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Last Modified: 6/27/2009     First Published: 7/23/2005  
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Phase II Randomized Study of Erlotinib With or Without Carboplatin and Paclitaxel in Patients With Chemotherapy-Naïve Select Stage IIIB or Stage IV Non-Small Cell Lung Cancer

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Related Information
Registry Information

Alternate Title

Erlotinib With or Without Carboplatin and Paclitaxel in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IITreatmentActive18 and overNCICALGB-30406
NCT00126581

Special Category: NCI Web site featured trial

Objectives

Primary

  1. Determine the progression-free survival of patients with chemotherapy-naïve select stage IIIB or stage IV non-small cell lung cancer treated with erlotinib with or without carboplatin and paclitaxel.

Secondary

  1. Determine the radiographic response rate in patients treated with these regimens.
  2. Correlate the frequency of epidermal growth factor receptor (EGFR) mutations and K-ras mutations with the response rate and time to progression in patients treated with these regimens.
  3. Determine the median and overall survival of patients treated with these regimens.

Entry Criteria

Disease Characteristics:

  • Histologically confirmed primary non-small cell lung cancer (NSCLC)
    • Adenocarcinoma histology, including any of the following histologic variants:
      • Pure or mixed bronchoalveolar cell carcinoma
      • Adenosquamous cell carcinoma
    • No NSCLC not otherwise specified


  • Pathology block or unstained slides from initial or subsequent diagnosis available
    • At least a core biopsy required
    • Fine needle aspirate alone is not sufficient


  • Meets 1 of the following stage criteria:
    • Select stage IIIB disease with cytologically documented malignant pleural or pericardial effusion
    • Stage IV disease


  • Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
    • The following are considered non-measurable disease:
      • Bone lesions
      • Leptomeningeal disease
      • Ascites
      • Pleural or pericardial effusion
      • Lymphangitis cutis/pulmonis
      • Abdominal masses not confirmed and followed by imaging techniques
      • Cystic lesions


  • Meets 1 of the following criteria for smoking history:
    • Non-smoker, defined as a person who smoked ≤ 100 cigarettes in their lifetime
    • Former light smoker, defined as a person who smoked ≤ 10 pack years AND quit smoking ≥ 1 year ago


  • No uncontrolled CNS metastases (i.e., any known CNS lesion that is radiographically unstable, symptomatic, and/or requires corticosteroids)


Prior/Concurrent Therapy:

Biologic therapy

  • No prior trastuzumab (Herceptin®) or cetuximab

Chemotherapy

  • No prior chemotherapy, including neoadjuvant or adjuvant chemotherapy
  • No other concurrent chemotherapy

Endocrine therapy

  • See Disease Characteristics
  • No concurrent hormonal therapy except for the following:
    • Hormones for non-disease-related conditions (e.g., insulin for diabetes)
    • Steroids for adrenal failure
    • Intermittent use of dexamethasone as an antiemetic or to prevent paclitaxel hypersensitivity reactions

Radiotherapy

  • At least 3 weeks since prior radiotherapy, including cranial irradiation
  • No concurrent radiotherapy, including palliative radiotherapy

Surgery

  • At least 3 weeks since prior major surgery
  • No prior significant surgical resection of the stomach or small bowel

Other

  • No prior erlotinib, gefitinib, or lapatinib
  • No other prior treatment targeting the HER family axis
  • More than 4 weeks since prior and no other concurrent investigational agents

Patient Characteristics:

Age

  • 18 and over

Performance status

  • ECOG 0-1

Life expectancy

  • Not specified

Hematopoietic

  • Granulocyte count ≥ 1,500/mm3
  • Platelet count ≥ 100,000/mm3
  • Hemoglobin ≥ 9.0 g/dL

Hepatic

  • AST ≤ 2.5 times upper limit of normal (ULN)
  • Total bilirubin ≤ ULN

Renal

  • Creatinine ≤ 1.5 mg/dL

Gastrointestinal

  • Able to swallow tablets intact or dissolved in water
  • No dysphagia
  • No active gastrointestinal disease or disorder that would alter gastrointestinal motility or absorption
  • No lack of integrity of the gastrointestinal tract

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

Expected Enrollment

180

A total of 180 patients (80 for arm I and 100 for arm II) will be accrued for this study within 1.5 years.

Outcomes

Primary Outcome(s)

Progression-free survival (PFS) rate at 18 weeks

Secondary Outcome(s)

Response rate
Median and overall survival rate
Correlation of response with presence or absence of epidermal growth factor receptor (EGFR) mutations
PFS in presence or absence of EGFR mutations
Correlation of response and PFS in presence or absence of K-ras mutations
Toxicity

Outline

This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive oral erlotinib once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.


  • Arm II: Patients receive erlotinib as in arm I. Patients also receive paclitaxel IV over 1-3 hours and carboplatin IV over 15-30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses of treatment, patients may continue to receive erlotinib alone as above.


After completion of study treatment, patients are followed at least every 3 months for 1 year and then every 6 months for up to 2 years.

Trial Contact Information

Trial Lead Organizations

Cancer and Leukemia Group B

Pasi Janne, MD, PhD, Protocol chair
Ph: 617-632-6076; 866-790-4500
Email: pjanne@partners.org
Vincent Miller, MD, Protocol co-chair
Ph: 212-639-7243; 800-525-2225
Email: millerv@mskcc.org

Trial Sites

U.S.A.
California
  La Jolla
 Rebecca and John Moores UCSD Cancer Center
 Clinical Trials Office - Rebecca and John Moores UCSD Cancer Center
Ph: 858-822-5354
 Email: cancercto@ucsd.edu
  San Diego
 Kaiser Permanente Medical Office -Vandever Medical Office
 Han Koh
Ph: 619-528-2596
Florida
  Fort Lauderdale
 Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
 Clinical Trials Office - Michael and Dianne Bienes Comprehensive Cancer Center
Ph: 954-776-3239
  Jupiter
 Ella Milbank Foshay Cancer Center at Jupiter Medical Center
 Clinical Trials Office - Ella Milbank Foshay Cancer Center
Ph: 561-745-5768
  Miami Beach
 CCOP - Mount Sinai Medical Center
 Rogerio Lilenbaum, MD
Ph: 305-535-3310
Georgia
  Savannah
 Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
 Clinical Trials Office - Curtis and Elizabeth Anderson Cancer Institute
Ph: 912-350-8568
Illinois
  Chicago
 University of Chicago Cancer Research Center
 Clinical Trials Office - University of Chicago Cancer Research Center
Ph: 773-834-7424
Indiana
  Elkhart
 Elkhart General Hospital
 Rafat Ansari, MD, FACP
Ph: 574-234-5123
  Kokomo
 Howard Community Hospital
 Rafat Ansari, MD, FACP
Ph: 574-234-5123
  La Porte
 Center for Cancer Therapy at LaPorte Hospital and Health Services
 Rafat Ansari, MD, FACP
Ph: 574-234-5123
  South Bend
 CCOP - Northern Indiana CR Consortium
 Rafat Ansari, MD, FACP
Ph: 574-234-5123
 Memorial Hospital of South Bend
 Clinical Trials Office - Memorial Hospital of South Bend
Ph: 800-284-7370
 Saint Joseph Regional Medical Center
 Rafat Ansari, MD, FACP
Ph: 574-234-5123
Iowa
  Iowa City
 Holden Comprehensive Cancer Center at University of Iowa
 Cancer Information Service
Ph: 800-237-1225
Maryland
  Baltimore
 Greenebaum Cancer Center at University of Maryland Medical Center
 Clinical Trials Office - Greenebaum Cancer Center at University of Maryladn Medical Center
Ph: 800-888-8823
Massachusetts
  Boston
 Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
 Pasi Janne, MD, PhD
Ph: 617-632-6076
 Massachusetts General Hospital
 Clinical Trials Office - Massachusetts General Hospital
Ph: 877-726-5130
Michigan
  St. Joseph
 Lakeland Regional Cancer Care Center - St. Joseph
 Rafat Ansari, MD, FACP
Ph: 574-234-5123
Missouri
  Columbia
 Ellis Fischel Cancer Center at University of Missouri - Columbia
 Clinical Trial Office - Ellis Fischel Cancer Center
Ph: 573-882-4894
  Saint Louis
 Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
 Ramaswamy Govindan, MD
Ph: 314-362-4819
Nebraska
  Grand Island
 Saint Francis Cancer Treatment Center at Saint Francis Memorial Health Center
 Margaret Kessinger, MD
Ph: 402-559-7511
  North Platte
 Callahan Cancer Center at Great Plains Regional Medical Center
 Clinical Trials Office - Callahan Cancer Center at Great Plains Regional Medical Center
Ph: 308-696-7864
  Omaha
 UNMC Eppley Cancer Center at the University of Nebraska Medical Center
 Clinical Trials Office - UNMC Eppley Cancer Center at the University of Nebraska Medical Center
Ph: 800-999-5465
Nevada
  Las Vegas
 CCOP - Nevada Cancer Research Foundation
 John Ellerton, MD, CM
Ph: 702-384-0013
 University Medical Center of Southern Nevada
 John Ellerton, MD, CM
Ph: 702-384-0013
New York
  East Syracuse
 CCOP - Hematology-Oncology Associates of Central New York
 Jeffrey Kirshner, MD
Ph: 315-472-7504
  New York
 Memorial Sloan-Kettering Cancer Center
 Vincent Miller, MD
Ph: 212-639-7243
  Syracuse
 SUNY Upstate Medical University Hospital
 Clinical Trials Office - SUNY Upstate Medical University Hospital
Ph: 315-464-5476
North Carolina
  Chapel Hill
 Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
 Clinical Trials Office - Lineberger Comprehensive Cancer Center
Ph: 877-668-0683; 919-966-4432
  Charlotte
 Presbyterian Cancer Center at Presbyterian Hospital
 Clinical Trials Office - Presbyterian Cancer Center at Presbyterian Hospital
Ph: 704-384-5369
  Durham
 Duke Comprehensive Cancer Center
 Clinical Trials Office - Duke Comprehensive Cancer Center
Ph: 888-275-3853
  Goldsboro
 Wayne Memorial Hospital, Incorporated
 James Atkins, MD
Ph: 919-580-0000
  Hendersonville
 Pardee Memorial Hospital
 James Radford, MD
Ph: 828-692-8045
  Kinston
 Kinston Medical Specialists
 Peter Watson, MD
Ph: 252-559-2200ext.201
Ohio
  Columbus
 Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
 Ohio State University Cancer Clinical Trial Matching Service
Ph: 866-627-7616
 Email: osu@emergingmed.com
Oklahoma
  Oklahoma City
 Cancer Care Associates - Mercy Campus
 Howard Ozer, MD, PhD
Ph: 405-271-4022
 Oklahoma University Cancer Institute
 Howard Ozer, MD, PhD
Ph: 405-271-4022
Rhode Island
  Pawtucket
 Memorial Hospital of Rhode Island
 Humera Khurshid
Ph: 401-729-2000
South Carolina
  Florence
 McLeod Regional Medical Center
 Clinical Trials Office - McLeod Regional Medical Center
Ph: 843-679-7256
  Greenville
 CCOP - Greenville
 Jeffrey Giguere, MD, FACP
Ph: 864-987-7000
Vermont
  Berlin
 Mountainview Medical
 Dennis Sanders
Ph: 802-223-6196
  Burlington
 Fletcher Allen Health Care - University Health Center Campus
 Clinical Trials Office - Fletcher Allen Health Care
Ph: 802-656-8990
Virginia
  Richmond
 Virginia Commonwealth University Massey Cancer Center
 Clinical Trials Office -Virginia Commonwealth University Massey Cancer Center
Ph: 804-628-1939

Related Information

Featured trial article

Registry Information
Official Title A Phase II Randomized Study of OSI-774 (ERLOTINIB) (NSC #718781; IND#63, 383) With or Without Carboplatin/Paclitaxel in Patients with Previously Untreated Adenocarcinoma of the Lung who Never Smoked or were Former Light Smokers
Trial Start Date 2005-08-18
Trial Completion Date 2008-02-04 (estimated)
Registered in ClinicalTrials.gov NCT00126581
Date Submitted to PDQ 2005-06-10
Information Last Verified 2009-06-27
NCI Grant/Contract Number CA31946

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.

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