Dasatinib in Treating Patients With Relapsed Small Cell Lung Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00470054
First received: May 3, 2007
Last updated: June 18, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Extensive Stage Small Cell Lung Cancer
Limited Stage Small Cell Lung Cancer
Recurrent Small Cell Lung Cancer
Drug: dasatinib
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Dasatinib (NSC #732517) in Patients With Chemo-Sensitive Relapsed Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 6 Week Progression Free Survival [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

    Percentage of patients who were alive and progression free at 6-weeks. The 6-week progression free survival was estimated using the Kaplan Meier method.

    Progressive Disease was defined by the Response Evaluation Criteria In Solid Tumors (RECIST) criteria as 20% increase in sum of longest diameter of target lesions.



Secondary Outcome Measures:
  • Progression Free Survival (PFS) [ Time Frame: Time from registration to progression (up to 3 years) ] [ Designated as safety issue: No ]

    PFS was defined as the time from registration until disease progression or death, whichever occurs first. The median PFS with 95% CI was estimated using the Kaplan-Meier method.

    Progression is defined as in the primary outcome measure.


  • Response to Therapy [ Time Frame: Assessed every 2 cycles (up to 3 years) ] [ Designated as safety issue: No ]

    Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria:

    • Complete Response (CR): disappearance of all target lesions;
    • Partial Response (PR) 30% decrease in sum of longest diameter of target lesions;
    • Progressive Disease (PD): 20% increase in sum of longest diameter of target lesions;
    • Stable Disease (SD): small changes that do not meet above criteria.

  • Overall Survival [ Time Frame: Time from registration to death (up to 3 years) ] [ Designated as safety issue: No ]
    Overall survival (OS) was defined as the time from registration to death of any cause. Surviving patients were censored at the date of last follow-up. The median OS with 95% CI was estimated using the Kaplan Meier method.

  • Number of Participants With Grade 3 or Higher Adverse Events [ Time Frame: Assessed during treatment ] [ Designated as safety issue: Yes ]

    The National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 was used to evaluate toxicity.

    Grade 1: mild; Grade 2: moderate; Grade 3: Severe; Grade 4: Life Threatening; Grade 5: Death.



Enrollment: 44
Study Start Date: April 2007
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (dasatinib)
Patients receive oral dasatinib twice daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Drug: dasatinib
Given PO
Other Names:
  • BMS-354825
  • Sprycel

Detailed Description:

PRIMARY OBJECTIVE I. Determine the efficacy of dasatinib in patients with relapsed small cell lung cancer.

SECONDARY OBJECTIVE II. Determine the objective response rate (complete and partial response) in patients treated with this drug.

III. Determine the overall survival of patients treated with this drug. IV. Determine the toxicity of this drug in these patients.

OUTLINE:

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

After completion of study treatment, patients are followed at least every 3 months for 1 year and then every 6 months for 3 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • No prior dasatinib or compounds of similar chemical composition or similar biologic therapeutic activity including, but not limited to, any inhibitors of SRC, BCR-ABL, c-KIT, EPHA2, or PDGFRB kinases
  • At least 2 weeks since prior definitive or palliative radiotherapy (prior radiotherapy allowed in the context of combined modality treatment with curative intent for limited stage disease; prophylactic cranial radiotherapy; or palliative radiotherapy initially or at relapse)
  • At least 2 weeks since prior surgery and recovered
  • At least 1 week since prior and no concurrent agents with proarrhythmic potential
  • At least 1 week since prior and no concurrent CYP3A4 inhibitors or inducers
  • At least 1 week since prior and no concurrent grapefruit concentrate
  • No concurrent palliative radiotherapy
  • No concurrent hormones or other chemotherapeutic agents, except steroids for adrenal failure, hormones for noncancer-related conditions (e.g., insulin for diabetes), or intermittent dexamethasone as an antiemetic
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No other concurrent chemotherapeutic or investigational agents
  • Fertile patients must use effective contraception during and for >= 6 weeks after completion of study therapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00470054

Locations
United States, Illinois
Cancer and Leukemia Group B
Chicago, Illinois, United States, 60606
Sponsors and Collaborators
Investigators
Principal Investigator: Antonius Miller Cancer and Leukemia Group B
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00470054     History of Changes
Other Study ID Numbers: NCI-2009-00467, NCI-2009-00467, CDR0000543528, CALGB 30602, CALGB-30602, P30CA014236, U10CA031946
Study First Received: May 3, 2007
Results First Received: January 2, 2013
Last Updated: June 18, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Dasatinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014