Status:
COMPLETED
Pemetrexed Plus Cetuximab in Patients With Recurrent Non Small Cell Lung Cancer
Lead Sponsor:
Nasser Hanna, M.D.
Collaborating Sponsors:
Eli Lilly and Company
Bristol-Myers Squibb
Conditions:
Non-Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 ...
Detailed Description
OUTLINE: This is a multi-center study. Week 1 (day 1): * Cetuximab 400mg/m2 Week 2 (Cycle 1, Day 1): * Cetuximab 250mg/m2 plus premetrexed at the assigned dose level. Patients will be treated wit...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00216203
Start Date
May 1 2005
End Date
December 1 2008
Last Update
September 29 2016
Active Locations (11)
Enter a location and click search to find clinical trials sorted by distance.
1
Medical & Surgical Specialists, LLC
Galesburg, Illinois, United States, 61401
2
Cancer Care Center of Southern Indiana
Bloomington, Indiana, United States, 47403
3
Elkhart Clinic
Elkhart, Indiana, United States, 46515
4
Fort Wayne Oncology & Hematology, Inc
Fort Wayne, Indiana, United States, 46815