Dasatinib in Treating Patients With Relapsed Small Cell Lung Cancer
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 relapsed small cell lung cancer.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Dasatinib (NSC #732517, IND #73969) In Patients With Chemosensitive Relapsed Small Cell Lung Cancer|
- 6 Week Progression Free Survival [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Percentage of patients who were alive and progression free at 6-weeks. The 6-week progression free survival was estimated using the Kaplan Meier method.
Progressive Disease was defined by the Response Evaluation Criteria In Solid Tumors (RECIST) criteria as 20% increase in sum of longest diameter of target lesions.
- Progression Free Survival (PFS) [ Time Frame: Time from registration to progression (up to 3 years) ] [ Designated as safety issue: No ]
PFS was defined as the time from registration until disease progression or death, whichever occurs first. The median PFS with 95% CI was estimated using the Kaplan-Meier method.
Progression is defined as in the primary outcome measure.
- Response to Therapy [ Time Frame: Assessed every 2 cycles (up to 3 years) ] [ Designated as safety issue: No ]
Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria:
- Complete Response (CR): disappearance of all target lesions;
- Partial Response (PR) 30% decrease in sum of longest diameter of target lesions;
- Progressive Disease (PD): 20% increase in sum of longest diameter of target lesions;
- Stable Disease (SD): small changes that do not meet above criteria.
- Overall Survival [ Time Frame: Time from registration to death (up to 3 years) ] [ Designated as safety issue: No ]Overall survival (OS) was defined as the time from registration to death of any cause. Surviving patients were censored at the date of last follow-up. The median OS with 95% CI was estimated using the Kaplan Meier method.
- Number of Participants With Grade 3 or Higher Adverse Events [ Time Frame: Assessed during treatment ] [ Designated as safety issue: Yes ]
The National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 was used to evaluate toxicity.
Grade 1: mild; Grade 2: moderate; Grade 3: Severe; Grade 4: Life Threatening; Grade 5: Death.
|Study Start Date:||April 2007|
|Study Completion Date:||June 2010|
|Primary Completion Date:||February 2009 (Final data collection date for primary outcome measure)|
Pts receive oral dasatinib 70 mg twice daily
70 mg PO twice daily
- Determine the efficacy of dasatinib in patients with relapsed small cell lung cancer.
- Determine the objective response rate (complete and partial response) in patients treated with this drug.
- Determine the overall survival of patients treated with this drug.
- Determine the toxicity of this drug in these patients.
- Evaluate surrogate biologic markers (FAK, paxillin, and SRC phosphorylation) in peripheral mononuclear cells (PBMC) and VEGF and PDGF beta in serum.
OUTLINE: Patients receive oral dasatinib twice daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at least every 3 months for 1 year and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 56 patients will be accrued for this study.
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|Study Chair:||Antonius Miller, MD||Comprehensive Cancer Center Hematology/Oncology Wake Forest University|