Pilot Study of Preoperative Tarceva (Erlotinib) for Stages I/II Non-Small Cell Lung Cancer

• Status: Completed
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The main purpose of this study is to see if Tarceva® (erlotinib) is effective in shrinking tumors. A high resolution CT scan (CT scanner that can view 3 dimensional images of the tumor) will be used to measure the tumor before and after treatment with Tarceva®(erlotinib) . This type of CT scan will measure the tumor by volume and by standard measurement (length and width). Both methods will be compared to find out whether standard measurement or measurement by tumor volume is more accurate.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Weill Medical College of Cornell University
• Collaborator: OSI Pharmaceuticals
• Treatments: Erlotinib Hydrochloride

Criteria

Inclusion Criteria:

• Biopsy proven stage I/II non-small cell lung cancer who are candidates for surgical resection

• Ambulatory and capable of all self-care but may be unable to carry out any work activities.

• Preoperative and postoperative high resolution CT scans done at NYPH-Weill Cornell medical center for purposes of volumetric measurements.

• Acceptable cardiac, breathing, kidney, liver, and bone marrow functions.

• 18 years and older.

• Women of child-bearing potential must be taking adequate contraceptive precautions prior to study entry and for the duration of study participation. A negative serum or urine pregnancy test is required within 7-10 days of Tarceva® administration. Men and premenopausal women of child bearing potential will follow an approved, medically accepted birth control regimen or agree to abstain from heterosexual intercourse while taking study drug and for 30 days following the last dose of study drug.

Exclusion Criteria:

• Cannot be on any other anti-cancer treatment during this study.

• Prior treatment with any EGFR inhibitor.

• Patients who had prior treatment with chemotherapy or radiation for this disease.

• Other active cancers.

• Tumors with a mixed histology of small cell and non-small cell carcinoma as well as patients with pulmonary carcinoid tumors.

• Gastro-intestinal abnormalities, including active peptic ulcer or inflammatory bowel disease.

• Hypersensitivity to compounds similar in chemical composition to Tarceva®.

• Active infection or serious underlying medical conditions which would impair protocol treatment.