Dasatinib in Treating Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer
Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. This phase II trial is studying how well dasatinib works in treating patients with stage IIIB, stage IV, or recurrent non-small cell lung cancer
Non-small Cell Lung Cancer
Recurrent Non-small Cell Lung Cancer
Stage IIIB Non-small Cell Lung Cancer
Stage IV Non-small Cell Lung Cancer
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Dasatinib in Non Small Cell Lung Cancer|
- Number of Participants With Objective Response (Complete Response (CR) or Partial Response (PR)) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Objective response defined as participants with Complete Response (CR) or Partial Response (PR) evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. RECIST definitions are Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started. Response measured by tumor size on computed tomography scans and by metabolic activity on positron emission tomography scans.
- Progression-free Survival (PFS) [ Time Frame: Time from start of treatment to time of progression or death, assessed at 2 months ] [ Designated as safety issue: No ]PFS is defined as the duration of time from start of treatment to time of progression or death.
- Overall Survival [ Time Frame: Time from start of treatment to death from any cause, assessed up to 5 years ] [ Designated as safety issue: No ]Number of participants still living, measured from start of treatment to death from any cause, assessed up to 5 years using Kaplan-Meier.
- Time to Progression [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]Time in months from baseline assessment to disease progression or death for any reason, up to 5 years.
|Study Start Date:||March 2007|
|Study Completion Date:||April 2012|
|Primary Completion Date:||April 2012 (Final data collection date for primary outcome measure)|
Oral dasatinib 100 mg (two 50 mg tablets) twice daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
100 mg (two 50 mg tablets) given orally
I. Determine the progression-free survival at 12 weeks in patients with stage IIIB or IV or recurrent non-small cell lung cancer treated with dasatinib.
I. Determine the rate of response in patients treated with this drug. II. Examine the relationship between clinical response to this drug and epidermal growth factor receptor (EGFR) mutational status, EGFR copy number, and pSrc expression levels in pre-treatment tumor biopsies.
III. Determine the toxicity of this drug.
Patients received oral dasatinib twice daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Previously obtained paraffin-embedded tumor tissue samples are analyzed by polymerase chain reaction and fluorescent in situ hybridization (FISH) for epidermal growth factor receptor and by immunohistochemistry for pSrc expression.
|United States, Texas|
|M D Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Faye Johnson||M.D. Anderson Cancer Center|