Paclitaxel and Radiation Therapy With or Without Trastuzumab in Treating Patients Who Have Undergone Surgery for Bladder Cancer

Completed · Phase 1/Phase 2

Conditions studied: Bladder Urothelial Carcinoma, Stage I Bladder Cancer AJCC v6 and v7, Stage II Bladder Cancer AJCC v6 and v7, Stage III Bladder Cancer AJCC v6 and v7

In brief

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. 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.

Key facts

Study ID

NCT00238420

Run by

National Cancer Institute (NCI)

People needed

70

Starts

2005-07-26

Expected to finish

2022-05-20

Last updated by the study team

2022-07-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically or cytologically confirmed primary transitional cell carcinoma (TCC) of the bladder
• Histologic evidence of muscularis propria invasion
• Meets 1 of the following stage criteria:
• Stage T2-4a; NX, N0, or N1; and M0 disease
• Clinical stage T1, grade 3/3 disease AND requires definitive local therapy
• Tumor involvement of the prostatic urethra allowed provided the following criteria are met:
• Tumor was visibly completely resected
• No evidence of stromal invasion of the prostate
• No evidence of distant metastases by chest x-ray (or chest CT scan) within 8 weeks prior to registration
• No evidence of distant metastases by abdominal/pelvic CT scan (or MRI scan) within 8 weeks prior to registration
• Has undergone transurethral bladder resection (as thorough as is judged safely possible) within the past 3-8 weeks, including bimanual examination with tumor mapping
• Sufficient tumor tissue available for HER2/neu analysis
• Not a candidate for radical cystectomy
• Performance status - Zubrod 0-2
• Absolute neutrophil count >= 1,800/mm\^3
• Platelet count >= 100,000/mm\^3
• Hemoglobin >= 8.0 g/dL (transfusion or other intervention allowed)
• Bilirubin < 2.0 mg/dL
• Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamate pyruvate transaminase (SGPT) < 2.5 times upper limit of normal
• No hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
• Creatinine =< 3.0 mg/dL
• Left ventricular ejection fraction (LVEF) >= 40% by multigated acquisition scan (MUGA) scan or echocardiogram
• No unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months
• No transmural myocardial infarction within the past 6 months
• Not pregnant or nursing

Where it is running

• Providence Alaska Medical Center — Anchorage, Alaska, United States
• Sutter Cancer Centers Radiation Oncology Services-Auburn — Auburn, California, United States
• Providence Saint Joseph Medical Center/Disney Family Cancer Center — Burbank, California, United States
• Sutter Cancer Centers Radiation Oncology Services-Cameron Park — Cameron Park, California, United States
• Mercy San Juan Medical Center — Carmichael, California, United States
• Sutter Cancer Centers Radiation Oncology Services-Roseville — Roseville, California, United States
• Sutter Medical Center Sacramento — Sacramento, California, United States
• Mercy General Hospital Radiation Oncology Center — Sacramento, California, United States
• Sutter Cancer Centers Radiation Oncology Services-Vacaville — Vacaville, California, United States
• Penrose-Saint Francis Healthcare — Colorado Springs, Colorado, United States
• The Reverend Roger Patrick Dorcy Cancer Center at Saint Mary-Corwin Medical Center — Pueblo, Colorado, United States
• Beebe Medical Center — Lewes, Delaware, United States
• Christiana Care Health System-Christiana Hospital — Newark, Delaware, United States
• Saint Francis Hospital - Wilmington — Wilmington, Delaware, United States
• MedStar Georgetown University Hospital — Washington D.C., District of Columbia, United States
• Holy Cross Hospital — Fort Lauderdale, Florida, United States
• University of Florida Health Science Center - Jacksonville — Jacksonville, Florida, United States
• Jupiter Medical Center — Jupiter, Florida, United States
• University of Miami Miller School of Medicine-Sylvester Cancer Center — Miami, Florida, United States
• Mount Sinai Medical Center — Miami Beach, Florida, United States
• Orlando Health Cancer Institute — Orlando, Florida, United States
• Bay Medical Center — Panama City, Florida, United States
• Rush - Copley Medical Center — Aurora, Illinois, United States
• Saint Joseph Medical Center — Bloomington, Illinois, United States
• Mobile Infirmary Medical Center — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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