| ID | Type | Description | Link |
|---|---|---|---|
| P30CA008748 | U.S. NIH Grant/Contract | View source | |
| MSKCC-06143 | |||
| BMS-MSKCC-06143 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
RATIONALE: Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying how well dasatinib works in treating patients with advanced lung cancer that is no longer responding to erlotinib or gefitinib.
OBJECTIVES:
Primary
Secondary
OUTLINE: Beginning 1 week after completion of erlotinib hydrochloride or gefitinib therapy, patients receive oral dasatinib twice daily. Treatment continues in the absence of disease progression or unacceptable toxicity.
Response is assessed by CT scan at 4 weeks, 8 weeks, and then every 8 weeks thereafter.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dasatinib | Experimental | Beginning 1 week after completion of erlotinib hydrochloride or gefitinib therapy, patients receive oral dasatinib twice daily. Treatment continues in the absence of disease progression or unacceptable toxicity. Response is assessed by CT scan at 4 weeks, 8 weeks, and then every 8 weeks thereafter. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dasatinib | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Determine the Overall Objective Response | To determine the overall response rate in patients with acquired erlotinib hydrochloride- or gefitinibresistant advanced adenocarcinoma of the lung treated with dasatinib using the RECIST criteria. Response and progression will be evaluated in this study using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee.22 Changes in only the largest diameter (uni-dimensional measurement) of the tumor lesions are used in the RECIST. | 2 years |
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DISEASE CHARACTERISTICS:
Pathologically confirmed adenocarcinoma of the lung
Previously treated with erlotinib hydrochloride or gefitinib for 6 months (at any time) and meets 1 of the following criteria:
Must have developed acquired resistance to erlotinib hydrochloride or gefitinib
Have previously undergone a biopsy of a site of progressive disease on protocol MSKCC 04-103* NOTE: *Results of this biopsy are not required to be enrolled on this trial
Measurable indicator lesions have not been previously irradiated
No CNS lesion that is symptomatic and/or requiring escalating doses of corticosteroids
PATIENT CHARACTERISTICS:
Karnofsky performance status 70-100%
WBC ≥ 3,000/mm³
Hemoglobin ≥ 9.0 g/dL
Platelet count ≥ 100,000/mm³
Total bilirubin ≤ 2.0 mg/dL
AST and ALT ≤ 2.5 times upper limit of normal
Creatinine ≤ 2 mg/dL or creatinine clearance ≥ 55 mL/min
QTc < 450 msec
Able to take oral medications
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for at least 4 weeks after study drug is stopped
No significant medical history or unstable medical condition, including any of the following:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Vincent A. Miller, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Gregory J. Riely, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10065 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21623279 | Result | Johnson ML, Riely GJ, Rizvi NA, Azzoli CG, Kris MG, Sima CS, Ginsberg MS, Pao W, Miller VA. Phase II trial of dasatinib for patients with acquired resistance to treatment with the epidermal growth factor receptor tyrosine kinase inhibitors erlotinib or gefitinib. J Thorac Oncol. 2011 Jun;6(6):1128-31. doi: 10.1097/JTO.0b013e3182161508. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dasatinib | Dasatinib in Patients with Lung Adenocarcinoma Receiving Erlotinib with Acquired Resistance to EGFR Tyrosine Kinase Inhibitors (TKIs) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dasatinib | Dasatinib in Patients with Lung Adenocarcinoma Receiving Erlotinib with Acquired Resistance to EGFR Tyrosine Kinase Inhibitors (TKIs) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 | Determine the Overall Objective Response | To determine the overall response rate in patients with acquired erlotinib hydrochloride- or gefitinibresistant advanced adenocarcinoma of the lung treated with dasatinib using the RECIST criteria. Response and progression will be evaluated in this study using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee.22 Changes in only the largest diameter (uni-dimensional measurement) of the tumor lesions are used in the RECIST. | Posted | Number | participants | 2 years |
|
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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 | Dasatinib | Dasatinib in Patients with Lung Adenocarcinoma Receiving Erlotinib with Acquired Resistance to EGFR Tyrosine Kinase Inhibitors (TKIs) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | CTC-3.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Albumin, low (hypoalbuminemia) | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Gregory Riely | Memorial Sloan Kettering Cancer Center | 646-888-4199 | rielyg@mskcc.org |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D000077192 | Adenocarcinoma of Lung |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000069439 | Dasatinib |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| 12 |
| 21 |
| 15 |
| 21 |
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | CTC-3.0 | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTC-3.0 | Systematic Assessment |
|
| Infection | Infections and infestations | CTC-3.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTC-3.0 | Systematic Assessment |
|
| Small intestinal obstruction | Gastrointestinal disorders | CTC-3.0 | Systematic Assessment |
|
| Back pain | General disorders | CTC-3.0 | Systematic Assessment |
|
| Pleuritic pain | General disorders | CTC-3.0 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTC-3.0 | Systematic Assessment |
|
| Thrombosis | Respiratory, thoracic and mediastinal disorders | CTC-3.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTC-3.0 | Systematic Assessment |
|
| Alkaline phosphatase | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
|
| ALT, SGPT | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
|
| Bilirubin (hyperbilirubinemia) | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTC-3.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTC-3.0 | Systematic Assessment |
|
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | CTC-3.0 | Systematic Assessment |
|
| Fatigue (asthenia, lethargy, malaise) | General disorders | CTC-3.0 | Systematic Assessment |
|
| Glucose, high (hyperglycemia) | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
|
| Hemoglobin | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
|
| Leukocytes (total WBC) | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTC-3.0 | Systematic Assessment |
|
| Neutrophils/granulocytes (ANC/AGC) | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
|
| Potassium, high (hyperkalemia) | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
|
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| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |