Phase 2
N=27
Cetuximab Plus Conformal Thoracic Radiotherapy in Patients (Pts) With Inoperable or Unresectable Locally Advanced Non-Small Cell Lung Cancer (LA - NSCLC)
Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00673738 ↗Enrolled (actual)
27
Serious AEs
74.1%
Results posted
Mar 2014
Primary outcome: Primary: Median Progression Free Survival (PFS) — 7.5 months
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Cetuximab (Drug); Conformal Thoracic Radiotherapy (CTRT) (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Median Progression Free Survival (PFS) |
7.5 | — |
| SECONDARY Median Overall Survival (OS) |
10.5 | — |
| SECONDARY Overall Response Rate (ORR) |
59.3; 0 | — |
Summary
This research is being done to find out if a treatment consisting of a combination of thoracic radiotherapy with cetuximab, given together, and followed by chemotherapy with docetaxel and cetuximab (also given together) will kill the cancer cells in the patient's body and shrink the size of their tumor without causing unacceptable side effects. This may allow patients to live longer or decrease the frequency and/or severity of the symptoms caused by the cancer without increasing the frequency and/or severity of the symptoms caused by the treatment.
Eligibility Criteria
Inclusion Criteria
- Histologically or cytologically confirmed inoperable or unresectable, LA-NSCLC (adenocarcinoma, squamous cell carcinoma or anaplastic large cell carcinoma or non-small cell otherwise not specified).
- Eligible Stages: Stages IIA through IIIA disease if it is felt that they are not candidates for possible resection, medically or otherwise. Stage IIIA (multi-station mediastinal lymph nodes) and stage IIIB disease without significant pleural effusion (metastases to contralateral mediastinal or supraclavicular lymph nodes) are also eligible.
- Age ≥ 70 OR Eastern Cooperative Oncology Group (ECOG) performance status (PS) = 2 at time of registration OR weight loss ≥ 5% in the preceding three months to the time of registration
- Must have measurable disease by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. When applicable, baseline measurements/evaluations must be obtained within 4 weeks prior to registration.
- Must have adequate bone marrow reserve as determined by the following laboratory values, obtained within 14 days prior to registration:
- White blood cell count (WBC) ≥ 4000/ul or absolute neutrophil count (ANC) ≥ 1000/ul
- Platelet count ≥ 100,000/ul
- Hemoglobin ≥ 8 gms/dl
- Adequate renal and liver function as determined by the following laboratory values, obtained within 14 days prior to registration:
- Serum creatinine ≤ 2.0 mg/dl or creatinine clearance ≥ 40 cc/min
- Bilirubin 3 years are allowed.
- Prior thoracic radiotherapy or epidermal growth factor receptor (EGFR) pathway targeting therapy. Prior systemic chemotherapy is allowed if received as therapy for an invasive malignancy, currently disease-free > 3 years
- Concomitant life threatening or uncontrolled serious medical illness such as cardiac disease (uncontrolled hypertension, arrhythmia, unstable angina, recent myocardial infarction, end stage congestive heart failure, cardiomyopathy with decreased ejection fraction), liver disease with significant hepatic insufficiency, kidney disease with significant renal insufficiency or organic brain syndrome.
Data sourced from ClinicalTrials.gov (NCT00673738). 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.