CompletedPhase 1/2

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

United States70 participantsStarted 2005-07-26

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 ventricula…

What they're measuring

Acute Treatment-related Toxicity

Timeframe: From start of protocol treatment to 90 days

Trial details

NCT IDNCT00238420

SponsorNational Cancer Institute (NCI)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2014-02-05

Results submitted2015-12-10