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

• Status: Completed
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Southwest Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Cetuximab; Paclitaxel

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