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

NCT00570401 | Completed Phase 2 Results

• 4 other identifiers: Mskcc 06-143P30CA008748MSKCC-06143BMS-MSKCC-06143
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Determine the Overall Objective Response

  To determine the overall response rate in patients with acquired erlotinib hydrochloride- or gefitinibresistant advanced adenocarcinoma of the lung treated with dasatinib using the RECIST criteria. Response and progression will be evaluated in this study using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee.22 Changes in only the largest diameter (uni-dimensional measurement) of the tumor lesions are used in the RECIST.

  2 years

Study Arms (1)

Dasatinib

EXPERIMENTAL

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.

Drug: dasatinib

Interventions

dasatinib DRUG

Dasatinib

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Publications (1)

• 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.

  PMID: 21623279 RESULT

MeSH Terms

Conditions

Lung Neoplasms; Adenocarcinoma of Lung; Carcinoma, Non-Small-Cell Lung

Interventions

Dasatinib

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Results Point of Contact

• Title: Dr. Gregory Riely
• Organization: Memorial Sloan Kettering Cancer Center

rielyg@mskcc.org

646-888-4199

Study Officials

• Vincent A. Miller, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

• Gregory J. Riely, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2007
• First Posted: December 10, 2007
• Study Start: June 1, 2006
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: January 22, 2016
• Results First Posted: January 22, 2016

Record last verified: 2015-12

Locations

US (1)