Trial Comparing Cetuximab With Pemetrexed/Cetuximab Therapy for Non-Small Cell Lung Cancer

• Status: Terminated
• Trial end date: 2009-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Chicago
• Collaborator: Bristol-Myers Squibb
• Treatments: Cetuximab; Pemetrexed

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/=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.