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Status:

COMPLETED

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

Lead Sponsor:

National Cancer Institute (NCI)

Collaborating Sponsors:

Radiation Therapy Oncology Group

Conditions:

Bladder Urothelial Carcinoma

Stage I Bladder Cancer AJCC v6 and v7

Eligibility:

All Genders

18+ years

Phase:

PHASE1

PHASE2

Brief 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 pa...

Detailed Description

PRIMARY OBJECTIVES: I. To determine the acute toxicity (=\< 90 days from protocol treatment start) from chemoradiotherapy including paclitaxel +/- trastuzumab and irradiation in non-cystectomy patien...

Eligibility Criteria

Inclusion

  • 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 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
  • No nursing for 6 months after completion of study treatment (for patients receiving trastuzumab \[Herceptin®\])
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 6 months after completion of study treatment
  • Able to tolerate systemic chemotherapy and pelvic radiotherapy
  • No other invasive malignancy within the past 3 years except nonmelanoma skin cancer
  • No history of allergic reaction to study drugs
  • No history of inflammatory bowel disease
  • No acute bacterial or fungal infection requiring IV antibiotics
  • No AIDS
  • No other severe active comorbidity
  • No prior systemic chemotherapy with anthracyclines or taxanes
  • No prior systemic chemotherapy for TCC
  • No prior pelvic radiotherapy

Exclusion

    Key Trial Info

    Start Date :

    July 26 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    May 20 2022

    Estimated Enrollment :

    70 Patients enrolled

    Trial Details

    Trial ID

    NCT00238420

    Start Date

    July 26 2005

    End Date

    May 20 2022

    Last Update

    July 19 2022

    Active Locations (184)

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    Page 1 of 46 (184 locations)

    1

    Mobile Infirmary Medical Center

    Mobile, Alabama, United States, 36607

    2

    Providence Alaska Medical Center

    Anchorage, Alaska, United States, 99508

    3

    Sutter Cancer Centers Radiation Oncology Services-Auburn

    Auburn, California, United States, 95603

    4

    Providence Saint Joseph Medical Center/Disney Family Cancer Center

    Burbank, California, United States, 91505