Trial Comparing Cetuximab With Pemetrexed/Cetuximab Therapy for Non-Small Cell Lung Cancer
This study has been terminated.
(Slow accrual and evidence from other studies showing benefit of early initiation of pemetrexed after first-line therapy)
Information provided by (Responsible Party):
University of Chicago
First received: September 12, 2005
Last updated: February 12, 2014
Last verified: February 2014
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
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:
- Progression-free Survival [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
Progression-free survival will be defined as the time from the start of treatment until progression (documented according to Response Evaluation Criteria in Solid Tumors [RECIST] criteria and defined as at least a 20% increase in the sum of the longest diameter of target lesions) or death from any cause, whichever comes first.
Secondary Outcome Measures:
- Progression-free Survival Based on Rash Development [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
Progression-free survival in this landmark analysis looking at the utility of early rash in predicting progression-free survival will be defined as the time from day 22 of study therapy until progression (documented according to Response Evaluation Criteria in Solid Tumors [RECIST] criteria and defined as at least a 20% increase in the sum of the longest diameter of target lesions) or death from any cause, whichever comes first. Patients last known to be alive and progression-free were censored at the date of the last scan without evidence of progression.
- Objective Response Rate [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]
Objective response (complete response [CR] + partial response [PR]) will be evaluated using RECIST criteria. CR is the disappearance of all target lesions. PR requires at least a 30% decrease in the sum of the longest diameter of target lesions.
- Overall Survival [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
Overall survival will be defined as the time from the start of treatment until death from any cause.
- Progression-free Survival Based on Serum Biomarker Status [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
Progression-free survival in this analysis looking at the association between a serum proteomic biomarker and progression-free survival will be defined as the time from the start of treatment until progression (documented according to Response Evaluation Criteria in Solid Tumors [RECIST] criteria and defined as at least a 20% increase in the sum of the longest diameter of target lesions) or death from any cause, whichever comes first.
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||November 2008 (Final data collection date for primary outcome measure)
Active Comparator: Cetuximab
Cetuximab initial dosage of 400 mg/m2 over 120 minutes, followed by weekly infusions at 250 mg/m2 over 60 minutes.
Other Name: ERBITUX
Experimental: Cetuximab and Pemetrexed
Cetuximab initial dosage of 400 mg/m2 over 120 minutes, followed by weekly infusions at 250 mg/m2 over 60 minutes. Starting on day 15 and then subsequently on day 1 of each 21 day cycle, Pemetrexed 500 mg/m2.
Other Name: ERBITUX
Other Name: ALIMTA
|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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
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.
||University of Chicago
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 12, 2005
|Results First Received:
||December 10, 2013
||February 12, 2014
||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 July 23, 2014
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists