Status:
COMPLETED
S0342: Paclitaxel, Carboplatin, and Cetuximab in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Lead Sponsor:
SWOG Cancer Research Network
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
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 cetuxima...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
242 Patients enrolled
Trial Details
Trial ID
NCT00085501
Start Date
July 1 2004
End Date
July 1 2011
Last Update
November 1 2012
Active Locations (163)
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1
Alaska Regional Hospital
Anchorage, Alaska, United States, 99508
2
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
3
Alta Bates Comprehensive Cancer Center
Berkeley, California, United States, 94705
4
Peninsula Medical Center
Burlingame, California, United States, 94010