Dasatinib in Treating Patients With Advanced Lung Cancer That Is No Longer Responding to Erlotinib or Gefitinib
This study has been completed.
Sponsor:
Memorial Sloan-Kettering Cancer Center
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Drug: dasatinib |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 2 Trial of Dasatinib in Patients With Lung Adenocarcinoma With Acquired Resistance to Erlotinib or Gefitinib |
Resource links provided by NLM:
Further study details as provided by Memorial Sloan-Kettering Cancer Center:
Primary Outcome Measures:
- Proportion of confirmed tumor responses ( complete or partial response) as measured by RECIST [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ]
| Enrollment: | 22 |
| Study Start Date: | June 2006 |
| Study Completion Date: | September 2011 |
| Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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. |
Drug: dasatinib |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00570401
Locations
| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10065 | |
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
| Principal Investigator: | Vincent A. Miller, MD | Memorial Sloan-Kettering Cancer Center |
| Principal Investigator: | Gregory J. Riely, MD | Memorial Sloan-Kettering Cancer Center |
More Information
Additional Information:
Publications:
| Responsible Party: | Memorial Sloan-Kettering Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00570401 History of Changes |
| Obsolete Identifiers: | NCT00590057 |
| Other Study ID Numbers: | Mskcc 06-143, P30CA008748, MSKCC-06143, BMS-MSKCC-06143 |
| Study First Received: | December 7, 2007 |
| Last Updated: | April 29, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Memorial Sloan-Kettering Cancer Center:
|
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 |
Additional relevant MeSH terms:
|
Adenocarcinoma Lung Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Lung Diseases |
Respiratory Tract Diseases Gefitinib Erlotinib Dasatinib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 17, 2013