Trial Comparing Cetuximab With Pemetrexed/Cetuximab Therapy for Non-Small Cell Lung Cancer - Full Text View

Sponsors and Collaborators:	University of Chicago Bristol-Myers Squibb
Information provided by:	University of Chicago
ClinicalTrials.gov Identifier:	NCT00203931

Purpose

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.

Condition	Intervention	Phase
Non-Small Cell Lung Cancer	Drug: Cetuximab Drug: Cetuximab and Pemetrexed	Phase II

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Pemetrexed Pemetrexed disodium Cetuximab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized Phase II Trial Comparing Cetuximab With Concurrent Pemetrexed/Cetuximab Therapy for Non-Small Cell Lung Cancer Refractory to Primary Treatment

Further study details as provided by University of Chicago:

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 treatmen [ 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 ]

Estimated Enrollment:	80
Study Start Date:	March 2005
Estimated Study Completion Date:	July 2008
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A - Cetuximab: Experimental	Drug: Cetuximab Cetuximab every week by vein
B: Experimental	Drug: Cetuximab and Pemetrexed Cetuximab and Pemetrexed

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Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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.
Age>18
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

Exclusion Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00203931

Locations

United States, Illinois
The University of Chicago
Chicago, Illinois, United States, 60637

Sponsors and Collaborators

University of Chicago

Bristol-Myers Squibb

Investigators

Principal Investigator:

Everett Vokes, M.D.

University of Chicago

More Information

No publications provided

Responsible Party:	The University of Chicago ( Michael Maitland, MD )
Study ID Numbers:	13722A
Study First Received:	September 12, 2005
Last Updated:	June 2, 2008
ClinicalTrials.gov Identifier:	NCT00203931 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Chicago:

Non-small cell lung cancer

Study placed in the following topic categories:

Thoracic Neoplasms
Antimetabolites
Cetuximab
Folic Acid Antagonists
Carcinoma
Pemetrexed
Folic Acid

Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Non-small Cell Lung Cancer
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Antimetabolites
Thoracic Neoplasms
Respiratory Tract Neoplasms
Antimetabolites, Antineoplastic
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cetuximab
Enzyme Inhibitors
Folic Acid Antagonists
Pharmacologic Actions

Carcinoma
Pemetrexed
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 07, 2009