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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA068485 | U.S. NIH Grant/Contract | View source | |
| VU-VICC-THO-0640 | |||
| VU-VICC-070494 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Studying samples of tumor tissue, blood, and urine in the laboratory from patients receiving erlotinib may help doctors predict how patients will respond to treatment.
PURPOSE: The phase II trial is studying proteomic profiling to see how well it predicts response in patients receiving erlotinib for stage IIIB, stage IV, or recurrent non-small cell lung cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive oral erlotinib hydrochloride once daily until disease progression.
At the time of disease progression, patients receive standard chemotherapy comprising paclitaxel IV over 3 hours and carboplatin IV over 15-30 minutes on day 1. Patients with non-squamous cell non-small cell lung cancer also receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for up to 6 courses.
Tumor tissue, plasma, serum, and urine samples are collected at baseline for proteomics analysis.
After the completion of study treatment, patients are followed every 8 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Erlotinib followed by paclitaxel + carboplatin (+ bevacizumab in non-squamous) at the time disease progression. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bevacizumab | Drug | 15 mg/m2 given through a vein for every 3 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pre-treatment Tumor Proteomic Profile as a Predictor of Response, Stable Disease, or Progressive Disease | End of treatment date |
| Measure | Description | Time Frame |
|---|---|---|
| Pre-treatment Serum Proteomic Expression Pattern as a Predictor of Response to Erlotinib Hydrochloride and/or Carboplatin and Paclitaxel After Failing Treatment With Erlotinib Hydrochloride | End of treatment date | |
| Tumor Proteomic Profiles as Predictors of Response to Carboplatin and Paclitaxel After Failing Treatment With Erlotinib Hydrochloride |
Not provided
DISEASE CHARACTERISTICS:
Histologically confirmed non-small cell lung cancer (NSCLC), meeting 1 of the following criteria:
Measurable or evaluable disease is desirable but not required
No untreated symptomatic brain metastases
PATIENT CHARACTERISTICS:
ECOG performance status 0-2
ANC ≥ 1,500/mm³
Hemoglobin ≥ 9 g/dL
Platelet count ≥ 100,000/mm³
Creatinine ≤ 2.0 mg/dL
Total bilirubin ≤ 1.5 mg/dL
Normal hemostasis by history
PT/PTT within 0.5 seconds of normal range
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
Willing to undergo biopsy procedures
No known severe hypersensitivity to erlotinib hydrochloride or any of the excipients of this product
No other concurrent malignancies or malignancies diagnosed within the past 5 years, except basal cell carcinoma or cervical cancer in situ
No significant cardiac disease, including any of the following:
No evidence of clinically active interstitial lung disease
No evidence of any other severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)
No evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the trial
No uncontrolled hypertension
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| David Carbone, M.D., Ph.D. | Vanderbilt-Ingram Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida Shands Cancer Center | Gainesville | Florida | 32610-0232 | United States | ||
| Emory University |
10 participants were consented to participate in this trial, but were determined to be ineligible; 3 participants withdrew from the study prior to beginning treatment; 1 participant progressed before beginning treatment.
The recruitment period for this trial was October 2007 to July 2011. Participants were recruited at Vanderbilt Medical Center, Emory University, M.D. Anderson Cancer Center, University of Florida - Gainesville.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment | Erlotinib followed by paclitaxel + carboplatin (+ bevacizumab in non-squamous) at the time disease progression. bevacizumab: 15 mg/m2 given through a vein for every 3 weeks carboplatin: AUC = 6 given through a vein on day 1 of each cycle. erlotinib hydrochloride: 150 mg taken by mouth daily paclitaxel: 200 mg/m2 given through a vein on day 1 of each cycle. gene expression analysis: Blood and tissue collection. protein expression analysis: Blood and tissue collection. proteomic profiling: Blood and tissue collection. laboratory biomarker analysis: Blood and tissue collection. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| carboplatin |
| Drug |
AUC = 6 given through a vein on day 1 of each cycle. |
|
| erlotinib hydrochloride | Drug | 150 mg taken by mouth daily |
|
| paclitaxel | Drug | 200 mg/m2 given through a vein on day 1 of each cycle. |
|
| gene expression analysis | Genetic | Blood and tissue collection. |
|
| protein expression analysis | Genetic | Blood and tissue collection. |
|
| proteomic profiling | Genetic | Blood and tissue collection. |
|
| laboratory biomarker analysis | Other | Blood and tissue collection. |
|
| End of treatment date |
| Analysis of Individual and Pattern(s) of Erlotinib Hydrochloride-induced Genomic and Proteomic Biomarker Changes in Relation to Response or Non-response to Treatment | End of treatment date | End of treatment date |
| Correlation of the Efficacy and Toxicity of Erlotinib Hydrochloride With Expression of EGFR, EGFR Pathway, ErbB Family, and Other Related Biomarkers | End of treatment date |
| Determination of a Set of Biomarkers to be Evaluated in Tumor Tissue or Surrogate Tissues Prior to Treatment With Erlotinib Hydrochloride to Enable Patient Selection for Therapy | End of treatment date |
| Response Rate for Erlotinib Initial Therapy in Chemotherapy-naïve Patients With Advanced NSCLC | Number of patients in each response category, per RECIST v1.1, summarized as follows for target lesion criteria (see RECIST v1.1 for additional details): complete response (CR),disappearance of target lesions; partial response (PR), >=30% decrease in sum of longest diameter of target lesions; progressive disease (PD), >=20% increase in sum of LD of target lesions or appearance of new lesions; stable disease (SD), insufficient change in target lesions or new lesions to qualify as either PD or SD. The response rate is calculated as the percentage of PR+CR among patients assessed for response. | Through study completion, an average of 1 year |
| Progression-free Survival (PFS) for Erlotinib Initial Therapy in Chemotherapy-naïve Patients With Advanced NSCLC | PFS is defined as the time from on erlotinib treatment date to progression or death (whichever comes first) before cross-over to PC or PC+B. For those did not progressed nor died, they were censored at the last follow up (either the off erlotinib treatment date or lost follow up date). The median survival time and 95% confidence interval were estimated using Kaplan-meier method. | Through study completion, an average of 1 year |
| Number of Patients With Worst-grade Toxicities Per Grade | The intensity of the AE will be graded according to the Common Toxicity Criteria (CTC) of the (US) National Cancer Institute (NCI) - Cancer Therapy Evaluation Program (CTEP) [version 3.0 of December 2003] (Appendix B). Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE | Through study completion, an average of 1 year |
| Overall Survival for Erlotinib Initial Therapy in Chemotherapy-naïve Patients With Advanced NSCLC | The overall survival time is defined as the time from on treatment to death. Patients were censored of they were alive at the last follow up date. The median survival time and its confidence interval were estimated using Kaplan-meier method. | Through study completion, an average of 1 year |
| Atlanta |
| Georgia |
| 30308 |
| United States |
| University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan | 48109-0942 | United States |
| Vanderbilt-Ingram Cancer Center - Cool Springs | Nashville | Tennessee | 37064 | United States |
| Vanderbilt-Ingram Cancer Center at Franklin | Nashville | Tennessee | 37064 | United States |
| Vanderbilt-Ingram Cancer Center | Nashville | Tennessee | 37232-6838 | United States |
| M. D. Anderson Cancer Center at University of Texas | Houston | Texas | 77030-4009 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Treatment | Erlotinib followed by paclitaxel + carboplatin (+ bevacizumab in non-squamous) at the time disease progression. bevacizumab: 15 mg/m2 given through a vein for every 3 weeks carboplatin: AUC = 6 given through a vein on day 1 of each cycle. erlotinib hydrochloride: 150 mg taken by mouth daily paclitaxel: 200 mg/m2 given through a vein on day 1 of each cycle. gene expression analysis: Blood and tissue collection. protein expression analysis: Blood and tissue collection. proteomic profiling: Blood and tissue collection. laboratory biomarker analysis: Blood and tissue collection. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||||
| Region of Enrollment | 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 | Pre-treatment Tumor Proteomic Profile as a Predictor of Response, Stable Disease, or Progressive Disease | Lab data was lost by the collaborating institution, Colorado. | Posted | End of treatment date |
|
| ||||||||||||||||||||
| Secondary | Pre-treatment Serum Proteomic Expression Pattern as a Predictor of Response to Erlotinib Hydrochloride and/or Carboplatin and Paclitaxel After Failing Treatment With Erlotinib Hydrochloride | Lab data was lost by the collaborating institution, Colorado. | Posted | End of treatment date |
|
| ||||||||||||||||||||
| Secondary | Tumor Proteomic Profiles as Predictors of Response to Carboplatin and Paclitaxel After Failing Treatment With Erlotinib Hydrochloride | Lab data was lost by the collaborating institution, Colorado. | Posted | End of treatment date |
|
| ||||||||||||||||||||
| Secondary | Analysis of Individual and Pattern(s) of Erlotinib Hydrochloride-induced Genomic and Proteomic Biomarker Changes in Relation to Response or Non-response to Treatment | End of treatment date | Lab data was lost by the collaborating institution, Colorado. | Posted | End of treatment date |
|
| |||||||||||||||||||
| Secondary | Correlation of the Efficacy and Toxicity of Erlotinib Hydrochloride With Expression of EGFR, EGFR Pathway, ErbB Family, and Other Related Biomarkers | Lab data was lost by the collaborating institution, Colorado. | Posted | End of treatment date |
|
| ||||||||||||||||||||
| Secondary | Determination of a Set of Biomarkers to be Evaluated in Tumor Tissue or Surrogate Tissues Prior to Treatment With Erlotinib Hydrochloride to Enable Patient Selection for Therapy | Lab data was lost by the collaborating institution, Colorado. | Posted | End of treatment date |
|
| ||||||||||||||||||||
| Secondary | Response Rate for Erlotinib Initial Therapy in Chemotherapy-naïve Patients With Advanced NSCLC | Number of patients in each response category, per RECIST v1.1, summarized as follows for target lesion criteria (see RECIST v1.1 for additional details): complete response (CR),disappearance of target lesions; partial response (PR), >=30% decrease in sum of longest diameter of target lesions; progressive disease (PD), >=20% increase in sum of LD of target lesions or appearance of new lesions; stable disease (SD), insufficient change in target lesions or new lesions to qualify as either PD or SD. The response rate is calculated as the percentage of PR+CR among patients assessed for response. | Total 116 participants, 11 not assessed and 4 not evaluable. 101 assessed for response. | Posted | Mean | 95% Confidence Interval | percentage of patients assessed | Through study completion, an average of 1 year |
| |||||||||||||||||
| Secondary | Progression-free Survival (PFS) for Erlotinib Initial Therapy in Chemotherapy-naïve Patients With Advanced NSCLC | PFS is defined as the time from on erlotinib treatment date to progression or death (whichever comes first) before cross-over to PC or PC+B. For those did not progressed nor died, they were censored at the last follow up (either the off erlotinib treatment date or lost follow up date). The median survival time and 95% confidence interval were estimated using Kaplan-meier method. | Total 116 participants. One patient was excluded due to death before erlotinib treatment. Total 115 patients were included in the analysis. | Posted | Median | 95% Confidence Interval | months | Through study completion, an average of 1 year |
|
| ||||||||||||||||
| Secondary | Number of Patients With Worst-grade Toxicities Per Grade | The intensity of the AE will be graded according to the Common Toxicity Criteria (CTC) of the (US) National Cancer Institute (NCI) - Cancer Therapy Evaluation Program (CTEP) [version 3.0 of December 2003] (Appendix B). Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE | 116 paticipants, one patient was excluded due to death before any treatment. All patients who received erlotinib treatment and experienced an Adverse events. | Posted | Number | participants | Through study completion, an average of 1 year |
|
| |||||||||||||||||
| Secondary | Overall Survival for Erlotinib Initial Therapy in Chemotherapy-naïve Patients With Advanced NSCLC | The overall survival time is defined as the time from on treatment to death. Patients were censored of they were alive at the last follow up date. The median survival time and its confidence interval were estimated using Kaplan-meier method. | Total 116 participants. One patient was excluded due to death before any treatment. | Posted | Median | 95% Confidence Interval | months | Through study completion, an average of 1 year |
|
Patients were evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva. After discontinuation from treatment, patients are followed up for all existing and new AEs for 30 calendar days after the last dose of study drug. All new AEs occurring during that period are recorded and followed to resolution when possible.
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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 | Treatment | Erlotinib followed by paclitaxel + carboplatin (+ bevacizumab in non-squamous) at the time disease progression. bevacizumab: 15 mg/m2 given through a vein for every 3 weeks carboplatin: AUC = 6 given through a vein on day 1 of each cycle. erlotinib hydrochloride: 150 mg taken by mouth daily paclitaxel: 200 mg/m2 given through a vein on day 1 of each cycle. gene expression analysis: Blood and tissue collection. protein expression analysis: Blood and tissue collection. proteomic profiling: Blood and tissue collection. laboratory biomarker analysis: Blood and tissue collection. | 8 | 116 | 108 | 116 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection (urinary tract) | Infections and infestations | NCI-CTCAE version 3. | Systematic Assessment |
| |
| Pleural effusion (non-malignant) | Respiratory, thoracic and mediastinal disorders | NCI-CTCAE version 3. |
| ||
| Infection (pharynx) | Infections and infestations | NCI-CTCAE version 3. |
| ||
| Rash (allergy) | Skin and subcutaneous tissue disorders | NCI-CTCAE version 3. |
| ||
| Infection (port) | Infections and infestations | NCI-CTCAE version 3. | Systematic Assessment |
| |
| Pulmonary (other) | Respiratory, thoracic and mediastinal disorders | NCI-CTCAE version 3. |
| ||
| iatrogenic pneumothorax | Respiratory, thoracic and mediastinal disorders | NCI-CTCAE version 3. |
| ||
| worsening pneumothorax and subcutaneous emphysema. | Respiratory, thoracic and mediastinal disorders | NCI-CTCAE version 3. |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | NCI-CTCAE version 3. |
| ||
| Nausea | Gastrointestinal disorders | NCI-CTCAE version 3. |
| ||
| Anorexia | Metabolism and nutrition disorders | NCI-CTCAE version 3. |
| ||
| Constipation | General disorders | NCI-CTCAE version 3. |
| ||
| Taste alteration (dysgeusia) | Gastrointestinal disorders | NCI-CTCAE version 3. |
| ||
| Vomiting | Gastrointestinal disorders | NCI-CTCAE version 3. |
| ||
| Mucositis | Gastrointestinal disorders | NCI-CTCAE version 3. |
| ||
| Heartburn | Gastrointestinal disorders | NCI-CTCAE version 3. |
| ||
| Rash (acne/acneiform) | Skin and subcutaneous tissue disorders | NCI-CTCAE version 3. |
| ||
| Rash (desquamation) | Skin and subcutaneous tissue disorders | NCI-CTCAE version 3. |
| ||
| Dry skin | Skin and subcutaneous tissue disorders | NCI-CTCAE version 3. |
| ||
| Alopecia | Skin and subcutaneous tissue disorders | NCI-CTCAE version 3. |
| ||
| Dermatology/Skin (other) | Skin and subcutaneous tissue disorders | NCI-CTCAE version 3. |
| ||
| Itching | Skin and subcutaneous tissue disorders | NCI-CTCAE version 3. |
| ||
| Fatigue | Gastrointestinal disorders | NCI-CTCAE version 3. |
| ||
| Weight loss | Eye disorders | NCI-CTCAE version 3. |
| ||
| Chills | General disorders | NCI-CTCAE version 3. |
| ||
| Joint pain | Musculoskeletal and connective tissue disorders | NCI-CTCAE version 3. |
| ||
| Back pain | Musculoskeletal and connective tissue disorders | NCI-CTCAE version 3. |
| ||
| Limb pain | Musculoskeletal and connective tissue disorders | NCI-CTCAE version 3. |
| ||
| Headache | Nervous system disorders | NCI-CTCAE version 3. |
| ||
| Check pain | Respiratory, thoracic and mediastinal disorders | NCI-CTCAE version 3. |
| ||
| Abdominal pain | Gastrointestinal disorders | NCI-CTCAE version 3. |
| ||
| Shortness of breath | Respiratory, thoracic and mediastinal disorders | NCI-CTCAE version 3. |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | NCI-CTCAE version 3. |
| ||
| Nasal cavity/paranasal sinus reactions | Respiratory, thoracic and mediastinal disorders | NCI-CTCAE version 3. |
| ||
| Pulmonary (other) | Respiratory, thoracic and mediastinal disorders | NCI-CTCAE version 3. |
| ||
| Hyperglycemia | Metabolism and nutrition disorders | NCI-CTCAE version 3. |
| ||
| Hyponatremia | Metabolism and nutrition disorders | NCI-CTCAE version 3. |
| ||
| Serum glutamic pyruvic transaminase | Metabolism and nutrition disorders | NCI-CTCAE version 3. |
| ||
| Alkaline phosphase | Metabolism and nutrition disorders | NCI-CTCAE version 3. |
| ||
| AST, SGOT | Metabolism and nutrition disorders | NCI-CTCAE version 3. |
| ||
| Bilirubin | Metabolism and nutrition disorders | NCI-CTCAE version 3. |
| ||
| Magnesium, serum low | Metabolism and nutrition disorders | NCI-CTCAE version 3. |
| ||
| Albumin, serum low | Metabolism and nutrition disorders | NCI-CTCAE version 3. |
| ||
| Potassium, serum low | Metabolism and nutrition disorders | NCI-CTCAE version 3. |
| ||
| Sensory alteration | Nervous system disorders | NCI-CTCAE version 3. |
| ||
| Dizziness | Nervous system disorders | NCI-CTCAE version 3. |
| ||
| Mood alteration, depression | Psychiatric disorders | NCI-CTCAE version 3. |
| ||
| Anxiety | Psychiatric disorders | NCI-CTCAE version 3. |
| ||
| Hemoglobin | Blood and lymphatic system disorders | NCI-CTCAE version 3. |
| ||
| Leukocytes | Blood and lymphatic system disorders | NCI-CTCAE version 3. |
| ||
| Platelets | Blood and lymphatic system disorders | NCI-CTCAE version 3. |
| ||
| Visual alteration | Eye disorders | NCI-CTCAE version 3. |
| ||
| Dry eye syndrome | Eye disorders | NCI-CTCAE version 3. |
| ||
| Hemorrhage, nose | Respiratory, thoracic and mediastinal disorders | NCI-CTCAE version 3. |
| ||
| Edema, limb | General disorders | NCI-CTCAE version 3. |
| ||
| Allergic Rhinitis | Respiratory, thoracic and mediastinal disorders | NCI-CTCAE version 3. |
| ||
| Hypertension | Cardiac disorders | NCI-CTCAE version 3. |
|
Not provided
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Leora Horn, Principal Investigator | Vanderbilt-Ingram Cancer Center | leora.horn@vanderbilt.edu |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D002282 | Adenocarcinoma, Bronchiolo-Alveolar |
| D000077192 | Adenocarcinoma of Lung |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| D016190 | Carboplatin |
| D000069347 | Erlotinib Hydrochloride |
| D017239 | Paclitaxel |
| D020869 | Gene Expression Profiling |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D005821 | Genetic Techniques |
| D008919 | Investigative Techniques |
Not provided
Not provided
|
| Unknown or Not Reported |
|
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Participants |
|
|
|
| OG002 | Erlotinib | Erlotinib followed by paclitaxel + carboplatin (PC) or paclitaxel + carboplatin + bevacizumab (PC+B) in non-squamous cell at the time disease progression. bevacizumab: 15 mg/m2 given through a vein for every 3 weeks carboplatin: AUC = 6 given through a vein on day 1 of each cycle. erlotinib hydrochloride: 150 mg taken by mouth daily paclitaxel: 200 mg/m2 given through a vein on day 1 of each cycle. gene expression analysis: Blood and tissue collection. protein expression analysis: Blood and tissue collection. proteomic profiling: Blood and tissue collection. laboratory biomarker analysis: Blood and tissue collection. |
|
|