S0342: Paclitaxel, Carboplatin, and Cetuximab in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer

Phase II Selection Design Trial Of Concurrent Chemotherapy + Cetuximab Vs. Chemotherapy Followed By Cetuximab In Advanced Non-Small Cell Lung Cancer (NSCLC)

RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining more than one chemotherapy drug with a monoclonal antibody may kill more tumor cells. It is not yet known whether cetuximab is more effective when given at the same time as chemotherapy or following chemotherapy.

PURPOSE: This randomized phase II trial is studying how well giving cetuximab at the same time as combination chemotherapy works compared to giving cetuximab after combination chemotherapy in treating patients with stage IIIB or stage IV non-small cell lung cancer.

Study Overview

• Status: Completed
• Conditions: Lung Cancer
• Intervention / Treatment: Drug: cetuximab; Drug: carboplatin; Drug: paclitaxel

Detailed Description

OBJECTIVES:

Primary

• Compare overall survival of patients with selected stage IIIB or stage IV non-small cell lung cancer treated with concurrent vs sequential paclitaxel, carboplatin, and cetuximab.

Secondary

• Compare response rates (confirmed and unconfirmed, complete and partial) in patients treated with these regimens.
• Compare the toxic effects of these regimens in these patients.
• Correlate epidermal growth factor receptor polymorphisms and downstream biomarkers with response to cetuximab in these patients.

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

• Arm I (concurrent cetuximab): Patients receive cetuximab IV over 1 hour (over 2 hours on day 1 of course 1 only) on days 1, 8, and 15 and paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 8. Treatment repeats every 21 days for a total of 4 courses (12 weeks) in the absence of disease progression or unacceptable toxicity. Beginning on week 13, patients receive single-agent cetuximab IV over 1 hour once weekly in the absence of disease progression or unacceptable toxicity.
• Arm II (sequential cetuximab): Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for a total of 4 courses (12 weeks) in the absence of disease progression or unacceptable toxicity. Beginning on week 13, patients receive single-agent cetuximab IV over 1 hour (over 2 hours on week 13 only) once weekly in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 1 year and then every 6 months for 2 years.

PROJECTED ACCRUAL: A total of 180 patients (90 per treatment arm) will be accrued for this study within 9 months.

• Study Type: Interventional
• Enrollment (Actual): 242
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alaska
    • Anchorage, Alaska, United States, 99508
      • Alaska Regional Hospital
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
  • California
    • Berkeley, California, United States, 94705
      • Alta Bates Comprehensive Cancer Center
    • Burlingame, California, United States, 94010
      • Peninsula Medical Center
    • Duarte, California, United States, 91010
      • City of Hope Comprehensive Cancer Center
    • Greenbrae, California, United States, 94904
      • Sutter Health Western Division Cancer Research Group
    • Greenbrae, California, United States, 94904
      • Marin Cancer Institute at Marin General Hospital
    • Hayward, California, United States, 94545
      • Saint Rose Hospital
    • Livermore, California, United States, 94550
      • Valley Memorial Hospital
    • Los Angeles, California, United States, 90033-0804
      • USC/Norris Comprehensive Cancer Center and Hospital
    • Oakland, California, United States, 94602
      • Highland General Hospital
    • Oakland, California, United States, 94609
      • CCOP - Bay Area Tumor Institute
    • Oakland, California, United States, 94609
      • Summit Medical Center
    • Palm Springs, California, United States, 92262
      • Comprehensive Cancer Center at Desert Regional Medical Center
    • Roseville, California, United States, 95661
      • Sutter Roseville Medical Center
    • Sacramento, California, United States, 95816
      • Sutter Cancer center
    • Sacramento, California, United States, 95819
      • Mercy General Hospital
    • Sacramento, California, United States, 95817
      • University of California Davis Cancer Center
    • San Francisco, California, United States, 94118
      • California Pacific Medical Center - California Campus
    • San Pablo, California, United States, 94806
      • J.C. Robinson, M.D. Regional Cancer Center
    • Sana Rosa, California, United States, 95405
      • CCOP - Santa Rosa Memorial Hospital
  • Colorado
    • Denver, Colorado, United States, 80220
      • Veterans Affairs Medical Center - Denver
    • Denver, Colorado, United States, 80204
      • St. Anthony Central Hospital
    • Denver, Colorado, United States, 80217-3364
      • University of Colorado Cancer Center at University of Colorado Health Sciences Center
    • Fort Collins, Colorado, United States, 80524
      • Poudre Valley Hospital
    • Montrose, Colorado, United States, 81401
      • Montrose Memorial Hospital Cancer Center
    • Westminster, Colorado, United States, 80030
      • St. Anthony North Hospital
    • Wheat Ridge, Colorado, United States, 80033
      • Exempla Lutheran Medical Center
  • Georgia
    • Atlanta, Georgia, United States, 30309
      • Piedmont Hospital
    • Atlanta, Georgia, United States, 30342
      • Saint Joseph's Hospital of Atlanta
    • Atlanta, Georgia, United States, 30342
      • CCOP - Atlanta Regional
    • Atlanta, Georgia, United States, 30342
      • Northside Hospital Cancer Center
    • Augusta, Georgia, United States, 30901
      • Augusta Oncology Associates
    • Austell, Georgia, United States, 30106
      • WellStar Cobb Hospital
    • Decatur, Georgia, United States, 30033
      • Charles B. Eberhart Cancer Center at DeKalb Medical Center
    • Gainesville, Georgia, United States, 30501
      • Northeast Georgia Medical Center
    • Lawrenceville, Georgia, United States, 30045
      • Gwinnett Medical Center
    • Marietta, Georgia, United States, 30060
      • Kennestone Cancer Center at Wellstar Kennestone Hospital
    • Riverdale, Georgia, United States, 30274
      • Southern Regional Medical Center
    • Savannah, Georgia, United States, 31403
      • Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
    • Valdosta, Georgia, United States, 31603
      • Pearlman Comprehensive Cancer Center at South Georgia Medical Center
  • Hawaii
    • Aiea, Hawaii, United States, 96701
      • Kapiolani Medical Center at Pali Momi
    • Honolula, Hawaii, United States, 96813
      • Cancer Research Center of Hawaii
    • Honolulu, Hawaii, United States, 96826
      • Kapiolani Medical Center for Women and Children
    • Honolulu, Hawaii, United States, 96813
      • OnCare Hawaii, Incorporated - Lusitana
    • Honolulu, Hawaii, United States, 96813
      • Queen's Cancer Institute at Queen's Medical Center
    • Honolulu, Hawaii, United States, 96813
      • Straub Clinic and Hospital, Incorporated
    • Honolulu, Hawaii, United States, 96817
      • OnCare Hawaii, Incorporated - Kuakini
    • Honolulu, Hawaii, United States, 96817
      • St. Francis Medical Center
  • Idaho
    • Boise, Idaho, United States, 83712
      • St. Luke's Mountain States Tumor Institute - Boise
  • Illinois
    • Alton, Illinois, United States, 62002
      • Saint Anthony's Hospital at Saint Anthony's Health Center
    • Maywood, Illinois, United States, 60153
      • Cardinal Bernardin Cancer Center at Loyola University Medical Center
    • Naperville, Illinois, United States, 60540
      • Hematology Oncology Consultants Ltd.
    • Naperville, Illinois, United States, 60566
      • Edward Hospital Cancer Center
  • Indiana
    • Beech Grove, Indiana, United States, 46107
      • St. Francis Hospital and Health Centers
  • Iowa
    • Davenport, Iowa, United States, 52804
      • Genesis Medical Center - West Campus
    • Davenport, Iowa, United States, 52803
      • Genesis Regional Cancer Center at Genesis Medical Center
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
    • Salina, Kansas, United States, 67401
      • Salina Regional Health Center
    • Wichita, Kansas, United States, 67214
      • Via Christi Cancer Center at Via Christi Regional Medical Center
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Tulane Cancer Center
    • Shreveport, Louisiana, United States, 71101
      • Cancer Treatment Center at Christus Schumpert St. Mary Place
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Cancer Research Center at Boston Medical Center
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Comprehensive Cancer Center
    • Ann Arbor, Michigan, United States, 48106-0995
      • St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital
    • Ann Arbor, Michigan, United States, 48100
      • CCOP - Michigan Cancer Research Consortium
    • Battle Creek, Michigan, United States, 49017
      • Cancer Care Center at Battle Creek Health System
    • Bay City, Michigan, United States, 48708
      • Bay Regional Medical Center
    • Big Rapids, Michigan, United States, 49307
      • Mecosta County General Hospital
    • Detroit, Michigan, United States, 48202
      • Josephine Ford Cancer Center at Henry Ford Health System
    • Flint, Michigan, United States, 48532
      • Genesys Hurley Cancer Institute
    • Grand Rapids, Michigan, United States, 49503
      • CCOP - Grand Rapids
    • Grand Rapids, Michigan, United States, 49503
      • Lacks Cancer Center at Saint Mary's Mercy Medical Center
    • Grand Rapids, Michigan, United States, 49503
      • Spectrum Health Cancer Care - Butterworth Campus
    • Grand Rapids, Michigan, United States, 49506
      • Metropolitan Hospital
    • Grand Rapids, Michigan, United States, 49506
      • Spectrum Health Hospital - Blodgett Campus
    • Holland, Michigan, United States, 49423
      • Holland Community Hospital
    • Mount Clemens, Michigan, United States, 48043
      • Mount Clemens General Hospital
    • Muskegon, Michigan, United States, 49443
      • Hackley Hospital
    • Petoskey, Michigan, United States, 49770
      • Northern Michigan Hospital
    • Pontiac, Michigan, United States, 48341-2985
      • St. Joseph Mercy Hospital
    • Saginaw, Michigan, United States, 48601
      • Seton Cancer Institute - Saginaw
    • Traverse City, Michigan, United States, 49684
      • Munson Medical Center
    • Warren, Michigan, United States, 48903
      • St. John Macomb Hospital
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • University of Mississippi Medical Center
    • Kessler AFB, Mississippi, United States, 39534-2519
      • Keesler Medical Center - Keesler Air Force Base
  • Missouri
    • Cape Girardeau, Missouri, United States, 63701
      • St. Francis Medical Center
    • Gape Girardeau, Missouri, United States, 63701
      • Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital
    • Joplin, Missouri, United States, 64804
      • Freeman Cancer Institute at Freeman Health System
    • Springfield, Missouri, United States, 65804
      • St. John's Regional Health Center
    • Springfield, Missouri, United States, 65807
      • Hulston Cancer Center at Cox Medical Center South
    • St. Louis, Missouri, United States, 63141
      • CCOP - St. Louis-Cape Girardeau
    • St. Louis, Missouri, United States, 63141
      • David C. Pratt Cancer Center at St. John's Mercy
  • Montana
    • Billings, Montana, United States, 59101
      • CCOP - Montana Cancer Consortium
    • Great Falls, Montana, United States, 59405
      • Great Falls Clinic
    • Great Falls, Montana, United States, 59405
      • Big Sky Oncology
    • Great Falls, Montana, United States, 59405
      • Sletten Regional Cancer Institute
  • New Jersey
    • Ridgewood, New Jersey, United States, 07450
      • Valley Hospital - Ridgewood
  • New York
    • Glens Falls, New York, United States, 12801
      • Adirondack Cancer Care
    • Rochester, New York, United States, 14642
      • James P. Wilmot Cancer Center at University of Rochester Medical Center
  • North Carolina
    • Charlotte, North Carolina, United States, 28203
      • Blumenthal Cancer Center at Carolinas Medical Center
    • Goldsboro, North Carolina, United States, 27534
      • Wayne Memorial Hospital, Incorporated
    • Hendersonville, North Carolina, United States, 28791
      • Pardee Memorial Hospital
    • Rutherfordton, North Carolina, United States, 28139
      • Rutherford Hospital
  • Ohio
    • Akron, Ohio, United States, 44307
      • McDowell Cancer Center at Akron General Medical Center
    • Cincinnati, Ohio, United States, 45220
      • Tri-Health Good Samaritan Hospital
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Taussig Cancer Center
    • Dayton, Ohio, United States, 45428
      • Veterans Affairs Medical Center - Dayton
    • Dayton, Ohio, United States, 45405
      • Grandview Hospital
    • Dayton, Ohio, United States, 45406
      • Good Samaritan Hospital
    • Dayton, Ohio, United States, 45409
      • David L. Rike Cancer Center at Miami Valley Hospital
    • Dayton, Ohio, United States, 45415
      • Samaritan North Cancer Care Center
    • Dayton, Ohio, United States, 45429
      • CCOP - Dayton
    • Independence, Ohio, United States, 44131
      • Community Oncology Group - Independence
    • Kettering, Ohio, United States, 45429
      • Charles F. Kettering Memorial Hospital
    • Mansfield, Ohio, United States, 44903
      • MedCentral - Mansfield Hospital
    • Middletown, Ohio, United States, 45044
      • Middletown Regional Hospital
    • Troy, Ohio, United States, 45373
      • UVMC Cancer Care Center at Upper Valley Medical Center
    • Wooster, Ohio, United States, 44691
      • Cleveland Clinic - Wooster
    • Wright-Patterson Afb, Ohio, United States, 45433-5529
      • United States Air Force Medical Center Wright-Patterson
    • Xenia, Ohio, United States, 45385
      • Ruth G. McMillan Cancer Center at Greene Memorial Hospital
  • Oregon
    • Bend, Oregon, United States, 97701
      • St. Charles Medical Center
    • Glesham, Oregon, United States, 97030
      • Legacy Mount Hood Medical Center
    • Milwaukie, Oregon, United States, 97222
      • Providence Milwaukie Hospital
    • Portland, Oregon, United States, 97225
      • CCOP - Columbia River Oncology Program
    • Portland, Oregon, United States, 97225
      • Providence St. Vincent Medical Center
    • Portland, Oregon, United States, 97210
      • Comprehensive Cancer Center at Legacy Good Samaritan Hospital & Medical Center
    • Portland, Oregon, United States, 97213
      • Providence Cancer Center at Providence Portland Medical Center
    • Portland, Oregon, United States, 97227
      • Institute of Oncology at Vilnius University
    • Salem, Oregon, United States, 97309
      • Salem Hospital Regional Cancer Center
    • Tualatin, Oregon, United States, 97062
      • Legacy Meridian Park Hospital
  • South Carolina
    • Anderson, South Carolina, United States, 29621
      • Rose Ramer Cancer Clinic at Anderson Area Medical Center
    • Charleston, South Carolina, United States, 29425
      • Hollings Cancer Center at Medical University of South Carolina
    • Florence, South Carolina, United States, 29506
      • McLeod Regional Medical Center
    • Greenville, South Carolina, United States, 29615
      • CCOP - Greenville
    • Greenville, South Carolina, United States, 29601
      • Bon Secours St. Francis Health System
    • Greenville, South Carolina, United States, 29605
      • Greenville Hospital System Cancer Center
    • Spartanburg, South Carolina, United States, 29303
      • Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
    • Spartanburg, South Carolina, United States, 29304
      • CCOP - Upstate Carolina
  • Tennessee
    • Knoxville, Tennessee, United States, 37916
      • Thompson Cancer Survival Center
  • Texas
    • Arlington, Texas, United States, 76012
      • Arlington Cancer Center - Arlington
    • Fort Sam Houston, Texas, United States, 78234
      • Brooke Army Medical Center
    • Lackland AFB, Texas, United States, 78236
      • Wilford Hall Medical Center
    • Lubbock, Texas, United States, 79415
      • UMC Southwest Cancer and Research Center
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • Huntsman Cancer Institute at University of Utah
  • Virginia
    • Danville, Virginia, United States, 24541
      • Danville Regional Medical Center
    • Martinsville, Virginia, United States, 24115
      • Memorial Hospital of Martinsville and Henry County
  • Washington
    • Bellingham, Washington, United States, 98225
      • St. Joseph Hospital Community Cancer Center
    • Bremerton, Washington, United States, 98310
      • Olympic Hematology and Oncology
    • Mt. Vernon, Washington, United States, 98273
      • Cancer Care Center at Skagit Valley Hospital
    • Seattle, Washington, United States, 98104
      • Harborview Medical Center
    • Seattle, Washington, United States, 98104
      • Fred Hutchinson Cancer Research Center
    • Seattle, Washington, United States, 98195
      • University Cancer Center at University of Washington Medical Center
    • Seattle, Washington, United States, 98104
      • Group Health Central Hospital
    • Seattle, Washington, United States, 98114
      • Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
    • Spokane, Washington, United States, 99202
      • Cancer Care Northwest - Spokane South
    • Spokane, Washington, United States, 99204
      • Providence Cancer Center at Sacred Heart Medical Center
    • Spokane, Washington, United States, 99207
      • Providence Cancer Center at Holy Family Hospital
    • Vancouver, Washington, United States, 98668
      • Southwest Washington Medical Center Cancer Center
    • Wenatchee, Washington, United States, 98801
      • Central Washington Hospital
    • Wenatchee, Washington, United States, 98801
      • Wenatchee Valley Clinic
    • Yakima, Washington, United States, 98902
      • North Star Lodge Cancer Center
    • Yakima, Washington, United States, 98902
      • Washington Hematology - Oncology Specialists

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) of one of the following stages:

  • Newly diagnosed selected stage IIIB disease (T4 lesion due to malignant pleural effusion, any N, M0)
  • Newly diagnosed stage IV disease (any T, any N, M1)
  • Recurrent stage IV disease after prior surgery or radiotherapy

• The following subtypes are eligible:

  • Adenocarcinoma
  • Squamous cell carcinoma
  • Large cell carcinoma
  • Unspecified

• Measurable disease by CT scan, MRI, x-ray, or physical exam

  • Pleural effusions, ascites, or laboratory parameters are not acceptable as the only evidence of disease
  • Not within prior radiotherapy field unless a new lesion is present
  • Not within area of prior surgical resection
• No known brain metastases by CT scan or MRI

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• Zubrod 0-1

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count ≥ 1,500/mm^3
• Platelet count ≥ 100,000/mm^3
• Hemoglobin ≥ 9 mg/dL

Hepatic

• Bilirubin ≤ 2 times upper limit of normal (ULN)
• SGOT or SGPT ≤ 2 times ULN
• Alkaline phosphatase ≤ 2 times ULN
• No known acute hepatitis

Renal

• Creatinine ≤ ULN
• Creatinine clearance ≥ 50 mL/min

Cardiovascular

• No significant cardiac disease
• No uncontrolled hypertension
• No unstable angina
• No congestive heart failure

Other

• No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer currently in complete remission
• No active or uncontrolled infection
• No sensory neuropathy ≥ grade 2
• No known human anti-mouse antibodies
• Not pregnant or nursing
• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No prior biologic therapy for NSCLC
• No prior chimeric or murine monoclonal antibody therapy
• No prior cetuximab

Chemotherapy

• No prior systemic chemotherapy for NSCLC

Endocrine therapy

• Not specified

Radiotherapy

• See Disease Characteristics
• At least 3 weeks since prior radiotherapy and recovered

Surgery

• See Disease Characteristics
• At least 2 weeks since prior thoracic or major surgery and recovered

Other

• No prior gefitinib or other investigational agents that target the epidermal growth factor receptor pathway

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 2	Drug: cetuximab; Arm 1: 400 mg/m2 (Initial dose), 2 hour IV infusion on Day 1, Week 1 only. 250 mg/m2 (Subsequent doses), 1 hour IV infusion, on Day 1 weekly starting at Week 2. Arm 2: 400 mg/m2 (Initial dose), 2 hour IV infusion on Week 13 ONLY 250 mg/m2 (Subsequent doses), 1 hour IV infusion, weekly starting at Week 14.; Drug: carboplatin; Arm 1: AUC=6 30 minute IV infusion immediately following paclitaxel on Day 1 q 21 days x 4 starting at Week 2 Arm 2: AUC=6 30 minute IV infusion immediately following paclitaxel on Day 1 q 21 days x 4 starting at Week 1; Drug: paclitaxel; Arm 1: 225 mg/m2 3 hour IV infusion 1 hour following cetuximab on Day 1, q 21 days x 4 Starting at Week 4. Arm 2: 225 mg/m2 3 hour IV infusion 1 hour following cetuximab on Day 1, q 21 days x 4 Starting at Week 1.
Active Comparator: 1	Drug: cetuximab; Arm 1: 400 mg/m2 (Initial dose), 2 hour IV infusion on Day 1, Week 1 only. 250 mg/m2 (Subsequent doses), 1 hour IV infusion, on Day 1 weekly starting at Week 2. Arm 2: 400 mg/m2 (Initial dose), 2 hour IV infusion on Week 13 ONLY 250 mg/m2 (Subsequent doses), 1 hour IV infusion, weekly starting at Week 14.; Drug: carboplatin; Arm 1: AUC=6 30 minute IV infusion immediately following paclitaxel on Day 1 q 21 days x 4 starting at Week 2 Arm 2: AUC=6 30 minute IV infusion immediately following paclitaxel on Day 1 q 21 days x 4 starting at Week 1; Drug: paclitaxel; Arm 1: 225 mg/m2 3 hour IV infusion 1 hour following cetuximab on Day 1, q 21 days x 4 Starting at Week 4. Arm 2: 225 mg/m2 3 hour IV infusion 1 hour following cetuximab on Day 1, q 21 days x 4 Starting at Week 1.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Select a regimen based on overall survival	To select a regimen based on overall survival via a Phase II selection design of chemotherapy in conjunction with cetuximab (concurrent vs. sequential) for Phase III testing against chemotherapy alone in Stage IIIB and Stage IV non-small cell lung cancer.	From date of registration until the date of progression or date of death from any cause, whichever came first, assessed up to 3 years
Response rate (confirmed and unconfirmed, complete and partial response)	To evaluate response rates (confirmed and unconfirmed, complete and partial) of patients with selected Stage IIIB and Stage IV NSCLC treated with paclitaxel and carboplatin with concurrent cetuximab or paclitaxel and carboplatin followed by cetuximab.	From date of registration until the date of progression or date of death from any cause, whichever came first, assessed up to 3 years
Toxicities	To evaluate the toxicities of the two treatment regimens in patients with selected Stage IIIB and Stage IV NSCLC.	From date of registration until the date of progression or date of death from any cause, whichever came first, assessed up to 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation of epidermal growth factor receptor polymorphisms and downstream biomarkers with response	To conduct exploratory molecular correlative studies of the EGFR-HER signaling pathways examining activated phosphoproteins, oncogenic mutations and rates of proliferation and apoptosis in patient tissues (see S9925 for details).	At prestudy
Evaluate EGFR polymorphisms	To evaluate EGFR polymorphisms as a potential correlate for response to cetuximab (see S9925 for details).	At prestudy and week 5

Collaborators and Investigators

• Sponsor: Southwest Oncology Group
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Karen Kelly, MD, University of Colorado, Denver; Principal Investigator: Roy S. Herbst, MD, PhD, M.D. Anderson Cancer Center; Principal Investigator: David R. Gandara, MD, University of California, Davis

Publications and helpful links

General Publications

• Franklin WA, Gandara DR, Kim ES, et al.: SWOG S0342 and S0536: expression of EGFR protein and markers of epithelial-mesenchymal transformation (EMT) in cetuximab/chemotherapy-treated non-small cell lung cancer (NSCLC). [Abstract] J Clin Oncol 27 (Suppl 15): A-11076, 2009.
• Mack PC, Holland WS, Redman M, et al.: KRAS mutation analysis in cetuximab-treated advanced stage non-small cell lung cancer (NSCLC): SWOG experience with S0342 and S0536. [Abstract] J Clin Oncol 27 (Suppl15): A-8022, 2009.
• Hirsch FR, Herbst RS, Olsen C, Chansky K, Crowley J, Kelly K, Franklin WA, Bunn PA Jr, Varella-Garcia M, Gandara DR. Increased EGFR gene copy number detected by fluorescent in situ hybridization predicts outcome in non-small-cell lung cancer patients treated with cetuximab and chemotherapy. J Clin Oncol. 2008 Jul 10;26(20):3351-7. doi: 10.1200/JCO.2007.14.0111.
• Herbst RS, Chansky K, Kelly K, et al.: A phase II randomized selection trial evaluating concurrent chemotherapy plus cetuximab or chemotherapy followed by cetuximab in patients with advanced non-small cell lung cancer (NSCLC): final report of SWOG 0342. [Abstract] J Clin Oncol 25 (Suppl 18): A-7545, 395s, 2007.
• Kelly K, Herbst RS, Crowley JJ, et al.: Concurrent chemotherapy plus cetuximab or chemotherapy followed by cetuximab in advanced non-small cell lung cancer (NSCLC): a randomized phase II selectional trial SWOG 0342. [Abstract] J Clin Oncol 24 (Suppl 18): A-7015, 367s, 2006.

Study record dates

Study Major Dates

• Study Start: July 1, 2004
• Primary Completion (Actual): August 1, 2007
• Study Completion (Actual): July 1, 2011

Study Registration Dates

• First Submitted: June 10, 2004
• First Submitted That Met QC Criteria: June 10, 2004
• First Posted (Estimate): June 11, 2004

Study Record Updates

• Last Update Posted (Estimate): November 1, 2012
• Last Update Submitted That Met QC Criteria: October 30, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Keywords: recurrent non-small cell lung cancer; stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer; squamous cell lung cancer; large cell lung cancer; adenocarcinoma of the lung
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Antineoplastic Agents, Immunological; Carboplatin; Paclitaxel; Cetuximab
• Other Study ID Numbers: CDR0000370806; U10CA032102 (U.S. NIH Grant/Contract); S0342 (Other Identifier: SWOG)