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A Phase 2 Trial of Dasatinib in Patients With Lung Adenocarcinoma With Acquired Resistance to Erlotinib or Gefitinib


Phase 2
18 Years
N/A
Not Enrolling
Both
Lung Cancer

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Trial Information

A Phase 2 Trial of Dasatinib in Patients With Lung Adenocarcinoma With Acquired Resistance to Erlotinib or Gefitinib


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Proportion of confirmed tumor responses ( complete or partial response) as measured by RECIST

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Vincent A. Miller, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

Mskcc 06-143

NCT ID:

NCT00570401

Start Date:

June 2006

Completion Date:

September 2011

Related Keywords:

  • Lung Cancer
  • adenocarcinoma of the lung
  • stage IIIA non-small cell lung cancer
  • stage IIIB non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • recurrent non-small cell lung cancer
  • Adenocarcinoma
  • Lung Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021