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.
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.
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
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There are 142 Locations for this study
Anchorage Alaska, 99508, United States
Little Rock Arkansas, 72205, United States
Berkeley California, 94705, United States
Burlingame California, 94010, United States
Duarte California, 91010, United States
Greenbrae California, 94904, United States
Greenbrae California, 94904, United States
Hayward California, 94545, United States
Livermore California, 94550, United States
Los Angeles California, 90033, United States
Oakland California, 94602, United States
Oakland California, 94609, United States
Oakland California, 94609, United States
Palm Springs California, 92262, United States
Roseville California, 95661, United States
Sacramento California, 95816, United States
Sacramento California, 95817, United States
Sacramento California, 95819, United States
San Francisco California, 94118, United States
San Pablo California, 94806, United States
Sana Rosa California, 95405, United States
Denver Colorado, 80204, United States
Denver Colorado, 80217, United States
Denver Colorado, 80220, United States
Fort Collins Colorado, 80524, United States
Montrose Colorado, 81401, United States
Westminster Colorado, 80030, United States
Wheat Ridge Colorado, 80033, United States
Atlanta Georgia, 30309, United States
Atlanta Georgia, 30342, United States
Atlanta Georgia, 30342, United States
Atlanta Georgia, 30342, United States
Augusta Georgia, 30901, United States
Austell Georgia, 30106, United States
Decatur Georgia, 30033, United States
Gainesville Georgia, 30501, United States
Lawrenceville Georgia, 30045, United States
Marietta Georgia, 30060, United States
Riverdale Georgia, 30274, United States
Savannah Georgia, 31403, United States
Valdosta Georgia, 31603, United States
Aiea Hawaii, 96701, United States
Honolula Hawaii, 96813, United States
Honolulu Hawaii, 96813, United States
Honolulu Hawaii, 96813, United States
Honolulu Hawaii, 96813, United States
Honolulu Hawaii, 96817, United States
Honolulu Hawaii, 96817, United States
Honolulu Hawaii, 96826, United States
Boise Idaho, 83712, United States
Alton Illinois, 62002, United States
Maywood Illinois, 60153, United States
Naperville Illinois, 60540, United States
Naperville Illinois, 60566, United States
Beech Grove Indiana, 46107, United States
Davenport Iowa, 52803, United States
Davenport Iowa, 52804, United States
Kansas City Kansas, 66160, United States
Salina Kansas, 67401, United States
Wichita Kansas, 67214, United States
New Orleans Louisiana, 70112, United States
Shreveport Louisiana, 71101, United States
Boston Massachusetts, 02118, United States
Ann Arbor Michigan, 48100, United States
Ann Arbor Michigan, 48106, United States
Ann Arbor Michigan, 48109, United States
Battle Creek Michigan, 49017, United States
Bay City Michigan, 48708, United States
Big Rapids Michigan, 49307, United States
Detroit Michigan, 48202, United States
Flint Michigan, 48532, United States
Grand Rapids Michigan, 49503, United States
Grand Rapids Michigan, 49503, United States
Grand Rapids Michigan, 49503, United States
Grand Rapids Michigan, 49506, United States
Grand Rapids Michigan, 49506, United States
Holland Michigan, 49423, United States
Mount Clemens Michigan, 48043, United States
Muskegon Michigan, 49443, United States
Petoskey Michigan, 49770, United States
Pontiac Michigan, 48341, United States
Saginaw Michigan, 48601, United States
Traverse City Michigan, 49684, United States
Warren Michigan, 48903, United States
Jackson Mississippi, 39216, United States
Kessler AFB Mississippi, 39534, United States
Cape Girardeau Missouri, 63701, United States
Gape Girardeau Missouri, 63701, United States
Joplin Missouri, 64804, United States
Springfield Missouri, 65804, United States
Springfield Missouri, 65807, United States
St. Louis Missouri, 63141, United States
St. Louis Missouri, 63141, United States
Billings Montana, 59101, United States
Great Falls Montana, 59405, United States
Great Falls Montana, 59405, United States
Great Falls Montana, 59405, United States
Ridgewood New Jersey, 07450, United States
Glens Falls New York, 12801, United States
Rochester New York, 14642, United States
Charlotte North Carolina, 28203, United States
Goldsboro North Carolina, 27534, United States
Hendersonville North Carolina, 28791, United States
Rutherfordton North Carolina, 28139, United States
Akron Ohio, 44307, United States
Cincinnati Ohio, 45220, United States
Cleveland Ohio, 44195, United States
Dayton Ohio, 45405, United States
Dayton Ohio, 45406, United States
Dayton Ohio, 45409, United States
Dayton Ohio, 45415, United States
Dayton Ohio, 45428, United States
Dayton Ohio, 45429, United States
Independence Ohio, 44131, United States
Kettering Ohio, 45429, United States
Mansfield Ohio, 44903, United States
Middletown Ohio, 45044, United States
Troy Ohio, 45373, United States
Wooster Ohio, 44691, United States
Wright-Patterson Afb Ohio, 45433, United States
Xenia Ohio, 45385, United States
Bend Oregon, 97701, United States
Glesham Oregon, 97030, United States
Milwaukie Oregon, 97222, United States
Portland Oregon, 97210, United States
Portland Oregon, 97213, United States
Portland Oregon, 97225, United States
Portland Oregon, 97225, United States
Portland Oregon, 97227, United States
Salem Oregon, 97309, United States
Tualatin Oregon, 97062, United States
Anderson South Carolina, 29621, United States
Charleston South Carolina, 29425, United States
Florence South Carolina, 29506, United States
Greenville South Carolina, 29601, United States
Greenville South Carolina, 29605, United States
Greenville South Carolina, 29615, United States
Spartanburg South Carolina, 29303, United States
Spartanburg South Carolina, 29304, United States
Knoxville Tennessee, 37916, United States
Arlington Texas, 76012, United States
Fort Sam Houston Texas, 78234, United States
Lackland AFB Texas, 78236, United States
Lubbock Texas, 79415, United States
Salt Lake City Utah, 84112, United States
Danville Virginia, 24541, United States
Martinsville Virginia, 24115, United States
Bellingham Washington, 98225, United States
Bremerton Washington, 98310, United States
Mt. Vernon Washington, 98273, United States
Seattle Washington, 98104, United States
Seattle Washington, 98104, United States
Seattle Washington, 98104, United States
Seattle Washington, 98114, United States
Seattle Washington, 98195, United States
Spokane Washington, 99202, United States
Spokane Washington, 99204, United States
Spokane Washington, 99207, United States
Vancouver Washington, 98668, United States
Wenatchee Washington, 98801, United States
Wenatchee Washington, 98801, United States
Yakima Washington, 98902, United States
Yakima Washington, 98902, United States
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