Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Trastuzumab and Combination Chemotherapy in Treating Patients With Locally Recurrent or Metastatic Urinary Tract Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	18 and over	NCI	CCUM-9955 WSU-C-2078, NCI-198, NCT00005831, 198

Objectives

1. Determine the toxicity of the combination of trastuzumab (Herceptin), paclitaxel, carboplatin, and gemcitabine in patients with HER2-overexpressing locally recurrent or metastatic urothelial carcinoma.
2. Determine the complete and partial response rates in patients treated with this regimen.
3. Determine the median and overall survival of patients treated with this regimen.

Entry Criteria

Disease Characteristics:

• Histologically confirmed locally recurrent or metastatic urothelial carcinoma incurable by surgery or radiotherapy
  • Transitional cell OR squamous cell




• HER2 overexpression of the primary or metastatic site evidenced by 1 of the following:
  • 2+ or 3+ staining by immunohistochemistry
  • Positive FISH defined as greater than 2 with the Vysis system or greater than 4 with the Ventana system
  • Elevated serum HER2 greater than 16 ng/mL with the OSDI assay



• Biopsy-proven HER2 overexpression of metastatic site if primary site is histologically and serologically HER2 negative*



• Bidimensionally measurable or evaluable disease
  • Disease outside previously irradiated fields

 [Note: *HER2-negative patients are not eligible for treatment but are followed for response and survival]

Prior/Concurrent Therapy:

Biologic therapy:

• Not specified

Chemotherapy:

• No prior systemic chemotherapy for metastatic disease
• At least 6 months since prior adjuvant chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• See Disease Characteristics
• At least 4 weeks since prior radiotherapy and recovered

Surgery:

• See Disease Characteristics

Patient Characteristics:

Age:

• 18 and over

Performance status:

• SWOG 0-2

Life expectancy:

• More than 12 weeks

Hematopoietic:

• Granulocyte count greater than 1,500/mm³
• Platelet count at least 100,000/mm³

Hepatic:

• Bilirubin no greater than 1.5 mg/dL

Renal:

• Creatinine no greater than 2.0 mg/dL

Cardiovascular:

• No significant cardiac disease
• Ejection fraction at least 50% by MUGA or 2D echocardiogram
• No evidence of symptomatic coronary artery disease
• No active ischemia on EKG
• No history of congestive heart failure

Other:

• No active bacterial infection
• No other prior malignancy except adequately treated basal or squamous cell skin cancer or carcinoma in situ
• HIV negative
• Not pregnant or nursing
• Fertile patients must use effective contraception

Expected Enrollment

A total of 40 patients will be accrued for this study within 24 months.

Outline

Patients receive trastuzumab (Herceptin) IV over 30-90 minutes on days 1, 8, and 15; paclitaxel IV over 3 hours and carboplatin IV over 15 minutes on day 1; and gemcitabine IV over 30 minutes on days 1 and 8. Courses repeat every 3 weeks. Patients achieving a complete response (CR) receive 3 courses past CR. Patients achieving a partial response or stable disease continue on therapy until CR or disease progression or unacceptable toxicity.

Patients are followed for disease progression and survival. Patients with HER2-negative disease are not eligible for treatment but are followed every 6 months for response and survival.

Hussain MH, MacVicar GR, Petrylak DP, et al.: Trastuzumab, paclitaxel, carboplatin, and gemcitabine in advanced human epidermal growth factor receptor-2/neu-positive urothelial carcinoma: results of a multicenter phase II National Cancer Institute trial. J Clin Oncol 25 (16): 2218-24, 2007.[PUBMED Abstract]

Hussain M, Petrylak D, Dunn R, et al.: Trastuzumab (T), paclitaxel (P), carboplatin (C), and gemcitabine (G) in advanced HER2- positive urothelial carcinoma: results of a multi-center phase II NCI trial. [Abstract] J Clin Oncol 23 (Suppl 16): A-4507, 379s, 2005.

Trial Contact Information

Trial Lead Organizations

University of Michigan Comprehensive Cancer Center

Maha Hadi Hussain, MD, Protocol chair		Ph: 734-936-8906; 800-865-1125

Registry Information
Official Title		Phase II Evaluation of Trastuzumab (Herceptin), Paclitaxel, Carboplatin, and Gemcitabine in the Treatment of Advanced Urothelial Cancer
Trial Start Date		2000-12-14
Trial Completion Date		2004-08-26
Registered in ClinicalTrials.gov		NCT00005831
Date Submitted to PDQ		2000-04-05
Information Last Verified		2004-08-26
NCI Grant/Contract Number		CA22453

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