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Dasatinib in Treating Patients With Relapsed Small Cell Lung Cancer
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), January 2009
Sponsors and Collaborators: Cancer and Leukemia Group B
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00470054
  Purpose

RATIONALE: Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase II trial is studying how well dasatinib works in treating patients with relapsed small cell lung cancer.


Condition Intervention Phase
Lung Cancer
Drug: dasatinib
Phase II

MedlinePlus related topics: Cancer Lung Cancer
Drug Information available for: Dasatinib
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase II Study of Dasatinib (NSC #732517, IND #73969) In Patients With Chemosensitve Relapsed Small Cell Lung Cancer

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

Primary Outcome Measures:
  • Progression-free survival at 6 weeks [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response rate [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Adverse events [ Designated as safety issue: Yes ]

Estimated Enrollment: 56
Study Start Date: April 2007
Estimated Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Determine the efficacy of dasatinib in patients with relapsed small cell lung cancer.

Secondary

  • Determine the objective response rate (complete and partial response) in patients treated with this drug.
  • Determine the overall survival of patients treated with this drug.
  • 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.

PROJECTED ACCRUAL: A total of 56 patients will be accrued for this study.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-1
  • Platelet count ≥ 100,000/mm^3
  • WBC ≥ 1,500/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
  • Fertile patients must use effective contraception during and for ≥ 6 weeks after completion of study therapy
  • 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)

PRIOR CONCURRENT THERAPY:

  • 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 PDGFRβ 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00470054

  Show 89 Study Locations
Sponsors and Collaborators
Cancer and Leukemia Group B
Investigators
Study Chair: Nithya Ramnath, MD Roswell Park Cancer Institute
Investigator: Gregory A. Otterson, MD Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000543528, CALGB-30602
Study First Received: May 3, 2007
Last Updated: January 6, 2009
ClinicalTrials.gov Identifier: NCT00470054  
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
extensive stage small cell lung cancer
limited stage small cell lung cancer
recurrent small cell lung cancer

Study placed in the following topic categories:
Thoracic Neoplasms
Carcinoma, Neuroendocrine
Recurrence
Carcinoma
Neuroendocrine Tumors
Carcinoma, Small Cell
Neuroectodermal Tumors
Respiratory Tract Diseases
Lung Neoplasms
Dasatinib
Lung Diseases
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Adenocarcinoma
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Neoplasms, Nerve Tissue
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009