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| Name | Class |
|---|---|
| Dana-Farber Cancer Institute | OTHER |
| Genentech, Inc. | INDUSTRY |
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In this research study erlotinib will be given to eligible participants whose lung cancer has been removed by surgery. Eligible patients have adenocarcinoma, a type of non-small lung cancer, and must have 1 or more of the following characteristics: be female, be of Asian or Pacific Rim descent and/or be a never smoker. The potential participant's tumor will be examined for Epidermal growth factor (EGFR) mutations. EGFR is a protein that is overexpressed in most non-small cell lung cancers. Some EGFR has been found to have specific mutations and the participant must have one of these mutations in his tumor.
Erlotinib blocks this protein and may control tumor growth and increase survival. Previous research has shown that erlotinib is most effective for people who have these specific mutations in the EGFR.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Erlotinib | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erlotinib | Drug | Oral drug taken daily around the same time. Starting dose is 150mg once daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 2-year Disease-free Survival | The number of participants alive and free from disease recurrence 2 years after enrollment. Participants were monitored for disease recurrence with the use of surveillance radiographs. When possible and medically appropriate, tissue biopsies were obtained to prove recurrence. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treat Related Serious Adverse Events | Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE 3.0) from the start of treatment until 30 days after the end of treatment. Serious adverse events were defined as adverse events that were grade 3 or greater and deemed to be possibly, probably or definitely related to the study treatment. | From the start of treatment until 30 days after the end of treatment, up 13 months total |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lecia V. Sequist, MD, MPH | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Stanford | California | 94305 | United States | ||
| Massachusetts General Hosptial |
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| ID | Title | Description |
|---|---|---|
| FG000 | Erlotinib | Erlotinib: Oral drug taken daily around the same time. Starting dose is 150mg once daily. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 1, 2009 |
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| Median Overall Survival | The median amount of time from the time of registration until death due to any cause | From the time of registration until death, up to approximately 9 years |
| Median Disease Free Survival | The median amount of time measured from the time of registration until the time of disease recurrence or death. | From registration to disease recurrence or death, up to approximately 9 years |
| Boston |
| Massachusetts |
| 02114 |
| United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02115 | United States |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02115 | United States |
| North Shore Medical Center | Peabody | Massachusetts | 01960 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10021 | United States |
| Taussig Cancer Center | Cleveland | Ohio | 44195 | United States |
| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Erlotinib | Erlotinib: Oral drug taken daily around the same time. Starting dose is 150mg once 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 | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||||
| Smoking Status | Count of Participants | Participants |
| ||||||||||||||||||
| Stage | Cancer stage is a measure of disease progression. The later stage indicates more advanced cancer. So, the Participants with Stage II cancer have more advanced disease than stage I participants. The letters represent sub groups within a given stage, with B representing more advanced cancer than A. | Count of Participants | Participants |
| |||||||||||||||||
| EGFR Mutation | Epidermal Growth Factor Receptor (EGFR) allows healthy cells to grow and divide. A mutation in the EGFR gene can lead to cells having too many receptors. This can cause the cells to continue to grow and divide more than normal tissue, as happens in cancer. | Count of Participants | Participants |
|
| 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 | 2-year Disease-free Survival | The number of participants alive and free from disease recurrence 2 years after enrollment. Participants were monitored for disease recurrence with the use of surveillance radiographs. When possible and medically appropriate, tissue biopsies were obtained to prove recurrence. | Posted | Count of Participants | Participants | 2 years |
|
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants With Treat Related Serious Adverse Events | Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE 3.0) from the start of treatment until 30 days after the end of treatment. Serious adverse events were defined as adverse events that were grade 3 or greater and deemed to be possibly, probably or definitely related to the study treatment. | Posted | Count of Participants | Participants | From the start of treatment until 30 days after the end of treatment, up 13 months total |
|
| ||||||||||||||||||||||||||||
| Secondary | Median Overall Survival | The median amount of time from the time of registration until death due to any cause | Posted | Median | 95% Confidence Interval | years | From the time of registration until death, up to approximately 9 years |
|
|
| ||||||||||||||||||||||||||
| Secondary | Median Disease Free Survival | The median amount of time measured from the time of registration until the time of disease recurrence or death. | Median Disease Free Survival had not been met by the time of data cutoff. | Posted | Median | 95% Confidence Interval | years | From registration to disease recurrence or death, up to approximately 9 years |
|
|
From the start of treatment until 30 days after the end of treatment, up to 13 months total
Further descriptions are not available for adverse events listed as 'Other' under an organ system.
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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: Oral drug taken daily around the same time. Starting dose is 150mg once daily. | 0 | 100 | 20 | 100 | 99 | 100 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea w/o prior colostomy | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hepatic-other | Hepatobiliary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Muco/stomatitis by exam- oral cavity | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pruritus/itching | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Rash/desquamation | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Rash: acne/acneiform | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Skin-other | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Tearing | Eye disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hemoglobin | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Leukocytes | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Nail changes | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pruritus/itching | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Rash/desquamation | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Rash: acne/acneiform | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Erythema multiforme | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Skin-other | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Diarrhea w/o prior colostomy | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Muco/stomatitis by exam, oral cavity | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Taste disturbance | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| GI-other | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Nose, hemorrhage | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| ALT, SGPT | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| AST, SGOT | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Bilirubin | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Musculoskeletal/soft tissue-other | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Neuropathy-sensory | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dry eye syndrome | Eye disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Ocular-other | Eye disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Abdomen, pain | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Back, pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Extremity-limb, pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Head/headache | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Joint, pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Muscle, pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain-other | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pulmonary/Upper Respiratory-other | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lecia Van Dam Sequist, M.D. | Massachusetts General Hospital | 617-724-4000 | LVSEQUIST@PARTNERS.ORG |
| Oct 19, 2018 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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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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| >10 pack years + current |
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| Stage IIA |
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| Stage IIB |
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| Stage IIIA |
|
| G719X |
|
| L861Q |
|
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| Denominators |
|---|
| Categories |
|---|
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
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