This trial is active, not recruiting.

Condition bladder cancer
Treatments erlotinib, radical cystectomy
Phase phase 2
Target EGFR
Sponsor UNC Lineberger Comprehensive Cancer Center
Collaborator National Cancer Institute (NCI)
Start date May 2006
End date August 2010
Trial size 27 participants
Trial identifier NCT00380029, LCCC 0521, P30CA016086, UNC-LCCC-0521


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 normal tissue that needs to be removed. Giving erlotinib after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This phase II trial is studying how well erlotinib works when given before and after surgery in treating patients with muscle-invasive bladder cancer.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
erlotinib given before and after transurethral resection of a bladder tumor, TURBT
erlotinib Tarceva
Erlotinib will be given at a dose of 150 mg per day for 4 weeks before undergoing planned radical cystectomy. In addition, patients will continue on erlotinib daily at a dose of 150 mg per day (qd dosing) for up to 2 years after surgery (beginning within 12 weeks of surgery) or until evidence of disease recurrence or progression
radical cystectomy
Will occur 4 weeks prior to dosing with erlotinib

Primary Outcomes

Pathological Complete Response Rate
time frame: 4weeks

Secondary Outcomes

Disease Recurrence and Progression rates after cystectomy
time frame: 4 weeks after surgery
Overall Survival Rate
time frame: 5 years
Number of subjects experiencing adverse events
time frame: 4 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

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: - ECOG performance status 0-2 - Granulocyte count > 1,500/mm³ - Platelet count > 100,000/mm³ - Bilirubin normal - AST and 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

Additional Information

Official title A Phase II Study of Erlotinib (Tarceva®) in Patients With Muscle-Invasive Bladder Cancer Undergoing Radical Cystectomy
Principal investigator Raj S. Pruthi, MD
Description OBJECTIVES: Primary - Determine the effect of neoadjuvant erlotinib hydrochloride on histopathological, molecular, and genetic correlates in patients undergoing radical cystectomy for muscle-invasive bladder cancer. Secondary - Determine the pathological complete response rate in surgical specimens from patients treated with this drug. - Determine recurrence and progression rates after cystectomy (up to 2 years after surgery) in patients treated with neoadjuvant and adjuvant erlotinib hydrochloride. - Determine 2- and 5-year disease-free, disease-specific, and overall survival rates in patients treated with this drug. - Determine the safety of this drug in these patients. OUTLINE: This is an open-label study. Patients receive oral erlotinib hydrochloride once daily for 4 weeks. Patients then undergo radical cystectomy with curative intent. Within 12 weeks after surgery, patients resume oral erlotinib hydrochloride* once daily for up to 2 years in the absence of disease progression or unacceptable toxicity. NOTE: *Patients who are candidates for adjuvant chemotherapy (e.g., found to have pT3, N+ disease) do not receive erlotinib hydrochloride after surgery. Tumor tissue is obtained at baseline (at the original or confirmatory transurethral resection of the bladder tumor) and at the time of cystectomy for analysis of drug-specific and tissue-based biomarkers by western blot, immunohistochemistry, and gene array techniques. Histopathological, molecular, and genetic correlates are analyzed to better understand the potential effects of EGFR inhibition in transitional cell carcinoma and to determine the effect of neoadjuvant erlotinib on gene expression. Tumor tissue is also evaluated by real-time polymerase chain reaction to confirm drug effects on expected targets and on EGFR expression, activity, and affected signaling pathways in the disease state and by microarray analysis to define expression phenotypes correlating with outcome, distinguish responders from nonresponders, and determine effects of drug treatment on gene expression in disease. Patients are followed periodically for up to 5 years after surgery.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by UNC Lineberger Comprehensive Cancer Center.