Trial Comparing Cetuximab With Pemetrexed/Cetuximab Therapy for Non-Small Cell Lung Cancer
Condition: Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Cetuximab; Pemetrexed
Intervention MeSH terms: Pemetrexed; Cetuximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 55.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Non-small cell lung cancer

Summary:

      The purpose of the study is to determine in patients with Non Small Cell Lung Cancer
      refractory to previous chemotherapy whether concomitant treatment with cetuximab and
      pemetrexed improves progression-free survival compared with cetuximab monotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of locally advanced or metastatic (Stage III or IV at entry) non-small cell
             lung cancer (NSCLC) that is not amenable to curative therapy.

          -  ECOG performance status 0-2

          -  Patients must have been previously treated with one platinum-containing or
             taxane-containing chemotherapy regimen for locally advanced or metastatic disease.
             Patients are also eligible if they have received one platinum-based chemotherapy
             regimen as neoadjuvant or adjuvant chemotherapy, but must have received an additional
             chemotherapy regimen upon recurrence.

          -  No more than two prior systemic anti-cancer therapies will be allowed.

          -  Prior radiation therapy is allowed to <25% of the bone marrow. Prior radiation to the
             whole pelvis is not allowed, Prior radiotherapy must be completed at least 2 weeks
             before study enrollment, and the patient must have recovered from the acute toxic
             effects of the treatment prior to study enrollment.

          -  Patients must have signed an approved informed consent.

          -  Male and female patients with reproductive potential must use an approved
             contraceptive method if appropriate (eg, intrauterine device, birth control pills, or
             barrier device) during and for 3 months after the study. Female patients must either
             not be of child bearing potential or have a negative pregnancy test within 7 days of
             treatment. Patients are considered not of child bearing potential if they are
             surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or
             bilateral oophorectomy) or they are postmenopausal.

          -  Age>18

          -  Measurable disease in accord with RECIST criteria

          -  Bone marrow Function: absolute neutrophil count (ANC)>/=1,500/ul, platelets
             >/=l00,000, hemoglobin> 9g/dL

          -  Renal function: creatinine clearance (calculated by Cockcroft and Gault method) >/=
             45mL/min

          -  Hepatic function: bilirubin </=1.5 x ULN; ALT/AST ,/= 2.5 x ULN; Albumin >/=2.5 g/dL

        Exclusion Criteria:

          -  Prior treatment with pemetrexed

          -  Prior therapy that targets the EGF pathway.

          -  Active or uncontrolled infection.

          -  Significant history of uncontrolled cardiac disease; i.e., uncontrolled hypertension,
             unstable angina, and congestive heart failure.

          -  Pleural or pericardial effusions that cannot be completely evacuated prior to
             pemetrexed therapy.

          -  Acute hepatitis or known HIV.

          -  Prior severe infusion reaction to a monoclonal antibody.

          -  Any concurrent chemotherapy not indicated in the study protocol or any other
             investigational agent(s).

          -  Pregnancy or Breast-feeding.

          -  Second primary malignancy that is clinically detectable at the time of consideration
             for study enrollment.

          -  Inability to interrupt aspirin, or other nonsteroidal anti-inflammatory agents for a
             5-day period.

          -  Inability or unwillingness to take folic acid or vitamin B12 supplementation.