Phase 2
N=58
Cetuximab and Radiation Therapy in Treating Patients With Stage III Non-Small Cell Lung Cancer
Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00124618 ↗Enrolled (actual)
58
Serious AEs
5.2%
Results posted
Mar 2015
Primary outcome: Primary: 11-month Survival Rate — 70 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- cetuximab (Biological); radiation therapy (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Alliance for Clinical Trials in Oncology
- Primary completion
- Feb 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 11-month Survival Rate |
70 | — |
| SECONDARY Survival Time |
15.1 | — |
| SECONDARY Time to Disease Progression |
7.2 | — |
| SECONDARY Tumor Response (Complete and Partial) |
15; 0 | — |
Summary
RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Cetuximab may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving cetuximab together with radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving cetuximab together with radiation therapy works in treating patients with stage III non-small cell lung cancer.
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
- Stage IIIA or IIIB disease
- Must be a candidate for curative radiotherapy
- Not a candidate for other concurrent chemotherapy and radiotherapy
- No surgical treatment available
- No pleural effusion suspected or proven to be malignant
- No stage IV disease by bone scan or positron emission tomography scan, CT scan or MRI of the brain, and CT scan of the chest within the past 30 days
PATIENT CHARACTERISTICS:
Age * 18 and over
Performance status
- Eastern Cooperative Oncology Group (ECOG) 0-2 (age ≥ 65 years)
- ECOG 2 (age 18 to 64 years)
Life expectancy
- At least 12 weeks
Hematopoietic
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 9 g/dL
Hepatic
- Bilirubin ≤ 2 times upper limit of normal (ULN)
- AST ≤ 3 times ULN
Renal
- Creatinine ≤ 1.5 times ULN
Pulmonary
- FEV\_1 ≥ 1 L
- No idiopathic pulmonary fibrosis
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Magnesium normal
- No uncontrolled infection
- No other severe underlying disease that would preclude study entry
- No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or noninvasive carcinoma
- No major psychiatric illness that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- See Disease Characteristics
- No prior chemotherapy for NSCLC
Endocrine therapy
- Not specified
Radiotherapy
- No prior therapeutic radiotherapy to the chest
- No concurrent intensity modulated radiotherapy
Other
- No prior epidermal growth factor receptor inhibitors
Data sourced from ClinicalTrials.gov (NCT00124618). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.