Pemetrexed Plus Cetuximab in Patients With Recurrent Non Small Cell Lung Cancer - Full Text View

Sponsors and Collaborators:	Hoosier Oncology Group Eli Lilly and Company Bristol-Myers Squibb ImClone Systems Walther Cancer Institute
Information provided by:	Hoosier Oncology Group
ClinicalTrials.gov Identifier:	NCT00216203

Purpose

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

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Pemetrexed disodium Pemetrexed Cetuximab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by Hoosier Oncology Group:

Primary Outcome Measures:

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 [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
The primary objective of the phase II portion is to estimate the time to progression of this combination [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The secondary objectives of the phase II portion are to estimate the clinical benefit rate (CR + PR + SD lasting more than 90 days), median survival time and to further characterize the toxicity profile of this combination [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Enrollment:	25
Study Start Date:	May 2005
Study Completion Date:	May 2006

Arms	Assigned Interventions
1: Active Comparator 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

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

Hematopoietic:

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

Hepatic:

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

Renal:

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

Cardiovascular:

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

Pulmonary:

Not specified

Eligibility

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

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00216203

Locations

United States, Illinois
Medical & Surgical Specialists, LLC
Galesburg, Illinois, United States, 61401
United States, Indiana
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202
Cancer Care Center of Southern Indiana
Bloomington, Indiana, United States, 47403
Center for Cancer Care at Goshen Health System
Goshen, Indiana, United States, 46527
Elkhart Clinic
Elkhart, Indiana, United States, 46515
Fort Wayne Oncology & Hematology, Inc
Fort Wayne, Indiana, United States, 46815
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

Hoosier Oncology Group

Eli Lilly and Company

Bristol-Myers Squibb

ImClone Systems

Walther Cancer Institute

Investigators

Study Chair:

Nasser Hanna, M.D.

Hoosier Oncology Group, LLC

More Information

Hoosier Oncology Group Home Page This link exits the ClinicalTrials.gov site

Responsible Party:	Hoosier Oncology Group ( Nasser Hanna, M.D. )
Study ID Numbers:	HOG LUN04-79
Study First Received:	September 12, 2005
Last Updated:	April 2, 2008
ClinicalTrials.gov Identifier:	NCT00216203
Health Authority:	United States: Food and Drug Administration

Keywords provided by Hoosier Oncology Group:

Non-Small Cell Lung Cancer

Study placed in the following topic categories:

Folic Acid
Pemetrexed
Thoracic Neoplasms
Non-small cell lung cancer
Respiratory Tract Diseases
Lung Neoplasms

Lung Diseases
Cetuximab
Carcinoma, Non-Small-Cell Lung
Recurrence
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Antimetabolites
Respiratory Tract Neoplasms
Neoplasms
Antimetabolites, Antineoplastic
Neoplasms by Site
Neoplasms by Histologic Type

Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Folic Acid Antagonists
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009