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A Phase II Study of Erlotinib (Tarceva®) in Patients With Muscle-Invasive Bladder Cancer Undergoing Radical Cystectomy


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Bladder Cancer

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Trial Information

A Phase II Study of Erlotinib (Tarceva®) in Patients With Muscle-Invasive Bladder Cancer Undergoing Radical Cystectomy


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Pathological Complete Response Rate

Outcome Description:

Determine the pathological complete response rate (P0 rate)on histopathological, molecular, and genetic correlates before and after therapy to better understand the potential effects of EGFR inhibition in transitional cell carcinoma

Outcome Time Frame:

4weeks

Safety Issue:

No

Principal Investigator

Raj S. Pruthi, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UNC Lineberger Comprehensive Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

LCCC 0521

NCT ID:

NCT00380029

Start Date:

May 2006

Completion Date:

August 2015

Related Keywords:

  • Bladder Cancer
  • stage II bladder cancer
  • transitional cell carcinoma of the bladder
  • Urinary Bladder Neoplasms

Name

Location

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel Hill, North Carolina  27599-7570