Phase 2
Completed N=20
Erlotinib Before and After Surgery in Treating Patients With Muscle-Invasive Bladder Cancer
Source: ClinicalTrials.gov NCT00380029 ↗Enrolled (actual)
20
Serious AEs
34.8%
Results posted
Jun 2017
Primary outcomePrimary: EGFR Activation Signal (AKT2) Expression to Predict Sensitivity to Erlotinib — -0.29; 0.128 fold change
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY EGFR Activation Signal (AKT2) Expression to Predict Sensitivity to Erlotinib |
-0.29; 0.128 | — |
| SECONDARY Pathological Complete Response Rate |
5 | — |
| SECONDARY Disease Recurrence and Progression Rates After Cystectomy |
4 | — |
| SECONDARY Overall Survival Rate |
10 | — |
| SECONDARY Number of Subjects Experiencing Adverse Events |
15; 6; 6; 0; 6; 1 | — |
Eligibility 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:
- 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
Data sourced from ClinicalTrials.gov (NCT00380029). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.