Phase 2
N=36
Pemetrexed Plus Cetuximab in Patients With Recurrent Non Small Cell Lung Cancer
Non-Small Cell Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00216203 ↗Enrolled (actual)
36
Serious AEs
30.6%
Results posted
Jun 2016
Primary outcome: Primary: Maximum Tolerated Dose (MTD) of Pemetrexed in Combination With Cetuximab — 750 mg/m^2 every 21 days
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Pemetrexed (Drug); Cetuximab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Nasser Hanna, M.D.
- Primary completion
- Dec 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Tolerated Dose (MTD) of Pemetrexed in Combination With Cetuximab |
750 | — |
| PRIMARY Time To Progression (TTP) |
14.6 | — |
| SECONDARY Median Survival Time |
42.0 | — |
| SECONDARY Toxicity and Safety Profile |
58.3; 16.7; 57; 23.8; 33.3; 16.7 | — |
| SECONDARY Clinical Benefit Rate |
— | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00216203). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.