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Erlotinib, Paclitaxel, and Carboplatin in Treating Patients With Stage III, Stage IV, or Recurrent Non-Small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT00287989
Recruitment Status : Completed
First Posted : February 7, 2006
Results First Posted : December 6, 2018
Last Update Posted : December 6, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Tracking Information
First Submitted Date  ICMJE February 6, 2006
First Posted Date  ICMJE February 7, 2006
Results First Submitted Date  ICMJE March 20, 2017
Results First Posted Date  ICMJE December 6, 2018
Last Update Posted Date December 6, 2018
Study Start Date  ICMJE November 2004
Actual Primary Completion Date August 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 12, 2018)
Overall Response Rate [ Time Frame: after 6 cycles of chemotherapy ]
Percentage of patients who experienced complete or partial response as defined by RECIST
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 12, 2018)
Time to Progression [ Time Frame: after cycle 6 of chemotherapy ]
Median number of months until disease progression
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 Erlotinib, Paclitaxel, and Carboplatin in Treating Patients With Stage III, Stage IV, or Recurrent Non-Small Cell Lung Cancer
Official Title  ICMJE A Randomized Phase II Trial Comparing Two Doses of Pulsed Erlotinib Prechemotherapy (PEP-C) in Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Brief Summary

RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving erlotinib together with paclitaxel and carboplatin may kill more tumor cells.

PURPOSE: This randomized phase II trial is studying two different doses of erlotinib when given together with paclitaxel and carboplatin to compare how well they work in treating patients with stage III, stage IV, or recurrent non-small cell lung cancer.

Detailed Description

OBJECTIVES:

  • Compare the major objective response (complete and partial response) rates in patients with stage IIIB or IV or recurrent non-small cell lung cancer treated with high- versus low-dose erlotinib hydrochloride combined with paclitaxel and carboplatin.
  • Compare the duration of response, time to progression, and survival of patients treated with these regimens.
  • Characterize and compare the toxicities of these regimens.
  • Determine the recommended phase III dose of erlotinib hydrochloride.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to gender. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive oral high-dose erlotinib hydrochloride on days 1 and 2. Patients also receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 3.
  • Arm II: Patients receive oral low-dose erlotinib hydrochloride, paclitaxel, and carboplatin as in arm I.

In both arms, treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 58 patients will be accrued for this study.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Lung Cancer
Intervention  ICMJE
  • Drug: Carboplatin
    Other Name: Carboplatin AUC6
  • Drug: erlotinib hydrochloride
    150mg
    Other Name: Erlotinib
  • Drug: Paclitaxel
    200mg/m2
  • Drug: erlotinib hydrochloride
    1500mg
    Other Name: Erlotinib
Study Arms  ICMJE
  • Experimental: 150 PRE
    Erlotinib 150mg on days 1 and 2 of a 21 day cycle and Carboplatin AUC6 and Paclitaxel 200 mg/m2
    Interventions:
    • Drug: Carboplatin
    • Drug: erlotinib hydrochloride
    • Drug: Paclitaxel
  • Experimental: 1,500 PRE
    Erlotinib 1500mg on Days 1 and 2 of a 21 day cycle and Carboplatin AUC6 and Paclitaxel 200mg/m2
    Interventions:
    • Drug: Carboplatin
    • Drug: Paclitaxel
    • Drug: erlotinib hydrochloride
  • Experimental: 1,500 POST
    Carboplatin AUC6, Paclitaxel 200 mg/m2 followed by Erlotinib 1500mg days 2 and 3.
    Interventions:
    • Drug: Carboplatin
    • Drug: Paclitaxel
    • Drug: erlotinib hydrochloride
Publications * Riely GJ, Rizvi NA, Kris MG, Milton DT, Solit DB, Rosen N, Senturk E, Azzoli CG, Brahmer JR, Sirotnak FM, Seshan VE, Fogle M, Ginsberg M, Miller VA, Rudin CM. Randomized phase II study of pulse erlotinib before or after carboplatin and paclitaxel in current or former smokers with advanced non-small-cell lung cancer. J Clin Oncol. 2009 Jan 10;27(2):264-70. doi: 10.1200/JCO.2008.17.4656. Epub 2008 Dec 1.

*   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: November 12, 2018)
86
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE May 2009
Actual Primary Completion Date August 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

DISEASE CHARACTERISTICS:

  • Pathologically confirmed non-small cell lung cancer

    • Stage IIIB or IV or recurrent disease
  • Measurable or evaluable indicator lesions
  • Must have smoked ≥ 100 cigarettes in his/her lifetime

PATIENT CHARACTERISTICS:

  • Karnofsky performance status 70-100%
  • WBC ≥ 4,000/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 50 mL/min
  • Bilirubin ≤ 1.0 mg/dL
  • AST ≤ 2.5 times upper limit of normal (ULN)
  • Alkaline phosphatase ≤ 2.5 times ULN
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for ≥ 1 week after completion of study treatment
  • No gastrointestinal tract disease or inability to take oral medication
  • No prior malignancy within the past 2 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
  • No other active medical problems, including severe infection, unstable angina, or myocardial infarction within the past 6 months
  • No poorly controlled hypertension or severe malnutrition
  • No New York Heart Association class III or IV congestive heart failure or serious cardiac arrhythmia requiring medication except chronic atrial arrhythmia (i.e., atrial fibrillation or paroxysmal supraventricular tachycardia)

PRIOR CONCURRENT THERAPY:

  • At least 3 weeks since prior radiotherapy to major bone marrow-containing sites
  • No prior chemotherapy for advanced non-small cell lung cancer
  • No prior agents directed at the epidermal growth factor receptor (EGFR)/HER axis (e.g., gefitinib, cetuximab, or trastuzumab [Herceptin®])
  • No prior surgical procedure resulting in abnormal absorption of oral medications
  • No concurrent surgical resection, palliative radiotherapy, or hormonal therapy
  • No other concurrent anticancer therapy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 120 Years   (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 NCT00287989
Other Study ID Numbers  ICMJE J0432
P30CA006973 ( U.S. NIH Grant/Contract )
JHOC-J0432
JHOC-WIRB-20041142
CDR0000455116 ( Other Identifier: other )
20-04-11-42 ( Other Identifier: JHM IRB )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Sponsor  ICMJE Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Charles M. Rudin, MD, PhD Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
PRS Account Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Verification Date November 2018

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