Clinical trial NCT00137839: Erlotinib in Women With Previously Untreated Adenocarcinoma of the Lung
Official title: A Phase II Study of Erlotinib (OSI-774); Tarceva in Women With Previously Untreated Advance Adenocarcinoma of the Lung
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Adenocarcinoma
Non-small Cell Lung Cancer
Keywords: Tarceva
Erlotinib
OSI-774
Adenocarcinoma
Advanced Lung Cancer
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: Dana-Farber Cancer Institute
name: Massachusetts General Hospital
name: Brigham and Women's Hospital
name: Beth Israel Deaconess Medical Center
name: Genentech, Inc.
First posted: 2005-08-30
Enrollment: 84
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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 four (IV) or three (III) B 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

Primary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months.
Secondary outcomes:
measure: Overall Response Rate (ORR) by EGFR Mutation Status
timeFrame: In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months.
measure: Overall Survival (OS)
timeFrame: In this study cohort, participants were followed for survival up to 155 months.
measure: Overall Survival by EGFR Mutation Status
timeFrame: In this study cohort, participants were followed for survival up to 155 months.
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Pasi A Janne, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shepherd FA, Rodrigues Pereira J, Ciuleanu T, Tan EH, Hirsh V, Thongprasert S, Campos D, Maoleekoonpiroj S, Smylie M, Martins R, van Kooten M, Dediu M, Findlay B, Tu D, Johnston D, Bezjak A, Clark G, Santabarbara P, Seymour L; National Cancer Institute of Canada Clinical Trials Group. Erlotinib in previously treated non-small-cell lung cancer. N Engl J Med. 2005 Jul 14;353(2):123-32. doi: 10.1056/NEJMoa050753.
citation: Perez-Soler R, Chachoua A, Hammond LA, Rowinsky EK, Huberman M, Karp D, Rigas J, Clark GM, Santabarbara P, Bonomi P. Determinants of tumor response and survival with erlotinib in patients with non--small-cell lung cancer. J Clin Oncol. 2004 Aug 15;22(16):3238-47. doi: 10.1200/JCO.2004.11.057.
citation: Janne PA, Engelman JA, Johnson BE. Epidermal growth factor receptor mutations in non-small-cell lung cancer: implications for treatment and tumor biology. J Clin Oncol. 2005 May 10;23(14):3227-34. doi: 10.1200/JCO.2005.09.985.
citation: Paez JG, Janne PA, Lee JC, Tracy S, Greulich H, Gabriel S, Herman P, Kaye FJ, Lindeman N, Boggon TJ, Naoki K, Sasaki H, Fujii Y, Eck MJ, Sellers WR, Johnson BE, Meyerson M. EGFR mutations in lung cancer: correlation with clinical response to gefitinib therapy. Science. 2004 Jun 4;304(5676):1497-500. doi: 10.1126/science.1099314. Epub 2004 Apr 29.