Cetuximab Plus Conformal Thoracic Radiotherapy in Patients (Pts) With Inoperable or Unresectable Locally Advanced Non-Small Cell Lung Cancer (LA - NSCLC)
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Cetuximab; Conformal Thoracic Radiotherapy (CTRT)
Intervention description: Cetuximab dose: based on patient's actual weight. Loading phase dose of cetuximab is 400 mg/m2 IV administered over 120 minutes, on day 1 followed by; Concurrent phase, weekly infusion dose at 250 mg/m2 IV over 60 minutes, on days 8, 15, 22, 29, 36, 43, 50.
Radiation will be accompanied by weekly Cetuximab. Weekly Cetuximab will start on 1st day of radiation (Day 8). So, total number of cetuximab administrations will vary from 7 to 8. Patients will have every other week complete blood counts (CBCs), differentials, and blood urea nitrogen (BUN) plus creatinine and Mg. If patient's ANC drops below 1,000 and/or the platelet count below 75,000 during CTRT, the corresponding, weekly dose of cetuximab will be omitted.; Radiation will be accompanied by weekly Cetuximab. Weekly Cetuximab will start on 1st day of radiation (Day 8). So, total number of cetuximab administrations will vary from 7 to 8. Patients will have every other week CBCs, differentials, and BUN plus creatinine and Mg. If patient's ANC drops below 1,000 and/or the platelet count below 75,000 during CTRT, the corresponding, weekly dose of cetuximab will be omitted.
Radiation therapy will begin on day 8 (with window of ± 3 days). Adequate hematologic profile (ANC >1,000 and platelets >75,000) required. Patient may be delayed for a max. of 2 weeks. If > 2 week delay occurs, patient will come off study.
Intervention MeSH terms: Docetaxel; Cetuximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Lung; Thoracic; Immunotherapy; Radiotherapy; LA - NSCLC; Non-Small Cell Lung Cancer

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 < 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 Criteria:

          -  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.