Erlotinib Hydrochloride in Treating Patients With Bladder Cancer Undergoing Surgery

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02169284
• Date of registration: 19/06/2014
• Prospective Registration: Yes
• Primary sponsor: National Cancer Institute (NCI)
• Public title: Erlotinib Hydrochloride in Treating Patients With Bladder Cancer Undergoing Surgery
• Scientific title: Phase II Clinical Chemoprevention Trial of Weekly Erlotinib Before Bladder Cancer Surgery
• Date of first enrolment: October 1, 2014
• Target sample size: 50
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02169284
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Tracy Downs
• Affiliation: University of Wisconsin, Madison

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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

- Aspartate aminotransferase (AST) =< 1.5 x upper limit of normal

- Alanine aminotransferase (ALT) =< 1.5 x upper limit of normal

- Bilirubin for Gilbert's =< 3.0 mg/dl

- A calculated creatinine clearance (Cockcroft Gault) of >= 30 ml/min

- Sodium >= 130 mg/dl and =< upper limit of normal

- Potassium >= 3.0 mg/dl and =< upper limit of normal

- Women of child-bearing potential and men must agree to use adequate contraception
(hormonal or barrier method of birth control; abstinence) prior to study entry and for
the duration of study participation; should a woman become pregnant or suspect she is
pregnant while participating in this study, she should inform her study physician
immediately

- Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

- 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Bladder Carcinoma

Recurrent Bladder Carcinoma

Intervention(s)

Other: Laboratory Biomarker Analysis

Drug: Erlotinib Hydrochloride

Other: Placebo

Other: Pharmacological Study

Other: Quality-of-Life Assessment

Procedure: Therapeutic Conventional Surgery

Primary Outcome(s)

EGFR Phosphorylation in Normal Appearing Bladder Epithelium Adjacent to Tumor [Time Frame: Up to 18 hours after last study drug dose (on day 28)]

Secondary Outcome(s)

EGFR Phosphorylation in Neoplastic Bladder Epithelium 9-18 Hours Post-study Dose [Time Frame: Up to 18 hours after last study drug dose (on day 28)]

Pharmacokinetic Parameters: OSI-420 in Blood [Time Frame: Baseline, day 8, and day 16 (day of surgery)]

Difference Between Normal and Neoplastic Tissue Phosphorylated ERK [Time Frame: At time of surgery (approximately day 16)]

Frequency of Urination Symptoms in Men Only, Graded According to International Prostate Symptom Score (I-PSS) [Time Frame: Baseline up to 18 hours after last study drug dose (on day 28)]

Difference Between Normal and Neoplastic Tissue of Let-7 [Time Frame: At time of surgery (approximately day 16)]

Pharmacokinetic Parameters: Erlotinib in Blood [Time Frame: Baseline, day 8, and day 16 (day of surgery)]

Percentage of Cells Expressing Ki67 [Time Frame: At time of surgery (approximately day 16)]

Difference Between Normal and Neoplastic Tissue of p53 [Time Frame: At time of surgery (approximately day 16)]

Expression of E-cadherin [Time Frame: At time of surgery (approximately day 16)]

Secondary ID(s)

N01CN00033

CO12336

NCI-2014-01320

UWI2013-01-02

HHSN261201200033I

N01-CN-2012-00033

P30CA014520

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 07/07/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02169284