Status:
COMPLETED
Dasatinib in Treating Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Non-small Cell Lung Cancer
Recurrent Non-small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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, stag...
Detailed Description
PRIMARY OBJECTIVES: 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. SECONDARY OBJECTIVES: I....
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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
- No history of allergic reactions to compounds of similar chemical or biological composition to dasatinib
- No heart rate-corrected QT interval (QTc) prolongation (i.e., QTC \>= 480 msec) or other significant ECG abnormalities that could lead to adverse effects if the QTc interval were prolonged
- No medical condition that impairs the ability to swallow, retain, or absorb dasatinib including, but not limited to, any of the following:
- Gastrointestinal tract disease resulting in an inability to take oral medication, requirement for IV alimentation, prior surgical procedures affecting absorption, active peptic ulcer disease
- No myocardial infarction or ventricular tachyarrhythmia within the past 6 months
- left ventricular ejection fraction (LVEF) normal
- No major conduction abnormality (unless cardiac pacemaker is present)
- No ongoing or active infection
- No history of significant bleeding disorder (congenital \[von Willebrand's disease\] or acquired \[antifactor VIII antibodies\])
- No psychiatric illness or social situation that would preclude study compliance
- No prior chemotherapy or biologic therapy for recurrent or metastatic non-small cell lung cancer
- Adjuvant cytotoxic chemotherapy after surgical resection or chemotherapy with radiation for locally advanced disease (curative intent) allowed provided disease recurrence \>= 3 months after completion of last chemotherapy dose
- Measurable disease must be outside the radiotherapy port OR clearly growing inside the port
- No prior radiotherapy to \>= 25% of the marrow-containing skeleton
- At least 7 days since prior and no concurrent medications that are inhibitors or inducers of CYP3A4
- At least 7 days since prior and no concurrent agents with proarrhythmic potential
- No other concurrent investigational agents
- No other concurrent anticancer agents or therapies
- No concurrent antiretroviral therapy for HIV-positive patients
- No concurrent systemic antacids (H2 receptor antagonists and proton pump inhibitors)
- Locally acting antacids allowed except for 2 hours before and after dasatinib administration
Exclusion
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00459342
Start Date
March 1 2007
End Date
April 1 2012
Last Update
March 5 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030