- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00570401
Dasatinib in Treating Patients With Advanced Lung Cancer That Is No Longer Responding to Erlotinib or Gefitinib
A Phase 2 Trial of Dasatinib in Patients With Lung Adenocarcinoma With Acquired Resistance to Erlotinib or Gefitinib
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.
Study Overview
Detailed Description
OBJECTIVES:
Primary
- To determine the overall response rate (complete response and partial response) in patients with acquired erlotinib hydrochloride- or gefitinib-resistant advanced adenocarcinoma of the lung treated with dasatinib.
Secondary
- To determine the progression-free survival and overall survival of patients treated with this drug.
- To determine the overall response rate in patients with EGFR T790M lung adenocarcinomas treated with this drug.
- To determine the progression-free survival and overall survival of patients with EGFR T790M lung adenocarcinomas treated with this drug.
- To determine the toxicity profile of dasatinib in these patients.
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10065
- Memorial Sloan-Kettering Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
Pathologically confirmed adenocarcinoma of the lung
- Advanced disease
Previously treated with erlotinib hydrochloride or gefitinib for 6 months (at any time) and meets 1 of the following criteria:
- Previously received treatment with erlotinib hydrochloride or gefitinib* and had a radiographic partial or complete response to treatment with erlotinib hydrochloride or gefitinib as defined by RECIST or WHO criteria
- Documented mutation in EGFR from tumor DNA NOTE: *Patients may have received other treatments subsequently including radiation or chemotherapy
Must have developed acquired resistance to erlotinib hydrochloride or gefitinib
- Radiographic evidence of disease progression during treatment with 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:
- History of diagnosed congenital long QT syndrome
- Ventricular arrhythmia
- Congestive heart failure
- Recent myocardial infarction
- Unstable angina
- Active infection
- Uncontrolled hypertension
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- At least 3 weeks since prior cytotoxic chemotherapy
- At least 3 weeks since prior radiation therapy to a major bone-marrow containing area
- At least 7 days since prior quinidine, procainamide, disopyramide, amiodarone, sotalol, ibutilide, dofetilide, erythromycin, clarithromycin, chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide, cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone, halofantrine, levomethadyl, pentamidine, sparfloxacin, or lidoflazine
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Dasatinib
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Determine the Overall Objective Response
Time Frame: 2 years
|
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
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Vincent A. Miller, MD, Memorial Sloan Kettering Cancer Center
- Principal Investigator: Gregory J. Riely, MD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Mskcc 06-143
- P30CA008748 (U.S. NIH Grant/Contract)
- MSKCC-06143
- BMS-MSKCC-06143
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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