Dasatinib in Treating Patients With Advanced Lung Cancer That Is No Longer Responding to Erlotinib or Gefitinib

• Status: Completed
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Dasatinib; Erlotinib Hydrochloride; Gefitinib

Criteria

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