Status:
COMPLETED
Erlotinib Before and After Surgery in Treating Patients With Muscle-Invasive Bladder Cancer
Lead Sponsor:
UNC Lineberger Comprehensive Cancer Center
Collaborating Sponsors:
OSI Pharmaceuticals
National Cancer Institute (NCI)
Conditions:
Bladder Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving erlotinib before surgery may make the tumor smaller and reduce the amount of norm...
Detailed Description
OBJECTIVES: Primary * Determine the effect of neoadjuvant erlotinib hydrochloride on histopathological, molecular, and genetic correlates in patients undergoing radical cystectomy for muscle-invasiv...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed muscle-invasive bladder cancer, meeting the following criteria:
- Clinical stage T2 disease
- No locally-extensive clinical stage T3 or T4 disease
- No metastatic disease (N+, M+) by physical exam or radiologic evaluation
- Must have undergone prior initial or confirmatory transurethral resection of the bladder tumor (TURBT)
- Candidate for and has agreed to undergo radical cystectomy with curative intent
- No non-transitional cell carcinoma histologies
- PATIENT CHARACTERISTICS:
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Granulocyte count \> 1,500/mm³
- Platelet count \> 100,000/mm³
- Bilirubin normal
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 2 times upper limit of normal
- Creatinine normal
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No contraindication to erlotinib hydrochloride or other tyrosine kinase inhibitors
- PRIOR CONCURRENT THERAPY:
- No prior radiotherapy or systemic chemotherapy for bladder cancer
- Prior single-dose mitomycin C allowed at the time of TURBT
- Prior 6- or 12-week course of adjuvant intravesical Bacillus Calmette-Guerin (BCG) therapy with or without recombinant interferon alfa-2a allowed
- At least 4 weeks since other prior or concurrent radiotherapy, chemotherapy, or hormonal therapy
Exclusion
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00380029
Start Date
May 1 2006
End Date
June 1 2014
Last Update
July 19 2017
Active Locations (1)
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1
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7295