Overview

This trial is active, not recruiting.

Conditions adenocarcinoma, non-small cell lung cancer
Treatment erlotinib
Phase phase 2
Target EGFR
Sponsor Dana-Farber Cancer Institute
Collaborator Massachusetts General Hospital
Start date October 2004
End date April 2014
Trial size 75 participants
Trial identifier NCT00137839, 04-253

Summary

The purpose of this trial is to figure out what effects (good or bad) the investigational drug agent called Tarceva (erlotinib; OSI-774) has on women with previously untreated adenocarcinoma.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Measure
To determine how well non-small cell lung cancer cells in the body respond to Tarceva
time frame: 4 years

Secondary Outcomes

Measure
To determine the safety of Tarceva and what effects it has on women with adenocarcinoma of the lung
time frame: 4 years

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: - Female - Diagnosis of adenocarcinoma of the lung - Patient has had at least one core biopsy of her tumor - Must be willing to undergo epidermal growth factor receptor (EGFR) mutation testing of her tumor - Stage IV or IIIB non-small cell lung cancer - Non-smoker or former smoker. Non-smoker is defined as a person who smoked 100 or less cigarettes in her lifetime while a former smoker is defined as a person who has quit smoking one or more years ago. - Three or more weeks since last radiation therapy - Three or more weeks since last major surgery - Must at least be able to walk and capable of taking care of herself although unable to carry out work activities - Life expectancy of 8 weeks or more - Blood tests that show kidneys, liver and bone marrow to be working adequately - Women of child-bearing potential must agree to use adequate contraception prior to study entry and for the entire time enrolled in study Exclusion Criteria: - Prior exposure to Tarceva (OSI-774, erlotinib) - Uncontrolled central nervous system problems - Prior chemotherapy regimen - Difficulty swallowing - A disease or disorder that interferes with ability to digest and absorb food - Incomplete healing of previous oncologic or other major surgery - Significant medical history or unstable medical condition such as heart failure, active infection, uncontrolled high blood pressure - Pregnant or breast feeding - A medical condition that could make it unsafe for patient to participate in this study

Additional Information

Official title A Phase II Study of Erlotinib (OSI-774); Tarceva in Women With Previously Untreated Advance Adenocarcinoma of the Lung
Principal investigator Pasi A Janne, MD, PhD
Description Patients will start taking Tarceva daily by mouth on Day 1 and will continue taking this medication daily at home, until participation in the study ends. Every 28 days (one cycle) while the patient is taking Tarceva, they will be examined in the outpatient clinic (blood test and physical examination) and the doctor will determine if they should continue taking Tarceva. After every two cycles of treatment (every 8 weeks) standard radiological testing (CT scans, MRIs, and/or x-rays) of the cancer site(s) will be done to assess the response to the Tarceva treatment. While the patient is on this study and at the end of the study, the patient will undergo blood and urine tests, medical history evaluation, physical exams including measures of vital signs (blood pressure, heart rate, temperature, and respiration), bone scans, tumor biopsy sample, and various radiological tests to monitor the cancer and the patients health. The length of time on the study depends upon how the cancer responds to Tarceva and whether or not the patient experiences unacceptable side effects.
Trial information was received from ClinicalTrials.gov and was last updated in August 2013.
Information provided to ClinicalTrials.gov by Dana-Farber Cancer Institute.