Erlotinib Hydrochloride in Treating Patients With Bladder Cancer Undergoing Surgery
Phase II Clinical Chemoprevention Trial of Weekly Erlotinib Before Bladder Cancer Surgery
7 other identifiers
interventional
50
1 country
6
Brief Summary
This randomized phase II trial studies how well erlotinib hydrochloride works in treating patients with bladder cancer undergoing surgery. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Oct 2014
Typical duration for phase_2
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 19, 2014
CompletedFirst Posted
Study publicly available on registry
June 23, 2014
CompletedStudy Start
First participant enrolled
October 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2018
CompletedResults Posted
Study results publicly available
July 7, 2020
CompletedJuly 7, 2020
June 1, 2020
3.5 years
June 19, 2014
January 31, 2020
June 24, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
EGFR Phosphorylation in Normal Appearing Bladder Epithelium Adjacent to Tumor
EGFR phosphorylation will be assessed using Immunohistochemistry (IHC), greater mean optical density is associated with greater phosphorylation. The difference between the placebo group and the erlotinib hydrochloride group will be tested as-randomized using a two-sample t-test with normalizing transformation if necessary or Wilcoxon rank-sum test.
Up to 18 hours after last study drug dose (on day 28)
Secondary Outcomes (9)
EGFR Phosphorylation in Neoplastic Bladder Epithelium 9-18 Hours Post-study Dose
Up to 18 hours after last study drug dose (on day 28)
Pharmacokinetic Parameters: Erlotinib in Blood
Baseline, day 8, and day 16 (day of surgery)
Pharmacokinetic Parameters: OSI-420 in Blood
Baseline, day 8, and day 16 (day of surgery)
Frequency of Urination Symptoms in Men Only, Graded According to International Prostate Symptom Score (I-PSS)
Baseline up to 18 hours after last study drug dose (on day 28)
Expression of E-cadherin
At time of surgery (approximately day 16)
- +4 more secondary outcomes
Study Arms (2)
Group I (erlotinib hydrochloride)
EXPERIMENTALPatients receive erlotinib hydrochloride PO QD on days 1, 8, and 15. Patients then undergo TURBT or cystectomy on day 16.
Group II (placebo)
PLACEBO COMPARATORPatients receive placebo PO QD on days 1, 8, and 15. Patients then undergo TURBT or cystectomy on day 16.
Interventions
Given PO
Correlative studies
Ancillary studies
Undergo TURBT or cystectomy
Eligibility Criteria
You may qualify if:
- Participants must have a confirmed or suspected invasive or non-invasive bladder tumor (initial or recurrent) discovered on cystoscopy or radiologic imaging performed within 120 days of randomization
- Patients with muscle invasive bladder cancer (MIBC) must have never received and currently be ineligible for cisplatin-based neoadjuvant chemotherapy due to any of the following:
- Calculated creatinine clearance of \< 60 ml/min
- Karnofsky performance status (KPS) \< 80
- Solitary kidney or
- Patient refusal to undergo neoadjuvant chemotherapy
- The participant may have prior treatment for bladder tumor (excluding radiation therapy) provided that treatment:
- Was completed greater than 30 days prior to the first dose of study agent
- Participants must be a candidate for a trans-urethral resection of the bladder tumor (TURBT), cystectomy (partial or radical) or cystoscopy with biopsy at a participating organization
- Karnofsky \>= 60%
- White blood cells (WBC) \>= 3000/mm\^3
- Platelets \>= 100,000mm\^3
- Hemoglobin \> 10 g/dL
- Alkaline phosphatase =\< 1.5 x upper limit of normal
- Bilirubin =\< 1.5 x upper limit of normal
- +8 more criteria
You may not qualify if:
- Any treatment for the bladder tumor other than intravesical therapy between the pre-study cystoscopy or radiologic imaging which identified the suspected bladder tumor and the scheduled surgical removal or cystoscopy-guided biopsy of that tumor
- Any chemotherapy and/or radiation therapy received =\< 3 months of study entry and any immunotherapy received =\< 6 months of study entry (with the exception of Bacillus Calmette-Guerin \[BCG\] treatment)
- Any prior external beam radiation to the pelvis
- A concurrent skin rash or skin condition requiring treatment with a prescription medication
- The following medications may not be taken within 24 hours of the first dose of study agent or at any time while a participant is taking study agent
- Coumadin
- Strong CYP3A4 inhibitors including ketoconazole, atazanavir, boceprevir, ceritinib, clarithromycin, cobicistat, darunavir, dasabuvir, idelalisib, indinavir, itraconazole, lopinavir, nefazodone, nelfinavir, ombitasvir, paritaprevir, posaconazole, ritonavir, saquinavir, telithromycin, troleandomycin, voriconazole, and grapefruit or grapefruit juice
- CYP3A4 inducers including rifampicin, rifabutin, rifapentine, phenytoin, carbamazepine, phenobarbital, primidone, enzalutamide, fosphenytoin, lumacaftor, mitotane, and St. John's wort
- Agents which decrease gastric acid are allowed but should be avoided if possible
- Participants may resume inhibitors or inducers of CYP3A4 \> 14 days after their last dose of study agent
- Participants requiring daily use of non-steroidal anti-inflammatory drugs (NSAIDs), with the exception of =\< 81 mg aspirin per day; during study participation, acetaminophen is preferred for treatment of pain; the use of NSAIDs, as needed for pain, is discouraged
- Participants may not be receiving any other investigational agents
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to erlotinib or clindamycin (topical agent for potential skin toxicity)
- An underlying predisposition to rectal or gastrointestinal bleeding or uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Females who are pregnant or lactating may not participate in this study; females of child-bearing potential must have a negative pregnancy test before starting study agent; patients who have had a bilateral oophorectomy, hysterectomy, or are greater than 1 year since their last menses are not considered to be of child-bearing potential
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, 21287, United States
Lahey Hospital and Medical Center
Burlington, Massachusetts, 01805, United States
University of Rochester
Rochester, New York, 14642, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572, United States
Urology San Antonio Research PA
San Antonio, Texas, 78229, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Tracy Downs
- Organization
- University of Wisconsin Carbone Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Tracy Downs
University of Wisconsin, Madison
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 19, 2014
First Posted
June 23, 2014
Study Start
October 1, 2014
Primary Completion
March 30, 2018
Study Completion
March 30, 2018
Last Updated
July 7, 2020
Results First Posted
July 7, 2020
Record last verified: 2020-06