Clinical trial · Interventional
Erlotinib Before and After Surgery in Treating Patients With Muscle-Invasive Bladder Cancer
A Phase II Study of Erlotinib (Tarceva®) in Patients With Muscle-Invasive Bladder Cancer Undergoing Radical Cystectomy
NCT00380029CI-TRIAL-00028690completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Erlotinib | Drug | Erlotinib | ALIAS |
| Radical Cystectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Erlotinib
- description
- erlotinib given before and after transurethral resection of a bladder tumor, TURBT
- interventionNames
- Drug: Erlotinib
- Procedure: Radical Cystectomy
Primary outcomes (1)
- measure
- EGFR Activation Signal (AKT2) Expression to Predict Sensitivity to Erlotinib
- timeFrame
- 4 weeks before treatment and 4 weeks post treatment
- description
- 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.
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTPruthi 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