Cetuximab, Paclitaxel, Carboplatin, and Radiation Therapy in Treating Patients With Unresectable Stage IIIA or Stage IIIB Non-Small Cell Lung Cancer

• Status: Completed
• Trial end date: 2013-11-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. 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. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving cetuximab together with combination chemotherapy and radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving cetuximab together with paclitaxel, carboplatin, and radiation therapy works in treating patients with unresectable stage IIIA or stage IIIB non-small cell lung cancer.

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

Details

• Lead Sponsor: Radiation Therapy 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 1 of the following subtypes:

• Squamous cell carcinoma

• Adenocarcinoma (including bronchoalveolar cell)

• Large cell anaplastic carcinoma (including giant and clear cell carcinomas)

• Poorly differentiated/not otherwise specified NSCLC

• Stage IIIA (T1-2, N2, M0 or T3, N1-2, M0) or IIIB (T4, any N, M0 or any T, N2-3, M0)

• If the largest mediastinal node is < 2.0 cm in diameter and this is the basis for stage III disease, then at least 1 of the nodes must be cytologically or histologically positive

• Unresectable disease

• No totally resected tumors

• Tumors adjacent to a vertebral body allowed provided all gross disease can be encompassed in the radiation boost field and the boost volume is limited to < 50% of the ipsilateral lung volume

• Measurable disease

• Transudate, cytologically negative, non-bloody pleural effusions allowed provided the tumor can be encompassed within a reasonable field of radiotherapy

• Pleural effusions seen on a chest CT scan are allowed provided they are not visible on a chest x-ray and are too small to tap

• No asymptomatic or symptomatic brain metastases

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 g/dL (transfusion independent)

Hepatic

• Bilirubin ≤ 1.5 mg/dL

• SGOT (serum glutamic oxaloacetic transaminase) or SGPT (serum glutamate pyruvate transaminase) ≤ 3 times upper limit of normal (ULN)

• Alkaline phosphatase ≤ 2.5 times ULN

Renal

• Creatinine ≤ 2.0 mg/dL

Cardiovascular

• No significant history of cardiac disease

• No uncontrolled hypertension

• No unstable angina

• No uncompensated congestive heart failure

• No myocardial infarction within the past year

• No cardiac ventricular arrhythmias requiring medication

• LVEF (left ventricular ejection fraction) normal by MUGA (multi-gated acquisition) scan or echocardiogram

Pulmonary

• No history of interstitial pneumonitis

• No history of severe chronic obstructive pulmonary disease requiring 3 or more hospitalizations within the past year

• FEV_1 ≥ 1,200 cc

• No active pulmonary infection unresponsive to conventional antibiotics

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for 4 weeks after study therapy

• Glucose ≤ 2 times ULN

• No more than 5% weight loss within the past 3 months

• No known allergy to murine proteins or Cremophor EL

• No neuropathy grade 2 or greater

• No other malignancy within the past 2 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or other in situ cancers

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No prior drugs that target the epidermal growth factor receptor pathway

• No prior chimerized monoclonal antibody therapy

• No other concurrent immunotherapy

• No concurrent colony-stimulating factors (i.e., filgrastim [G-CSF] and sargramostim [GM-CSF])

• Concurrent epoetin alfa allowed

Chemotherapy

• No prior systemic chemotherapy

• No other concurrent chemotherapy

Endocrine therapy

• No concurrent hormonal therapy except hormones for non-disease-related conditions (e.g., insulin for diabetes) or steroids for acute symptom management, adrenal failure, septic shock, or as antiemetics

Radiotherapy

• No prior thoracic or neck radiotherapy

• No concurrent intensity-modulated radiotherapy

Surgery

• Recovered from prior exploratory thoracotomy

• No prior surgical resection of the present cancer

Other

• More than 30 days since prior participation in another clinical trial

• No concurrent participation in another clinical trial

• No other concurrent anticancer therapy

• No amifostine during or for 3 months after study radiotherapy