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

Primary Purpose

Lung Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Carboplatin
erlotinib hydrochloride
Paclitaxel
erlotinib hydrochloride
Sponsored by
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring recurrent non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
  • Memorial Sloan-Kettering Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

150 PRE

1,500 PRE

1,500 POST

Arm Description

Erlotinib 150mg on days 1 and 2 of a 21 day cycle and Carboplatin AUC6 and Paclitaxel 200 mg/m2

Erlotinib 1500mg on Days 1 and 2 of a 21 day cycle and Carboplatin AUC6 and Paclitaxel 200mg/m2

Carboplatin AUC6, Paclitaxel 200 mg/m2 followed by Erlotinib 1500mg days 2 and 3.

Outcomes

Primary Outcome Measures

Overall Response Rate
Percentage of patients who experienced complete or partial response as defined by RECIST

Secondary Outcome Measures

Time to Progression
Median number of months until disease progression

Full Information

First Posted
February 6, 2006
Last Updated
November 12, 2018
Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00287989
Brief Title
Erlotinib, Paclitaxel, and Carboplatin in Treating Patients With Stage III, Stage IV, or Recurrent Non-Small Cell Lung Cancer
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 Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
May 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
recurrent non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Allocation
Randomized
Enrollment
86 (Actual)

8. Arms, Groups, and Interventions

Arm Title
150 PRE
Arm Type
Experimental
Arm Description
Erlotinib 150mg on days 1 and 2 of a 21 day cycle and Carboplatin AUC6 and Paclitaxel 200 mg/m2
Arm Title
1,500 PRE
Arm Type
Experimental
Arm Description
Erlotinib 1500mg on Days 1 and 2 of a 21 day cycle and Carboplatin AUC6 and Paclitaxel 200mg/m2
Arm Title
1,500 POST
Arm Type
Experimental
Arm Description
Carboplatin AUC6, Paclitaxel 200 mg/m2 followed by Erlotinib 1500mg days 2 and 3.
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Other Intervention Name(s)
Carboplatin AUC6
Intervention Type
Drug
Intervention Name(s)
erlotinib hydrochloride
Other Intervention Name(s)
Erlotinib
Intervention Description
150mg
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
200mg/m2
Intervention Type
Drug
Intervention Name(s)
erlotinib hydrochloride
Other Intervention Name(s)
Erlotinib
Intervention Description
1500mg
Primary Outcome Measure Information:
Title
Overall Response Rate
Description
Percentage of patients who experienced complete or partial response as defined by RECIST
Time Frame
after 6 cycles of chemotherapy
Secondary Outcome Measure Information:
Title
Time to Progression
Description
Median number of months until disease progression
Time Frame
after cycle 6 of chemotherapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles M. Rudin, MD, PhD
Organizational Affiliation
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231-2410
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19047285
Citation
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.
Results Reference
result

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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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