Pilot Study of Preoperative Tarceva (Erlotinib) for Stages I/II Non-Small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT00385996|
Recruitment Status : Completed
First Posted : October 11, 2006
Results First Posted : November 14, 2012
Last Update Posted : December 28, 2018
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma, Non-small Cell Lung||Drug: Tarceva (Erlotinib)||Phase 2|
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 in some patients. Tarceva®(erlotinib) is approved for commercial use by the U.S. Food and Drug Administration for treatment of Non-Small Cell Lung Cancer (NSCLC) after failure of at least one chemotherapy treatment. However, it is not approved for the first treatment of Non-Small Cell Lung Cancer (NSCLC), which is the treatment used in this study.
Patients with early stage non-small cell lung cancer will receive daily Tarceva® (erlotinib) at 150 mg/day for 3 weeks followed by surgical resection at week 4. High resolution CT scans for tumor response assessment will be obtained at baseline and after 3 weeks of treatment with Tarceva® (erlotinib). Post-operative 2-year treatment with Tarceva® (erlotinib) will be offered to patients who had at least a 50% (half) decrease in size of their tumor after treatment with Tarceva® (erlotinib)and/or patients with tumors that were found to have the receptor, Epidermal Growth Factor Receptor (EGFR), on their tumor cells at the time of their surgery.
Post-operative chemotherapy will be administered at the discretion of the treating physician to patients with stages IB and II. Patients who receive post-operative chemotherapy will begin Tarceva (erlotinib)no sooner than 3 weeks from Day 1 of the last chemotherapy cycle and no longer than 6 months after surgery. Follow-up for recurrence and survival will continue for 2 years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of Preoperative Tarceva (Erlotinib) Monotherapy in Patients With Early Stage (I/II) Non-Small Cell Lung Cancer|
|Study Start Date :||October 2006|
|Actual Primary Completion Date :||November 2008|
|Actual Study Completion Date :||August 2011|
Erlotinib 150mg/day for 3 weeks followed by surgical resection at week 4 then daily Tarceva® at 150 mg/day for 2 years for those patients who had a response rate of at least 50% tumor volume reduction and/or have EGFR-positive tumor tissue determined by IHC and/or FISH.
Drug: Tarceva (Erlotinib)
Patients will receive daily erlotinib at 150 mg/day for 3 weeks followed by surgical resection at week 4 then daily Tarceva® at 150 mg/day for 2 years for those patients who had a response rate of at least 50% tumor volume reduction and/or have EGFR-positive tumor tissue determined by IHC and/or FISH.
- Response Rate Defined as the Percentage of Subjects Achieving at Least 50% Tumor Volume Reduction. [ Time Frame: High resolution CT scans for response assessment will be obtained after 3 weeks of treatment with Tarceva®. ]High resolution CT scans for response assessment were obtained at baseline and within 1 week after completion of erlotinib treatment. Volumetric and maximum diameter (RECIST) response criteria was determined by a radiologist blinded to the sequence of treatment. Response rate (RR) is defined as the percentage of subjects achieving at least 50% tumor volume reduction.
- Number of Participants With Grade 3, 4, or 5 Treatment Related Adverse Events as Assessed by CTCAE v3.0. [ Time Frame: From Day 1 until 30 days after the last study drug dose, ]
Safety will be measured by describing the incidence of AEs, including SAEs and discontinuation of study drug due to AEs, and incidence of abnormal clinical laboratory values from day 1 of treatment.
Grade 3 - Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL.
Grade 4 - Life-threatening consequences; urgent intervention indicated. Grade 5 - Death related to AE.
- Time-to-progression (TTP) [ Time Frame: Every 3 months for the first 6 months, then yearly for 2 years. ]Defined as the time from surgical resection to the time of recurrent disease in the primary or in metastatic sites.
- Disease-free Survival (DFS) [ Time Frame: From date of erlotinib start date until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 25 months. ]Defined as the time from the start of treatment to the time of recurrent disease in the primary or in metastatic sites.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00385996
|United States, New York|
|Weill Medical College of Cornell University|
|New York, New York, United States, 10021|
|Principal Investigator:||Nasser K Altorki, MD||Weill Medical College of Cornell University|