Status:
COMPLETED
Cetuximab Plus Conformal Thoracic Radiotherapy in Patients (Pts) With Inoperable or Unresectable Locally Advanced Non-Small Cell Lung Cancer (LA - NSCLC)
Lead Sponsor:
H. Lee Moffitt Cancer Center and Research Institute
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 (a...
Detailed Description
Patients will be asked to spend about six months in this study. There will be 4 different phases in this study as follows: (1) Loading Phase: This is the first week (week 1) of the study, when patient...
Eligibility Criteria
Inclusion
- 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 \< 2.0 mg/dl
- serum glutamic oxaloacetic transaminase (SGOT) ≤ 2.5 times the upper limit of normal(ULN)
- Written, informed consent must be obtained prior to registration
- Women of childbearing potential (WOCBP) must use an accepted, effective method of contraception during the course of the study, in a manner such that risk of failure is minimized. Sexually active males enrolled should understand the risks to any sexual partner of childbearing potential; must also practice an effective method of contraception. WOCBP must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy; have a negative pregnancy test within 7 days prior to first receiving investigational product; be instructed to contact the Investigator immediately if they suspect they might be pregnant at any time during study participation. Investigator must immediately notify Bristol-Myers Squibb (BMS) in the event of a confirmed pregnancy in a patient participating in the study. If the pregnancy test is positive, the patient must not receive investigational product and must not be enrolled in the study.
Exclusion
- Must not have small cell carcinoma as part of the histological specimen
- Evidence of distant metastasis.
- History of a prior or concomitant malignancy in the past 3 years except for surgically cured basal cell carcinoma of the skin or carcinoma in situ of the cervix. Invasive malignancies, properly treated and currently disease-free \> 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.
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00673738
Start Date
April 1 2008
End Date
August 1 2015
Last Update
October 8 2015
Active Locations (1)
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1
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612