Lung Cancer Clinical Trial

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

Summary

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.

View Full Description

Full 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.

View Eligibility Criteria

Eligibility Criteria

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 is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

242

Study ID:

NCT00085501

Recruitment Status:

Completed

Sponsor:

Southwest Oncology Group

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There are 142 Locations for this study

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

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

242

Study ID:

NCT00085501

Recruitment Status:

Completed

Sponsor:


Southwest Oncology Group

How clear is this clinincal trial information?

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