Pemetrexed Plus Cetuximab in Patients With Recurrent Non Small Cell Lung Cancer

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Both pemetrexed and cetuximab have single agent activity in NSCLC and non-overlapping toxicity profiles. While 2-drug combination therapy has proven superior to single agent therapy in the first-line setting of NSCLC, no such phase III trials have been reported in the second-line setting. Therefore, the purpose of this study is to determine the feasibility of combining these drugs, assessing the toxicity profile, determining the MTD and evaluating the activity of the combination in an expanded phase II setting. If the combination appears to have promising activity, further evaluation of this regimen may be warranted comparing it to single agent pemetrexed or cetuximab alone.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nasser Hanna, M.D.
• Collaborators: Bristol-Myers Squibb; Eli Lilly and Company; ImClone LLC; Walther Cancer Institute
• Treatments: Cetuximab; Pemetrexed

Criteria

Inclusion Criteria:

• Histologic or cytologic diagnosis of NSCLC

• Recurrent or metastatic disease that is not amenable to curative therapyMeasurable disease according to RECIST

• At least one prior platinum containing regimen for either locally advanced or metastatic disease

• Prior chemotherapy must be completed at least 21 days prior to being registered for protocol therapy and the subject must have recovered from the acute toxicity effects of the regimen

• Ability and willingness to interrupt aspirin or other nonsteroidal anti-inflammatory agents for a 5-day period

• Prior radiation therapy allowed to < 25% of the bone marrow

• Negative pregnancy test

Exclusion Criteria:

• No active infection that in the opinion of the investigator would compromise the subject's ability to tolerate therapy.

• No serious concomitant systemic disorders that would compromise the safety of the subject or compromise the subject's ability to complete the study, at the discretion of the investigator.

• No prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the subject has been disease-free for at least 2 years.

• No major thoracic or abdominal surgery within 30 days prior to being registered for protocol therapy.

• No current breastfeeding