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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00570401
First received: December 7, 2007
Last updated: April 29, 2013
Last verified: April 2013

December 7, 2007
April 29, 2013
June 2006
September 2011   (final data collection date for primary outcome measure)
Proportion of confirmed tumor responses ( complete or partial response) as measured by RECIST [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Proportion of confirmed tumor responses ( complete or partial response) as measured by RECIST
Complete list of historical versions of study NCT00570401 on ClinicalTrials.gov Archive Site
  • Progression-free and overall survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Analysis of response rate by EGFR T790M mutation status [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Toxicities as assessed by NCI-CTCAE v3.0 [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Progression-free and overall survival
  • Analysis of response rate by EGFR T790M mutation status
  • Toxicities as assessed by NCI-CTCAE v3.0
Not Provided
Not Provided
 
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.

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.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Lung Cancer
Drug: dasatinib
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.

Intervention: Drug: dasatinib
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
September 2011
September 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00570401
Mskcc 06-143, P30CA008748, MSKCC-06143, BMS-MSKCC-06143
Not Provided
Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Vincent A. Miller, MD Memorial Sloan-Kettering Cancer Center
Principal Investigator: Gregory J. Riely, MD Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP