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

Completed · Phase 1/Phase 2

Conditions studied: Non-Small Cell Lung Cancer

In brief

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.

Key facts

Study ID

NCT00216203

Run by

Nasser Hanna, M.D.

People needed

36

Starts

2005-05-01

Expected to finish

2008-12-01

Last updated by the study team

2016-09-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Medical & Surgical Specialists, LLC — Galesburg, Illinois, United States
• Cancer Care Center of Southern Indiana — Bloomington, Indiana, United States
• Elkhart Clinic — Elkhart, Indiana, United States
• Fort Wayne Oncology & Hematology, Inc — Fort Wayne, Indiana, United States
• Center for Cancer Care at Goshen Health System — Goshen, Indiana, United States
• Indiana University Cancer Center — Indianapolis, Indiana, United States
• Medical Consultants, P.C. — Muncie, Indiana, United States
• Northern Indiana Cancer Research Consortium — South Bend, Indiana, United States
• Greenebaum Cancer Center — Baltimore, Maryland, United States
• Oncology Hematology Care, Inc. — Cincinnati, Ohio, United States
• Texas Oncology Cancer Center — Austin, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.