Lung Cancer
Conditions
Keywords
stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer
Brief 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.
Detailed description
OBJECTIVES: Primary \* Determine the 11 month survival rate in older and/or poor performance status patients with stage IIIA or stage IIIB non-small cell lung cancer treated with cetuximab and radiotherapy. Secondary * Determine the tumor response rate, overall survival, and time to disease progression in patients treated with this regimen. * Determine the toxicity of this regimen in these patients. * Determine whether fear of death is less severe in the oldest of patients treated with this regimen. * Determine whether fear of death predicts survival of patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, 36, and 43. Beginning on day 8, patients receive concurrent radiotherapy once daily on days 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47. Treatment continues in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed within 1 week, at 1 and 4 months, and then every 3 months for up to 3 years. PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 20 months
Interventions
BIOLOGICALcetuximab
RADIATIONradiation therapy
Sponsors
National Cancer Institute (NCI)
Alliance for Clinical Trials in Oncology
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 11-month Survival Rate | From baseline to 11 months. | Eleven-month survival was chosen as the survival endpoint in this trial because it represents an improvement over the median survival that is observed with radiation alone. 11-month survival will be considered synonymous with success, unless specified otherwise. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. All evaluable patients will be followed from the time of protocol enrollment until death or a minimum of 11 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Survival Time | From baseline to up to 3 years | Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier. |
| Time to Disease Progression | From Baseline to up to 3 years | Time to disease progression is defined as the time from registration to documentation of disease progression. If a patient dies without a documentation of disease progression, the patient will be considered to have had tumor progression at the time of their death unless there is sufficient documented evidence to conclude no progression occurred prior to death. |
| Tumor Response (Complete and Partial) | Baseline, 1 month and 4 months after completion of treatment and then every 3 months until Progressive Disease (PD) or up to a maximum of 3 years from registration | A confirmed tumor response is defined to be a Complete Response (CR) or Partial Response (PR) noted as the objective status on 2 consecutive evaluations at least 3 months apart. All patients meeting the eligibility criteria who have signed a consent form and have begun treatment will be evaluable for response. |
Countries
United States
Participant flow
Recruitment details
This study enrolled a total of 58 patients. All patients received study treatment, and one patient was deemed ineligible during an North Central Cancer Treatment Group (NCCTG) audit. This analysis includes all 58 patients, with the exception of Overall Survival (OS), Time to Progression (TTP), and response which remove the ineligible patient.
Participants by arm
| Arm | Count |
|---|---|
| Cetuximab/Radiation Cetuximab (C225) and Radiation therapy | 58 |
| Total | 58 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Ineligible | 1 |
Baseline characteristics
| Characteristic | Cetuximab/Radiation |
|---|---|
| Age, Customized Median Age in years (Range) | 77 years |
| Region of Enrollment United States | 58 participants |
| Sex: Female, Male Female | 23 Participants |
| Sex: Female, Male Male | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 58 / 58 |
| serious Total, serious adverse events | 3 / 58 |
Outcome results
Primary
11-month Survival Rate
Eleven-month survival was chosen as the survival endpoint in this trial because it represents an improvement over the median survival that is observed with radiation alone. 11-month survival will be considered synonymous with success, unless specified otherwise. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. All evaluable patients will be followed from the time of protocol enrollment until death or a minimum of 11 months.
Time frame: From baseline to 11 months.
Population: This study enrolled a total of 58 patients. All patients received study treatment, and one patient was deemed ineligible during an NCCTG audit. This analysis includes all 57 patients. Forty of 57 patients (70%) reached the 11-month survival primary point.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cetuximab/Radiation | 11-month Survival Rate | 70 percentage of participants |
Secondary
Survival Time
Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.
Time frame: From baseline to up to 3 years
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cetuximab/Radiation | Survival Time | 15.1 months |
Secondary
Time to Disease Progression
Time to disease progression is defined as the time from registration to documentation of disease progression. If a patient dies without a documentation of disease progression, the patient will be considered to have had tumor progression at the time of their death unless there is sufficient documented evidence to conclude no progression occurred prior to death.
Time frame: From Baseline to up to 3 years
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cetuximab/Radiation | Time to Disease Progression | 7.2 months |
Secondary
Tumor Response (Complete and Partial)
A confirmed tumor response is defined to be a Complete Response (CR) or Partial Response (PR) noted as the objective status on 2 consecutive evaluations at least 3 months apart. All patients meeting the eligibility criteria who have signed a consent form and have begun treatment will be evaluable for response.
Time frame: Baseline, 1 month and 4 months after completion of treatment and then every 3 months until Progressive Disease (PD) or up to a maximum of 3 years from registration
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cetuximab/Radiation | Tumor Response (Complete and Partial) | Number of patients with Partial Response (PR) | 15 participants |
| Cetuximab/Radiation | Tumor Response (Complete and Partial) | Number of patients with Complete Response (CR) | 0 participants |