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

NCT00459342 | Completed Phase 2 Results

• 6 other identifiers: NCI-2009-00225CDR00005386682006-05937798N01CM62202P30CA016672
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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, stage IV, or recurrent non-small cell lung cancer.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Objective Response (Complete Response (CR) or Partial Response (PR))

  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.

  12 weeks

• Progression-free Survival (PFS)

  Progression-free survival (PFS) is defined as the duration of time from start of treatment to time of progression or death.

  Time from start of treatment to time of progression or death, assessed at 2 months

Other Outcomes (4)

• Time to Progression (TTP)

  Time from start of treatment to time of progression or death, assessed radiographically every 6 weeks

• Epidermal Growth Factor Receptor (EGFR) Mutational Status

  Baseline

• Epidermal Growth Factor Receptor (EGFR) Copy Number

  Baseline

Study Arms (1)

Arm I

EXPERIMENTAL

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

Drug: dasatinib

Interventions

dasatinib DRUG

Given orally

Also known as: BMS-354825, Sprycel

Arm I

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Dasatinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Results Point of Contact

• Title: Faye Johnson, MD / Associate Professor
• Organization: The University of Texas (UT) MD Anderson Cancer Center

fmjohns@mdanderson.org

713-792-7734

Study Officials

• Faye Johnson

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2007
• First Posted: April 11, 2007
• Study Start: March 1, 2007
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: March 5, 2019
• Results First Posted: December 24, 2013

Record last verified: 2019-02

Locations

US (1)