitional Cell Urologic Neoplasms Protein Kinase Inhibitors Pharmacologic Actions Carcinoma Neoplasms Neoplasms by Site Urologic Diseases Therapeutic Uses Gefitinib Neoplasms, Glandular and Epithelial |