Trial Comparing Cetuximab With Pemetrexed/Cetuximab Therapy for Non-Small Cell Lung Cancer
This study has been completed.
Information provided by (Responsible Party):
Michael Maitland, University of Chicago
First received: September 12, 2005
Last updated: October 1, 2012
Last verified: October 2012
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.
Non-small Cell Lung Cancer
Drug: Cetuximab and Pemetrexed
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Randomized Phase II Trial Comparing Cetuximab With Concurrent Pemetrexed/Cetuximab Therapy for Non-Small Cell Lung Cancer Refractory to Primary Treatment
Primary Outcome Measures:
- To determine in patients with NSCLC refractory to previous chemotherapy whether concomitant treatment with cetuximab and pemetrexed improves progression-free survival compared with cetuximab monotherapy. [ Time Frame: 8 weeks, 11 weeks, 14 weeks, 20 weeks, every 6-8 weeks thereafter ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To evaluate prospectively the utility of early rash in predicting outcome (progression-free survival time) to second-line NSCLC treatment. [ Time Frame: Prior to each cycle ] [ Designated as safety issue: No ]
- To compare objective response rates between combined cetuximab/pemetrexed therapy and cetuximab alone [ Time Frame: Every Cycle - Days 8 and 15 ] [ Designated as safety issue: No ]
- To compare overall survival in patients treated with combined cetuximab/pemetrexed vs. sequential therapy with cetuximab followed by pemetrexed. [ Time Frame: Study days 34-40 and continue every 21 days ] [ Designated as safety issue: No ]
- To identify a serum polypeptide signature predicting tumor response to cetuximab-containing therapy. [ Time Frame: Samples collected at enrollment & prior to 3rd dose of cetuxiimab therapy. ] [ Designated as safety issue: No ]
- To produce a material collection which may confirm an mRNA expression array signature categorizing activity of EGFR inhibitor therapy [ Time Frame: Skin Biopsies at enrollment & after 2 weeks of cetuximab therapy. ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||November 2008 (Final data collection date for primary outcome measure)
Active Comparator: Arm A
Cetuximab every week by vein
Other Name: ERBITUX
Experimental: Arm B
Cetuximab and Pemetrexed
Drug: Cetuximab and Pemetrexed
Cetuximab and Pemetrexed
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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 </=1.5 x ULN; ALT/AST ,/= 2.5 x ULN; Albumin >/=2.5 g/dL
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00203931
|The University of Chicago
|Chicago, Illinois, United States, 60637 |
University of Chicago
||Michael Maitland, M.D.
||University of Chicago
No publications provided by University of Chicago
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Maitland ML, Levine MR, Lacouture ME, Wroblewski KE, Chung CH, Gordon IO, Szeto L, Ratko G, Soltani K, Kozloff MF, Hoffman PC, Salgia R, Carbone DP, Karrison TG, Vokes EE. Evaluation of a novel rash scale and a serum proteomic predictor in a randomized phase II trial of sequential or concurrent cetuximab and pemetrexed in previously treated non-small cell lung cancer. BMC Cancer. 2014 Jan 4;14:5. doi: 10.1186/1471-2407-14-5.
||Michael Maitland, Assistant Professor of Medicine, University of Chicago
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 12, 2005
||October 1, 2012
||United States: Institutional Review Board
Keywords provided by University of Chicago:
Non-small cell lung cancer
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 06, 2014
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists