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)
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT00203931
First received: September 12, 2005
Last updated: February 12, 2014
Last verified: February 2014
  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: Pemetrexed
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Phase II Trial Comparing Cetuximab With Concurrent Pemetrexed/Cetuximab Therapy for Non-Small Cell Lung Cancer Refractory to Primary Treatment

Resource links provided by NLM:


Further study details as provided by University of Chicago:

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.


Enrollment: 55
Study Start Date: March 2005
Study Completion Date: November 2009
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cetuximab
Cetuximab initial dosage of 400 mg/m2 over 120 minutes, followed by weekly infusions at 250 mg/m2 over 60 minutes.
Drug: Cetuximab
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.
Drug: Cetuximab
Other Name: ERBITUX
Drug: Pemetrexed
Other Name: ALIMTA

  Show Detailed Description

  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
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

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: Michael Maitland, M.D. University of Chicago
  More Information

No publications provided by University of Chicago

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00203931     History of Changes
Other Study ID Numbers: 13722A
Study First Received: September 12, 2005
Results First Received: December 10, 2013
Last Updated: February 12, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Chicago:
Non-small cell lung cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Pemetrexed
Cetuximab
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Folic Acid Antagonists

ClinicalTrials.gov processed this record on August 19, 2014