Erlotinib Before and After Surgery in Treating Patients With Muscle-Invasive Bladder Cancer

NCT00380029 | Completed Phase 2 Results DMC

• 2 other identifiers: LCCC 0521P30CA016086
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Bladder Cancer

Keywords

stage II bladder cancer; transitional cell carcinoma of the bladder

Outcome Measures

Primary Outcomes (1)

• EGFR Activation Signal (AKT2) Expression to Predict Sensitivity to Erlotinib

  Determine the effect of neoadjuvant erlotinib hydrochloride on histopathological, molecular, and genetic correlates in patients undergoing radical cystectomy for muscle-invasive bladder cancer. Gene expression of pre-treatment and post-treatment tumor samples were analyzed to define molecular determinants of response or resistance to epidermal growth factor receptor (EGFR) inhibition. Both in vitro and in vivo EGFR-associated signatures were evaluated on pre-treatment bladder tumors. Candidate molecular determinants of sensitivity to EGFR inhibition were characterized and examined for their ability to predict sensitivity to EGFR inhibitors in vitro.

  4 weeks before treatment and 4 weeks post treatment

Secondary Outcomes (4)

• Pathological Complete Response Rate

  4 weeks

• Disease Recurrence and Progression Rates After Cystectomy

  2 years

• Overall Survival Rate

  25 months

• Number of Subjects Experiencing Adverse Events

  4 weeks - 2 years following surgery

Study Arms (1)

Erlotinib

EXPERIMENTAL

erlotinib given before and after transurethral resection of a bladder tumor, TURBT

Drug: Erlotinib; Procedure: Radical Cystectomy

Interventions

Erlotinib DRUG

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

Also known as: Tarceva

Erlotinib

Radical Cystectomy PROCEDURE

Will occur 4 weeks prior to dosing with erlotinib

Erlotinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• OSI Pharmaceuticals: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, 27599-7295, United States

Location

Related Publications (1)

• Pruthi RS, Nielsen M, Heathcote S, Wallen EM, Rathmell WK, Godley P, Whang Y, Fielding J, Schultz H, Grigson G, Smith A, Kim W. A phase II trial of neoadjuvant erlotinib in patients with muscle-invasive bladder cancer undergoing radical cystectomy: clinical and pathological results. BJU Int. 2010 Aug;106(3):349-54. doi: 10.1111/j.1464-410X.2009.09101.x. Epub 2010 Jan 19.

  PMID: 20089114 RESULT

Related Links

• UNC Lineberger Comprehensive Cancer Center

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Erlotinib Hydrochloride; Cystectomy

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Urologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Results Point of Contact

• Title: Robin V. Johnson
• Organization: UNC Lineberger Comprehensive Cancer Center

Robin_V_Johnson@med.unc.edu

919-966-1125

Study Officials

• Raj S. Pruthi, MD

  UNC Lineberger Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2006
• First Posted: September 25, 2006
• Study Start: May 1, 2006
• Primary Completion: August 1, 2010
• Study Completion: June 1, 2014
• Last Updated: July 19, 2017
• Results First Posted: June 19, 2017

Record last verified: 2017-06

Locations

US (1)