Status:
COMPLETED
Cetuximab, Paclitaxel, Carboplatin, and Radiation Therapy in Treating Patients With Unresectable Stage IIIA or Stage IIIB Non-Small Cell Lung Cancer
Lead Sponsor:
Radiation Therapy Oncology Group
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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, suc...
Detailed Description
OBJECTIVES: Primary * Determine the feasibility of cetuximab when administered concurrently with paclitaxel, carboplatin, and radiotherapy, in terms of safety and compliance, in patients with unrese...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
End Date :
November 1 2013
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00081302
Start Date
March 1 2004
End Date
November 1 2013
Last Update
November 17 2015
Active Locations (1)
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1
Arlington Cancer Center - Arlington
Arlington, Texas, United States, 76012