Dasatinib in Treating Patients With Relapsed Small Cell Lung Cancer

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 44

Inclusion Criteria

Histologically or cytologically confirmed small cell lung cancer (SCLC) (limited or extensive stage disease)
Progressive or recurrent disease after an initial response to first-line treatment with a platinum-based chemotherapy with or without concurrent definitive radiotherapy to the chest (chemotherapy must have been completed at least 90 days prior to documentation of relapse)
Measurable disease, defined as >= 1 unidimensionally measurable lesion >= 20 mm by conventional techniques OR >= 10 mm by spiral CT scan
Lesions that are not considered measurable include the following:
- Bone lesions
- Leptomeningeal disease
- Ascites
- Pleural or pericardial effusion
- Abdominal masses that are not confirmed and followed by imaging techniques
- Cystic lesions
- Tumor lesions situated in a previously irradiated area, unless progression after radiotherapy is documented in these lesions
No known brain metastases (previously treated brain metastases allowed provided they are neurologically stable for >= 4 weeks)
ECOG performance status 0-1
Platelet count >= 100,000/mm^3
Bilirubin =< 1.5 times upper limit of normal (ULN)
Creatinine =< 1.5 times ULN OR creatinine clearance >= 60 mL/min
AST =< 2.5 times ULN
Not pregnant or nursing
Negative pregnancy test
No significant cardiac disease, including any of the following:
- New York Heart Association class III-IV heart disease
- Myocardial infarction or ventricular tachyarrhythmia within the past 6 months
- Prolonged QTc > 480 msec (Fridericia correction)
- Major conduction abnormality (unless a cardiac pacemaker is present)
No more than 1 prior chemotherapy regimen
No prior dasatinib or compounds of similar chemical composition or similar biologic therapeutic activity including, but not limited to, any inhibitors of SRC, BCR-ABL, c-KIT, EPHA2, or PDGFRB kinases
At least 2 weeks since prior definitive or palliative radiotherapy (prior radiotherapy allowed in the context of combined modality treatment with curative intent for limited stage disease; prophylactic cranial radiotherapy; or palliative radiotherapy initially or at relapse)
At least 2 weeks since prior surgery and recovered
At least 1 week since prior and no concurrent agents with proarrhythmic potential
At least 1 week since prior and no concurrent CYP3A4 inhibitors or inducers
At least 1 week since prior and no concurrent grapefruit concentrate
No concurrent palliative radiotherapy
No concurrent hormones or other chemotherapeutic agents, except steroids for adrenal failure, hormones for noncancer-related conditions (e.g., insulin for diabetes), or intermittent dexamethasone as an antiemetic
No concurrent combination antiretroviral therapy for HIV-positive patients
No other concurrent chemotherapeutic or investigational agents
Fertile patients must use effective contraception during and for >= 6 weeks after completion of study therapy

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment (dasatinib)	dasatinib	Patients receive oral dasatinib twice daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measures

Name	Time	Method
6 Week Progression Free Survival	6 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Progression Free Survival (PFS)	Time from registration to progression (up to 3 years)	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	Assessed every 2 cycles (up to 3 years)	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 from registration to death (up to 3 years)	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	Assessed during treatment	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.

Dasatinib in Treating Patients With Relapsed Small Cell Lung Cancer

Recruitment & Eligibility

Study & Design

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