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Pemetrexed Plus Cetuximab in Patients With Recurrent Non Small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT00216203
Recruitment Status : Completed
First Posted : September 22, 2005
Results First Posted : June 2, 2016
Last Update Posted : September 29, 2016
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer Drug: Pemetrexed Drug: Cetuximab Phase 1 Phase 2

Detailed Description:

OUTLINE: This is a multi-center study.

Week 1 (day 1):

  • Cetuximab 400mg/m2

Week 2 (Cycle 1, Day 1):

  • Cetuximab 250mg/m2 plus premetrexed at the assigned dose level.

Patients will be treated with cetuximab on day 1, 8, 15 of each 21 day cycle.

Patients will be treated with pemetrexed on day 1 of each 21 day cycle for a maximum of 6 cycles.

Acceptable toxicity and SD, PR or CR: treat up to 6 cycles then continue cetuximab weekly until PD or excess toxicity

Performance status: ECOG 0-2

Life expectancy: At least 12 weeks


  • ANC > 1,500/mm3
  • Platelets > 100,000/mm3


  • Bilirubin less than or equal to the upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) < 1.5 X ULN. AST may be < 5 X ULN for patients with liver metastases
  • Alkaline phosphatase < 5 X ULN


  • Calculated creatinine clearance > 45 mL/min (by Cockcroft-Gault)


  • No significant history of uncontrolled cardiac disease (i.e., uncontrolled hypertension, unstable angina, and congestive heart failure)


  • Not specified

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I-IIa Dose-Ranging Study of Pemetrexed (Alimta) Plus Cetuximab (Erbitux) in Patients With Recurrent Non-Small Cell Lung Cancer (NSCLC): Hoosier Oncology Group LUN04-79
Study Start Date : May 2005
Primary Completion Date : December 2008
Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Investigational Treatment
Pemetrexed + cetuximab for patients with recurrent non-small cell lung cancer.
Drug: Pemetrexed
Pemetrexed at the assigned dose, day 1 of each 21 day cycle for a maximum of 6 cycles
Drug: Cetuximab

Cetuximab 400 mg/m2, week 1, day 1

Cetuximab 250 mg/m2, day 1, 8, 15 of each 21 day cycle

Outcome Measures

Primary Outcome Measures :
  1. Maximum Tolerated Dose (MTD) of Pemetrexed in Combination With Cetuximab [ Time Frame: 12 months ]
    The primary objective of the phase I portion of this study is to define the maximum tolerated dose (MTD) of the combination of pemetrexed and cetuximab

  2. Time To Progression (TTP) [ Time Frame: 24 Months ]
    The primary objective of the phase II portion is to estimate the time to progression of this combination, evaluated per RECIST criteria where PD= at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions

Secondary Outcome Measures :
  1. Median Survival Time [ Time Frame: 24 Months ]
  2. Toxicity and Safety Profile [ Time Frame: 12 months ]
  3. Clinical Benefit Rate [ Time Frame: 12 months ]
    Clinical Benefit Rate (CR + PR + SD lasting more than 90 days)

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00216203

United States, Illinois
Medical & Surgical Specialists, LLC
Galesburg, Illinois, United States, 61401
United States, Indiana
Cancer Care Center of Southern Indiana
Bloomington, Indiana, United States, 47403
Elkhart Clinic
Elkhart, Indiana, United States, 46515
Fort Wayne Oncology & Hematology, Inc
Fort Wayne, Indiana, United States, 46815
Center for Cancer Care at Goshen Health System
Goshen, Indiana, United States, 46527
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202
Medical Consultants, P.C.
Muncie, Indiana, United States, 47303
Northern Indiana Cancer Research Consortium
South Bend, Indiana, United States, 46601
United States, Maryland
Greenebaum Cancer Center
Baltimore, Maryland, United States, 21201
United States, Ohio
Oncology Hematology Care, Inc.
Cincinnati, Ohio, United States, 45242
United States, Texas
Texas Oncology Cancer Center
Austin, Texas, United States, 78731
Sponsors and Collaborators
Nasser Hanna, M.D.
Eli Lilly and Company
Bristol-Myers Squibb
ImClone LLC
Walther Cancer Institute
Study Chair: Nasser Hanna, M.D. Hoosier Oncology Group, LLC
More Information

Additional Information:
Responsible Party: Nasser Hanna, M.D., Sponsor-Investigator, Hoosier Cancer Research Network
ClinicalTrials.gov Identifier: NCT00216203     History of Changes
Other Study ID Numbers: HOG LUN04-79
First Posted: September 22, 2005    Key Record Dates
Results First Posted: June 2, 2016
Last Update Posted: September 29, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Nasser Hanna, M.D., Hoosier Cancer Research Network:
Non-Small Cell Lung Cancer

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors