Dasatinib in Treating Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer

Completed · Phase 2

Conditions studied: 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

In brief

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.

Key facts

Study ID

NCT00459342

Run by

National Cancer Institute (NCI)

People needed

35

Starts

2007-03-01

Expected to finish

2012-04-01

Last updated by the study team

2019-03-05

Who can join

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

You may qualify if…

• Platelet count >= 100,000/mm\^3
• Histologically or cytologically confirmed non-small cell lung cancer meeting 1 of the following criteria:
• Stage IV disease
• Stage IIIB disease with pleural effusion
• Recurrent disease after surgery or radiotherapy
• Measurable disease, defined as >= 1 lesion that can be accurately measured in at least 1 dimension (longest diameter to be recorded) >= 20 mm by conventional techniques OR >= 10 mm by spiral CT scan
• Previously treated brain metastasis allowed, provided there is no bleeding, no midline shift, no need for steroids or anti-convulsants, and no symptoms
• Must agree to obtain residual tumor tissue available from the existing diagnostic biopsy tumor tissue
• Eastern cooperative oncology group (ECOG) performance status (PS) 0-1 OR Karnofsky PS 60-100%
• Life expectancy > 12 weeks
• White blood cell (WBC) >= 3,000/mm\^3
• Absolute neutrophil count >= 1,500/mm\^3
• Bilirubin =< 1.5 times upper limit of normal (ULN)
• Aspartate aminotransferase (AST) and ALT =< 2.5 times ULN
• Creatinine =< 3 times ULN OR Creatinine clearance >= 60 mL/min
• No uncontrolled congestive heart failure or potentially life-threatening arrhythmia
• No angina at rest
• No neuropathy >= grade 2
• No chronic diarrhea or history of inflammatory bowel disease
• No history of pulmonary fibrosis (other than in an irradiated field)
• No other concurrent serious medical illness
• O2 saturation > 92% on room air
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

Where it is running

• M D Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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