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The purpose of this noncomparative study is to obtain preliminary estimates of the efficacy of erlotinib and standard chemotherapy in patients with advanced, previously untreated nonsmall cell lung cancer (NSCLC) and an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 2. The study will also evaluate the safety of single-agent erlotinib in this patient population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Erlotinib | Experimental | Erlotinib tablets administered orally, 150 mg/day (starting dose) or 100 mg/day (reduced dose), continuous therapy |
|
| Standard Chemotherapy | Active Comparator | Paclitaxel 200 mg/m^2 IV infusion over 3 hours and carboplatin AUC 6 mg/mL x min IV over 15 - 30 minutes, both given on Day 1 every 21 days for 4 cycles |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tarceva (Trademark) (erlotinib HCl, OSI-774) | Drug | Erlotinib tablets administered orally, 150 mg/day (starting dose) or 100 mg/day (reduced dose), continuous therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival | Median time until disease progression. Disease progression defined as radiological and/or symptomatic disease progression or death in absence of progression. | Until time of disease progression (maximum 5 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Median number of months from first study treatment until time of death | From first study treatment until time of death (maximum 26.8 months) |
| Best Tumor Response | Change in size of tumor: Complete Response (CR) = no measurable tumor; Partial Response (PR) = 30% decrease in size of measurable tumor; Stable Disease (SD) = measurable tumor size has not changed; Progressive Disease (PD) = measurable tumor 20% larger than at baseline. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| California Cancer Care, Inc. | Greenbrae | California | 94904 | United States | ||
| Sharp Clinical Oncology Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18281658 | Result | Lilenbaum R, Axelrod R, Thomas S, Dowlati A, Seigel L, Albert D, Witt K, Botkin D. Randomized phase II trial of erlotinib or standard chemotherapy in patients with advanced non-small-cell lung cancer and a performance status of 2. J Clin Oncol. 2008 Feb 20;26(6):863-9. doi: 10.1200/JCO.2007.13.2720. |
| Label | URL |
|---|---|
| OSI Pharmaceuticals website | View source |
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The first patient was treated 17 March 2004 and the last patient completed 19 March 2007.
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| ID | Title | Description |
|---|---|---|
| FG000 | Erlotinib | Erlotinib 150 mg/day continuous therapy |
| FG001 | Standard Chemotherapy | Paclitaxel 200 mg/m^2 IV infusion over 3 hours and carboplatin AUC 6 mg/mL x min IV over 15 - 30 minutes, both given on Day 1 every 21 days for 4 cycles |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Combination carboplatin and paclitaxel | Drug | Paclitaxel 200 mg/m^2 IV infusion over 3 hours and carboplatin AUC 6 mg/mL x min IV over 15 - 30 minutes, both given on Day 1 every 21 days for 4 cycles |
|
| While receiving study treatment (maximum 60 weeks) |
| San Diego |
| California |
| 92123 |
| United States |
| Holy Cross Hospital | Fort Lauderdale | Florida | 33308 | United States |
| University of Miami | Miami | Florida | 33136 | United States |
| Mount Sinai Cancer Center | Miami Beach | Florida | 33140 | United States |
| Evanston Northwestern Healthcare | Evanston | Illinois | 60201 | United States |
| Oncology/Hematology Associates of Central Illinois | Peoria | Illinois | 61615 | United States |
| Norton Healthcare, Inc. | Louisville | Kentucky | 40202 | United States |
| Maryland Hematology/Oncology Associates | Baltimore | Maryland | 21237 | United States |
| VA Sierra Nevada Health Care System | Reno | Nevada | 89502 | United States |
| Weill Medical College of Cornell University | New York | New York | 10021 | United States |
| FEK Addo, PC | Bismarck | North Dakota | 58503 | United States |
| Gabrail Cancer Center | Canton | Ohio | 44718 | United States |
| University Hospitals of Cleveland | Cleveland | Ohio | 44106 | United States |
| Ohio State University | Columbus | Ohio | 43210-1240 | United States |
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | United States |
| Charleston Hematology Oncology | Charleston | South Carolina | 29403 | United States |
| East Tennessee Oncology/Hematology, PC | Knoxville | Tennessee | 37920 | United States |
| Sarah Cannon Cancer Center | Nashville | Tennessee | 37203 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Erlotinib | Erlotinib 150 mg/day continuous therapy |
| BG001 | Standard Chemotherapy | Paclitaxel 200 mg/m^2 IV infusion over 3 hours and carboplatin AUC 6 mg/mL x min IV over 15 - 30 minutes, both given on Day 1 every 21 days for 4 cycles |
| BG002 | Total | Total of all reporting groups |
| 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 | Number | 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 | Progression-free Survival | Median time until disease progression. Disease progression defined as radiological and/or symptomatic disease progression or death in absence of progression. | All patients who received at least 1 dose of study drug and who had both a baseline and at least one on-treatment tumor assessment. | Posted | Median | 95% Confidence Interval | months | Until time of disease progression (maximum 5 months) |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Overall Survival | Median number of months from first study treatment until time of death | All patients who received at least 1 dose of study drug and who had both a baseline and at least one on-treatment tumor assessment. | Posted | Median | 95% Confidence Interval | months | From first study treatment until time of death (maximum 26.8 months) |
|
| |||||||||||||||||||||||||||||
| Secondary | Best Tumor Response | Change in size of tumor: Complete Response (CR) = no measurable tumor; Partial Response (PR) = 30% decrease in size of measurable tumor; Stable Disease (SD) = measurable tumor size has not changed; Progressive Disease (PD) = measurable tumor 20% larger than at baseline. | All patients who received at least 1 dose of study drug and who had both a baseline and at least one on-treatment tumor assessment. | Posted | Number | participants | While receiving study treatment (maximum 60 weeks) |
|
|
While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
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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/day continuous therapy | 24 | 52 | 51 | 52 | ||
| EG001 | Standard Chemotherapy | Paclitaxel 200 mg/m^2 IV infusion over 3 hours and carboplatin AUC 6 mg/mL x min IV over 15 - 30 minutes, both given on Day 1 every 21 days for 4 cycles | 13 | 51 | 50 | 51 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Lung infiltration | Respiratory, thoracic and mediastinal disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (6.1) | Systematic Assessment |
| |
| Endocarditis | Infections and infestations | MedDRA (6.1) | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA (6.1) | Systematic Assessment |
| |
| Pneumonia haemophilus | Infections and infestations | MedDRA (6.1) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (6.1) | Systematic Assessment |
| |
| Staphylococcal bacteraemia | Infections and infestations | MedDRA (6.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (6.1) | Systematic Assessment |
| |
| Viral diarrhoea | Infections and infestations | MedDRA (6.1) | Systematic Assessment |
| |
| Streptococcal infection | Infections and infestations | MedDRA (6.1) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Cardiac fibrillation | Cardiac disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Cardiac tamponade | Cardiac disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Ventricular fibrillation | Cardiac disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Impaired gastric emptying | Gastrointestinal disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Gastric ulcer perforation | Gastrointestinal disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Malignant pleural effusion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (6.1) | Systematic Assessment |
| |
| Metastatic pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (6.1) | Systematic Assessment |
| |
| Pericardial effusion malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (6.1) | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Ischaemic limb pain | Vascular disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Vena cava thrombosis | Vascular disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Hypotention | Vascular disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Optic neuritis | Eye disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Death | General disorders | MedDRA (6.1) | Systematic Assessment |
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| Chest discomfort | General disorders | MedDRA (6.1) | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA (6.1) | Systematic Assessment |
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| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (6.1) | Systematic Assessment |
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| Mental status changes | Psychiatric disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA (6.1) | Systematic Assessment |
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| Anaemia | Blood and lymphatic system disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (6.1) | Systematic Assessment |
| |
| International normalised ratio increased | Investigations | MedDRA (6.1) | Systematic Assessment |
| |
| Brain oedema | Nervous system disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA (6.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Dysgeusia | Gastrointestinal disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (6.1) | Systematic Assessment |
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| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Dermatitis exfoliative | Skin and subcutaneous tissue disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA (6.1) | Systematic Assessment |
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| Fatigue | General disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (6.1) | Systematic Assessment |
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| Asthenia | General disorders | MedDRA (6.1) | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Chest wall pain | Musculoskeletal and connective tissue disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (6.1) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Keratoconjunctivitis sicca | Eye disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (6.1) | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA (6.1) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Monitor | Astellas Pharma Global Development | clinicaltrials@us.astellas.com |
| 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 |
| D010330 | Patents as Topic |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D018973 | Intellectual Property |
| D007603 | Jurisprudence |
| D012926 | Social Control, Formal |
| D004472 | Health Care Economics and Organizations |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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| Male |
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| Black |
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| Hispanic |
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| Asian |
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