Erlotinib in Women With Previously Untreated Adenocarcinoma of the Lung

Non-small Cell Lung Cancer Clinical Trial

Official title:

A Phase II Study of Erlotinib (OSI-774); Tarceva in Women With Previously Untreated Advance Adenocarcinoma of the Lung

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00137839
• Other study ID #: 04-253
• Status: Completed
• Phase: Phase 2
• Start date: November 2004
• Est. completion date: July 2019

Study information

• Verified date: December 2019
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: July 2019
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of Lung
• Non-small Cell Lung Cancer

Intervention

Drug:
• Erlotinib

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (6)

Lead Sponsor	Collaborator
Pasi A. Janne, MD, PhD	Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, Dana-Farber Cancer Institute, Genentech, Inc., Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

References & Publications (4)

Jänne 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. Review. — View Citation

Paez JG, Jänne 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. Epub 2004 Apr 29. — View Citation

Pérez-Soler R, Chachoua A, Hammond LA, Rowinsky EK, Huberman M, Karp D, Rigas J, Clark GM, Santabárbara 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. — View 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, Santabárbara 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Response Rate (ORR)	ORR is defined as the percentage of participants who achieve partial response (PR) or better on treatment based on RECIST 1.0 criteria: For target lesions, complete response (CR) is disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD (both require a minimum of 4 weeks). Progressive disease (PD) is at least a 20% increase in sum LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started, or appearance of one or more new target lesions. Stable disease (SD) is neither PR nor PD. For non-target lesions, PD is the appearance of one or more new non-target lesions and/or unequivocal progression of existing non-target lesions.	In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months.
Secondary	Overall Response Rate (ORR) by EGFR Mutation Status	ORR is defined as the percentage of participants who achieve partial response (PR) or better on treatment based on RECIST 1.0 criteria: For target lesions, complete response (CR) is disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD (both require a minimum of 4 weeks). Progressive disease (PD) is at least a 20% increase in sum LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started, or appearance of one or more new target lesions. SD is neither PR nor PD. For non-target lesions, PD is the appearance of one or more new non-target lesions and/or unequivocal progression of existing non-target lesions.	In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months.
Secondary	Overall Survival (OS)	OS is defined as the time from study entry to death or date last known alive.	In this study cohort, participants were followed for survival up to 155 months.
Secondary	Overall Survival by EGFR Mutation Status	OS is defined as the time from study entry to death or date last known alive.	In this study cohort, participants were followed for survival up to 155 months.

External Links

•   Dana-Farber Cancer Institute Lowe Thoracic Oncology Program