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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00459342
First received: April 9, 2007
Last updated: April 29, 2014
Last verified: December 2012

April 9, 2007
April 29, 2014
March 2007
April 2012   (final data collection date for primary outcome measure)
  • Number of Participants With Objective Response (Complete Response (CR) or Partial Response (PR)) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Objective response defined as participants with Complete Response (CR) or Partial Response (PR) evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. RECIST definitions are Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started. Response measured by tumor size on computed tomography scans and by metabolic activity on positron emission tomography scans.
  • Progression-free Survival (PFS) [ Time Frame: Time from start of treatment to time of progression or death, assessed at 2 months ] [ Designated as safety issue: No ]
    PFS is defined as the duration of time from start of treatment to time of progression or death.
  • Progression-free survival at 12 weeks
  • Objective response
Complete list of historical versions of study NCT00459342 on ClinicalTrials.gov Archive Site
  • Overall Survival [ Time Frame: Time from start of treatment to death from any cause, assessed up to 5 years ] [ Designated as safety issue: No ]
    Number of participants still living, measured from start of treatment to death from any cause, assessed up to 5 years using Kaplan-Meier.
  • Time to Progression [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Time in months from baseline assessment to disease progression or death for any reason, up to 5 years.
  • Epidermal growth factor receptor (EGFR) mutational status
  • EGFR copy number
  • pSrc expression levels
  • Toxicity
Not Provided
Not Provided
 
Dasatinib in Treating Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer
Phase II Study of Dasatinib in Non Small Cell Lung Cancer

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.

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. Determine the rate of response in patients treated with this drug. II. Examine the relationship between clinical response to this drug and epidermal growth factor receptor (EGFR) mutational status, EGFR copy number, and pSrc expression levels in pre-treatment tumor biopsies.

III. Determine the toxicity of this drug.

OUTLINE:

Patients received oral dasatinib twice daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

Previously obtained paraffin-embedded tumor tissue samples are analyzed by polymerase chain reaction and fluorescent in situ hybridization (FISH) for epidermal growth factor receptor and by immunohistochemistry for pSrc expression.

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • 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
Drug: dasatinib
Given orally
Other Names:
  • BMS-354825
  • Sprycel
Experimental: Arm I
Patients received oral dasatinib twice daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Intervention: Drug: dasatinib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
35
April 2012
April 2012   (final data collection date for primary outcome measure)

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
  • ECOG performance status (PS) 0-1 OR Karnofsky PS 60-100%
  • Life expectancy > 12 weeks
  • WBC >= 3,000/mm^3
  • Absolute neutrophil count >= 1,500/mm^3
  • Bilirubin =< 1.5 times upper limit of normal (ULN)
  • 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 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
  • 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00459342
NCI-2009-00225, NCI-2009-00225, CDR0000538668, 2006-0593, 2006-0593, 7798, N01CM62202, P30CA016672
Not Provided
National Cancer Institute (NCI)
National Cancer Institute (NCI)
Not Provided
Principal Investigator: Faye Johnson M.D. Anderson Cancer Center
National Cancer Institute (NCI)
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP