Clinical trial NCT00971191: A Study In Patients Who Will Undergo Surgical Removal Of Non-Small Cell Lung Cancer To Evaluate Molecular Changes That Occur In Tumor Tissue After Short Term Exposure To PF-00299804
Official title: A Presurgical Study To Evaluate Molecular Changes That Occur In Human Non-Small Cell Lung Cancer Tissue After Short Term Exposure To PF-00299804
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Non-Small Cell Lung Cancer (NSCLC)
Keywords: Stage I - III surgical resection molecular change brief pre-operative exposure
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-09-03
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study will enroll patients who are planned to undergo surgical removal of their tumor. The goal of the study is to evaluate the changes that occur in the tumor after brief (about 8 days) exposure to the study drug.

Detailed description: The A7471031 study was terminated on May 2, 2012. The decision for unplanned study termination was triggered by feasibility of further conduct of this trial as only 22 of the protocol-specified 75 patients were enrolled since the study initiated in February 2010. Based on this low accrual rate it was determined that the study was highly unlikely to complete accrual and provide meaningful data. The discontinuation of the study is not due to any safety issue.

Eligibility criteria: Inclusion Criteria:

* Radiographs consistent with lung cancer for which resection is indicated upon histologic confirmation of non-small cell lung cancer.
* Patient willing to take PF-00299804 for 5 to 11 days and provide blood and tissue specimens as required in the study.

Exclusion Criteria:

* Prior or concurrent systemic anticancer therapy for cancer (immunotherapy, hormonotherapy, biological therapy, or chemotherapy) less than one year from time of consent.
* Prior or concurrent radiation therapy to tumor at site of planned resection.
* Congestive heart failure (LVEF \< 50%), uncontrolled hypertension, significant ventricular arrythmia.
* Drugs that are highly dependent on CYP2D6 for metabolism, or are generally accepted to have a risk of causing Torsades de Pointes.
* Prior or concurrent radiation therapy to tumor at site of planned resection.

Primary outcomes:
measure: To identify the molecular changes which occur in human non-small cell lung cancer tissue after short-term exposure to PF-00299804 administered at 45 mg daily after a loading dose
timeFrame: 30 months
Secondary outcomes:
measure: To correlate molecular changes with specific gene and protein changes (eg, mutations, amplifications, over expression) in members of the EGFR and HER2 signal transduction pathways (eg, KRAS, EGFR, HER2)
timeFrame: 30 months
measure: To assess the effect of short term treatment of PF-00299804 on serum levels of the extracellular domain of EGFR and other serum markers of HER signaling (eg, serum HER2/neu and serum E-cadherin)
timeFrame: 30 months
measure: To assess the relationship between the pharmacokinetic parameters with molecular changes detected in non-small cell lung cancer
timeFrame: 30 months
measure: To assess the safety and tolerability of PF-00299804 in this setting
timeFrame: 30 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Los Angeles
country: United States
facility: Pfizer Investigational Site
state: California
city: Los Angeles
country: United States
facility: Pfizer Investigational Site
state: California
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: