Status:
COMPLETED
Pilot Study of Preoperative Tarceva (Erlotinib) for Stages I/II Non-Small Cell Lung Cancer
Lead Sponsor:
Weill Medical College of Cornell University
Collaborating Sponsors:
OSI Pharmaceuticals
Conditions:
Carcinoma, Non-small Cell Lung
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
Brief 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 t...
Detailed Description
Tarceva® (erlotinib) is a drug that blocks a receptor called the Epidermal Growth Factor Receptor (EGFR) on certain cells including tumor cells. Blocking this receptor has been shown to shrink tumors ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00385996
Start Date
October 1 2006
End Date
August 1 2011
Last Update
December 28 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Weill Medical College of Cornell University
New York, New York, United States, 10021