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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

Study Description
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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.


Condition or disease Intervention/treatment Phase
Lung Cancer Drug: Carboplatin Drug: erlotinib hydrochloride Drug: Paclitaxel Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : November 2004
Actual Primary Completion Date : August 2007
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 150 PRE
Erlotinib 150mg on days 1 and 2 of a 21 day cycle and Carboplatin AUC6 and Paclitaxel 200 mg/m2
 Drug: Carboplatin
Other Name: Carboplatin AUC6

Drug: erlotinib hydrochloride
150mg
Other Name: Erlotinib

Drug: Paclitaxel
200mg/m2
Experimental: 1,500 PRE
Erlotinib 1500mg on Days 1 and 2 of a 21 day cycle and Carboplatin AUC6 and Paclitaxel 200mg/m2
 Drug: Carboplatin
Other Name: Carboplatin AUC6

Drug: Paclitaxel
200mg/m2

Drug: erlotinib hydrochloride
1500mg
Other Name: Erlotinib
Experimental: 1,500 POST
Carboplatin AUC6, Paclitaxel 200 mg/m2 followed by Erlotinib 1500mg days 2 and 3.
 Drug: Carboplatin
Other Name: Carboplatin AUC6

Drug: Paclitaxel
200mg/m2

Drug: erlotinib hydrochloride
1500mg
Other Name: Erlotinib


Outcome Measures
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Primary Outcome Measures :
  1. Overall Response Rate [ Time Frame: after 6 cycles of chemotherapy ]
    Percentage of patients who experienced complete or partial response as defined by RECIST


Secondary Outcome Measures :
  1. Time to Progression [ Time Frame: after cycle 6 of chemotherapy ]
    Median number of months until disease progression


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00287989


Locations
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United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Charles M. Rudin, MD, PhD Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
More Information
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Publications of Results:

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Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT00287989    
Other Study ID Numbers: J0432
P30CA006973 ( U.S. NIH Grant/Contract )
JHOC-J0432
JHOC-WIRB-20041142
CDR0000455116 ( Other Identifier: other )
20-04-11-42 ( Other Identifier: JHM IRB )
First Posted: February 7, 2006    Key Record Dates
Results First Posted: December 6, 2018
Last Update Posted: December 6, 2018
Last Verified: November 2018
Keywords provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins:
recurrent non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Paclitaxel
 Carboplatin
Erlotinib Hydrochloride
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors
Enzyme Inhibitors