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Sorafenib in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT00098540
Recruitment Status : Completed
First Posted : December 8, 2004
Last Update Posted : December 29, 2016
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Tracking Information
First Submitted Date  ICMJE December 7, 2004
First Posted Date  ICMJE December 8, 2004
Last Update Posted Date December 29, 2016
Study Start Date  ICMJE December 2004
Actual Primary Completion Date May 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 13, 2012)
Confirmed tumor response according to RECIST criteria [ Time Frame: Up to 5 years ]
The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated using the Duffy-Santner approach.
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00098540 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 13, 2012)
  • Progression-free survival [ Time Frame: At 24 weeks ]
    The proportion of patients who are progression-free at 24-weeks will be computed and binomial confidence intervals for the true success proportion will be calculated.
  • Survival time [ Time Frame: From registration to death due to any cause, assessed up to 5 years ]
    Estimated using the method of Kaplan-Meier.
  • Time-to-disease progression [ Time Frame: From registration to documentation of disease progression, assessed up to 5 years ]
    Estimated using the method of Kaplan-Meier.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sorafenib in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Official Title  ICMJE Phase II Study of the Raf Kinase Inhibitor BAY43-9006 in Patients With Advanced Non-Small Cell Lung Cancer
Brief Summary This phase II trial is studying how well sorafenib works in treating patients with stage IIIB or stage IV non-small cell lung cancer. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It may also stop the growth of non-small cell lung cancer by blocking blood flow to the tumor.
Detailed Description

PRIMARY OBJECTIVES:

I. Determine the response rate in patients with stage IIIB or IV non-small cell lung cancer treated with sorafenib.

II. Determine the clinical toxic effects of this drug in these patients.

SECONDARY OBJECTIVES:

I. Determine the 24-week progression-free survival rate in patients treated with this drug.

II. Determine the overall survival of patients treated with this drug. III. Determine the time to disease progression in patients treated with this drug.

IV. Correlate predictive disease markers (K-ras and B-raf mutations and ERK/pERK, AKT/pAKT, and VEGFR2/p-VEGFR2 expression) in these patients with the activity of this drug.

OUTLINE: This is a multicenter study.

Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 6 months for up to 5 years.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Recurrent Non-small Cell Lung Cancer
  • Stage IIIB Non-small Cell Lung Cancer
  • Stage IV Non-small Cell Lung Cancer
Intervention  ICMJE
  • Drug: sorafenib tosylate
    Given orally
    Other Names:
    • BAY 43-9006
    • BAY 43-9006 Tosylate Salt
    • BAY 54-9085
    • Nexavar
    • SFN
  • Other: laboratory biomarker analysis
    Correlative studies
Study Arms  ICMJE Experimental: Treatment (sorafenib tosylate)
Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Interventions:
  • Drug: sorafenib tosylate
  • Other: laboratory biomarker analysis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 13, 2012)
46
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date May 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically or cytologically confirmed non-small cell lung cancer (NSCLC), meeting 1 of the following stage criteria:

    • Stage IIIB with pleural effusion
    • Stage IV
  • Measurable disease

    • At least 1 lesion ≥ 2.0 cm by conventional techniques OR ≥ 1.0 cm by spiral CT scan
    • The following are not considered measurable disease:

      • Bone lesions
      • Leptomeningeal disease
      • Ascites
      • Pleural/pericardial effusion
      • Inflammatory breast disease
      • Lymphangitis cutis/pulmonis
      • Abdominal masses not confirmed and followed by imaging techniques
      • Cystic lesions
  • No known brain metastases, even if treated and stable
  • Performance status - ECOG 0-2
  • At least 12 weeks
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 10 g/dL
  • No bleeding diathesis
  • Bilirubin ≤ 2 times upper limit of normal (ULN)
  • AST ≤ 3 times ULN (5 times ULN if hepatic metastasis present)
  • Creatinine ≤ 1.5 times ULN
  • No uncontrolled hypertension
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No known HIV positivity
  • HIV negative
  • Able to swallow tablets
  • No uncontrolled infection
  • No other severe underlying disease that would preclude study participation
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or adequately treated noninvasive carcinomas
  • No prior immunotherapy, biologic therapy, or gene therapy
  • No concurrent prophylactic colony-stimulating factors
  • At least 4 weeks since prior low-dose weekly chemotherapy as a radiosensitizer
  • No other prior chemotherapy for NSCLC
  • No concurrent chemotherapy
  • See Chemotherapy
  • At least 4 weeks since prior radiotherapy
  • No prior radiotherapy to ≥ 30% of bone marrow
  • No concurrent radiotherapy

    • Concurrent palliative radiotherapy to nontarget lesions (e.g., painful pre-existing bony metastasis) allowed
  • Prior adjuvant therapy allowed provided recurrent disease occurred > 6 months after completion of adjuvant therapy
  • No prior systemic therapy for NSCLC, including all novel targeted agents (e.g., gefitinib or erlotinib)
  • No concurrent therapeutic anticoagulation

    • Prophylactic anticoagulation (e.g., low-dose warfarin) for venous and arterial devices allowed provided PT, INR, and PTT requirements are met
  • No other concurrent anticancer agents or therapies
  • No other concurrent investigational agents or therapies
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00098540
Other Study ID Numbers  ICMJE NCI-2012-01818
N0326
NCCTG-N0326
CDR0000398203
U10CA025224 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Cancer Institute (NCI)
Study Sponsor  ICMJE National Cancer Institute (NCI)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Alex Adjei North Central Cancer Treatment Group
PRS Account National Cancer Institute (NCI)
Verification Date December 2016

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