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| Name | Class |
|---|---|
| OSI Pharmaceuticals | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Erlotinib | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tarceva (Erlotinib) | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Response Rate Defined as the Percentage of Subjects Achieving at Least 50% Tumor Volume Reduction. | 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. | High resolution CT scans for response assessment will be obtained after 3 weeks of treatment with Tarceva®. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Grade 3, 4, or 5 Treatment Related Adverse Events as Assessed by CTCAE v3.0. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nasser K Altorki, MD | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weill Medical College of Cornell University | New York | New York | 10021 | United States |
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The recruitment period was from 10/13/06 to 10/8/08. Patients were recruited from the Weill Cornell Medical College Thoracic Surgery outpatient office.
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| ID | Title | Description |
|---|---|---|
| FG000 | Erlotinib | Erlotinib 150 mg po daily. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Erlotinib | Erlotinib 150 mg po daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Response Rate Defined as the Percentage of Subjects Achieving at Least 50% Tumor Volume Reduction. | 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. | Population per protocol | Posted | Count of Participants | Participants | High resolution CT scans for response assessment will be obtained after 3 weeks of treatment with Tarceva®. |
|
26 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Erlotinib | Erlotinib 150 mg po daily. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cerebral vascular accident | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nasser Altorki, MD | Weill Cornell Medical College | 212-746-5156 | nkaltork@med.cornell.edu |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D000069347 | Erlotinib Hydrochloride |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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|
| From Day 1 until 30 days after the last study drug dose, |
| Time-to-progression (TTP) | Defined as the time from surgical resection to the time of recurrent disease in the primary or in metastatic sites. | Every 3 months for the first 6 months, then yearly for 2 years. |
| Disease-free Survival (DFS) | Defined as the time from the start of treatment to the time of recurrent disease in the primary or in metastatic sites. | 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. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
|
| Secondary | Number of Participants With Grade 3, 4, or 5 Treatment Related Adverse Events as Assessed by CTCAE v3.0. | 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. | Per protocol | Posted | Count of Participants | Participants | From Day 1 until 30 days after the last study drug dose, |
|
|
|
| Secondary | Time-to-progression (TTP) | Defined as the time from surgical resection to the time of recurrent disease in the primary or in metastatic sites. | Posted | Median | Inter-Quartile Range | Months | Every 3 months for the first 6 months, then yearly for 2 years. |
|
|
|
|
| Secondary | Disease-free Survival (DFS) | Defined as the time from the start of treatment to the time of recurrent disease in the primary or in metastatic sites. | Posted | Median | Inter-Quartile Range | Months | 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. |
|
|
|
|
| 4 |
| 22 |
| 21 |
| 22 |
| Wound infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pulmonry embolus | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pruritis | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Anorexia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Epistaxis | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Mucositis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dry eyes | Eye disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Rhinitis | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dyspepsia/Heartburn | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Sore throat | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
|
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| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |