Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Related Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II, Phase I	Treatment	Temporarily closed	18 and over	NCI	RTOG-0524 NCT00238420

Special Category: NCI Web site featured trial

Objectives

Primary

1. Determine the acute toxicity of paclitaxel and radiotherapy with or without trastuzumab (Herceptin®) in patients who have undergone prior transurethral bladder resection for muscle-invasive transitional cell carcinoma of the bladder.

Secondary

1. Determine the ability of these patients to complete these regimens.
2. Determine the efficacy of these regimens, in terms of achieving a complete response of the primary tumor, in these patients.
3. Determine the 5-year disease-free and overall survival of patients treated with these regimens.
4. Determine the value of tumor and/or serum biomarkers as predictors of initial tumor response and recurrence-free survival of patients treated with these regimens.

Entry Criteria

Disease Characteristics:

• Histologically or cytologically confirmed primary transitional cell carcinoma (TCC) of the bladder within the past 12 weeks
  • 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 CT scan AND abdominal/pelvic CT scan



• 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

Prior/Concurrent Therapy:

Biologic therapy

• Not specified

Chemotherapy

• No prior systemic chemotherapy with anthracyclines or taxanes
• No prior systemic chemotherapy for TCC

Endocrine therapy

• Not specified

Radiotherapy

• No prior pelvic radiotherapy

Surgery

• See Disease Characteristics

Patient Characteristics:

Age

• 18 and over

Performance status

• Zubrod 0-2

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count ≥ 1,800/mm³
• Platelet count ≥ 100,000/mm³
• Hemoglobin ≥ 8.0 g/dL (transfusion or other intervention allowed)

Hepatic

• Bilirubin < 2.0 mg/dL
• SGOT and SGPT < 2.5 times upper limit of normal
• No hepatic insufficiency resulting in clinical jaundice and/or coagulation defects

Renal

• Creatinine ≤ 3.0 mg/dL

Cardiovascular

• LVEF ≥ 40% by 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

Other

• 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

Expected Enrollment

A total of 88 patients (44 per treatment group) will be accrued for this study within approximately 3 years.

Outcomes

Safety during weekly treatment

Complete response rate by cystoscopy at 12 weeks

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]).

• Group 1: 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.



• Group 2: Patients receive paclitaxel and undergo radiotherapy as in group 1.

After completion of study treatment, patients are followed at 4-5 weeks, every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.

Trial Contact Information

Trial Lead Organizations

Radiation Therapy Oncology Group

M. Dror Michaelson, MD, PhD, Protocol chair		Ph: 617-726-1594; 877-726-5130
Alan Pollack, MD, PhD, Protocol co-chair		Ph: 215-728-2940; 888-369-2427 Email: alan.pollack@fccc.edu
Douglas Dahl, MD, Protocol co-chair		Ph: 617-726-0874; 877-726-5130 Email: ddahl@partners.org

Related Information

Featured trial article

Registry Information
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
Trial Start Date		2005-07-26
Trial Completion Date		2012-07-15 (estimated)
Registered in ClinicalTrials.gov		NCT00238420
Date Submitted to PDQ		2005-07-12
Information Last Verified		2009-06-06
NCI Grant/Contract Number		CA21661

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