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Study 20 of 2072 for search of: | United States, Utah |
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Sponsors and Collaborators: |
Radiation Therapy Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00238420 |
RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Paclitaxel may also make tumor cells more sensitive to radiation therapy. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving paclitaxel together with radiation therapy and trastuzumab may kill more tumor cells. Giving these treatments after surgery may kill any remaining tumor cells.
PURPOSE: This phase I/II trial is studying the side effects of giving paclitaxel together with radiation therapy with or without trastuzumab and to see how well it works to kill any remaining tumor cells in patients who have undergone surgery for bladder cancer.
Condition | Intervention | Phase |
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Bladder Cancer |
Drug: paclitaxel Drug: trastuzumab Procedure: radiation therapy |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized |
Official Title: | A Phase I/II Trial of a Combination of Paclitaxel and Trastuzumab With Daily Irradiation or Paclitaxel Alone With Daily Irradiation Following Transurethral Surgery for Non-Cystectomy Candidates With Muscle-Invasive Bladder Cancer |
Estimated Enrollment: | 88 |
Study Start Date: | July 2005 |
Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Group 1: Experimental
Patients receive paclitaxel IV over 1 hour on days 1, 8, 15, 22, 29, 36, and 43 and trastuzumab (Herceptin®) IV over 90 minutes on day 1 and then over 30 minutes on days 8, 15, 22, 29, 36, and 43. Patients also undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, 43-47, and 50. Treatment continues in the absence of disease progression or unacceptable toxicity.
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Drug: paclitaxel
Given IV
Drug: trastuzumab
Given IV
Procedure: radiation therapy
Given once daily
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Group 2: Experimental
Patients receive paclitaxel and undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, 43-47, and 50.
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Drug: paclitaxel
Given IV
Procedure: radiation therapy
Given once daily
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OBJECTIVES:
Primary
Secondary
OUTLINE: This is a non-randomized, multicenter study. Patients are assigned to 1 of 2 treatment groups according to HER2/neu status (HER2/neu 2+ or 3+ staining [group 1] vs HER2/neu 0 or 1+ staining [group 2]).
PROJECTED ACCRUAL: A total of 88 patients (44 per treatment group) will be accrued for this study within approximately 3 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed primary transitional cell carcinoma (TCC) of the bladder within the past 12 weeks
Meets 1 of the following stage criteria:
Tumor involvement of the prostatic urethra allowed provided the following criteria are met:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Study Chair: | M. Dror Michaelson, MD, PhD | Massachusetts General Hospital |
Investigator: | Alan Pollack, MD, PhD | Fox Chase Cancer Center |
Investigator: | Douglas M. Dahl, MD | Massachusetts General Hospital |
Study ID Numbers: | CDR0000440988, RTOG-0524 |
Study First Received: | October 12, 2005 |
Last Updated: | January 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00238420 |
Health Authority: | Unspecified |
stage I bladder cancer transitional cell carcinoma of the bladder stage II bladder cancer stage III bladder cancer |
Cystocele Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Neoplasms Carcinoma, Transitional Cell Urologic Neoplasms Transitional cell carcinoma |
Carcinoma Urologic Diseases Paclitaxel Trastuzumab Urinary tract neoplasm Bladder neoplasm |
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses |
Mitosis Modulators Tubulin Modulators Antimitotic Agents Antineoplastic Agents, Phytogenic Pharmacologic Actions |