A Phase II Trial of Trastuzumab (Herceptin; NSC #688097, IND #6667) in Patients With Previously Treated Advanced Urothelial Tract Transitional Cell Carcinoma
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Distal Urethral Cancer
- Sponsor
- National Cancer Institute (NCI)
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Objective response rate (complete or partial response) as assessed by RECIST criteria
- Status
- Terminated
- Last Updated
- 13 years ago
Overview
Brief Summary
Phase II trial to study the effectiveness of trastuzumab in treating patients who have previously treated, locally advanced, or metastatic cancer of the urothelium. Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.
Detailed Description
OBJECTIVES: I. Determine the response rate in patients with previously treated, locally advanced or metastatic transitional cell carcinoma of the urothelium treated with trastuzumab (Herceptin). II. Determine the safety of this drug in this patient population. III. Determine overall and progression-free survival of this patient population treated with this drug. OUTLINE: Patients receive a loading dose of trastuzumab (Herceptin) IV over 90 minutes on day 1 of week 1. For all subsequent doses, patients receive trastuzumab IV over 30 minutes weekly. Treatment may continue for more than 1 year in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months for 1 year and then every 6 months thereafter.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Histologically confirmed transitional cell carcinoma (TCC) of the urothelium, including the bladder, urethra, ureter, or renal pelvis
- •No pure adenocarcinomas, pure squamous cell carcinomas, small cell carcinoma, or only small foci of TCC (less than 10% of tumor specimen)
- •Locally advanced (T4b) TCC of the bladder
- •Metastatic (N2 or N3 or M1)TCC of the urothelium
- •HER2 expression (3+) as determined by immunohistochemistry or gene amplification by fluorescent in situ hybridization
- •Must not be a candidate for potentially curative surgery or radiotherapy
- •Measurable disease
- •At least 1 unidimensionally measurable lesion of at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
- •The following lesions are considered nonmeasurable:
- •Bone lesions
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Objective response rate (complete or partial response) as assessed by RECIST criteria
Time Frame: 1 year
Secondary Outcomes
- Overall survival (OS)(From date of initiation of treatment to date of death due to any cause, assessed up to 1 year)
- Disease-free survival (DFS)(From date of initiation of treatment to date of progression or death due to any cause, whichever occurs first, assessed up to 1 year)
- Toxicities as graded according to the NCI Common Toxicity Criteria(12 weeks)
- Proportion of patients who are HER2 positive (3+ by IHC or FISH positive)(Baseline)