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

This study has been completed.

Sponsor:

Collaborator:

National Cancer Institute (NCI)

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

History of Changes

Tracking Information

First Received Date ^ICMJE

December 7, 2007

Last Updated Date

April 29, 2013

Start Date ^ICMJE

June 2006

Primary Completion Date

September 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Proportion of confirmed tumor responses ( complete or partial response) as measured by RECIST [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

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

Change History

Complete list of historical versions of study NCT00570401 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Progression-free and overall survival
Analysis of response rate by EGFR T790M mutation status
Toxicities as assessed by NCI-CTCAE v3.0

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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.

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 ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Lung Cancer

Intervention ^ICMJE

Drug: dasatinib

Study Arm (s)

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

Publications *

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.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

September 2011

Primary Completion Date

September 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00570401

Other Study ID Numbers ^ICMJE

Mskcc 06-143, P30CA008748, MSKCC-06143, BMS-MSKCC-06143

Has Data Monitoring Committee

Not Provided

Responsible Party

Memorial Sloan-Kettering Cancer Center

Study Sponsor ^ICMJE

Memorial Sloan-Kettering Cancer Center

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Principal Investigator:	Vincent A. Miller, MD	Memorial Sloan-Kettering Cancer Center
Principal Investigator:	Gregory J. Riely, MD	Memorial Sloan-Kettering Cancer Center

Information Provided By

Memorial Sloan-Kettering Cancer Center

Verification Date

April 2013

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

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