Overview

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