Dasatinib in Treating Patients With Relapsed Small Cell Lung Cancer

Completed · Phase 2

Conditions studied: Extensive Stage Small Cell Lung Cancer, Limited Stage Small Cell Lung Cancer, Recurrent Small Cell Lung Cancer

In brief

This phase II trial is studying how well dasatinib works in treating patients with relapse small cell lung cancer. Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Key facts

Study ID

NCT00470054

Run by

National Cancer Institute (NCI)

People needed

44

Starts

2007-04-01

Expected to finish

2013-04-01

Last updated by the study team

2015-05-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• Cancer and Leukemia Group B — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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