Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Active 18 and over Pharmaceutical / Industry CP02-0452 NCT00095199

Trial Description

Summary

This trial is a multicenter, open-label, randomized, phase III study in patients with recurrent or progressive Non-Small Cell Lung Cancer (NSCLC) after failure of an initial platinum-based chemotherapy. Patients will be randomized to one of the following 4 treatment arms: Cetuximab plus Docetaxel, Cetuximab plus Pemetrexed, Docetaxel alone, or Pemetrexed alone.

Eligibility Criteria

Inclusion Criteria:

To be eligible for the study, patients must fulfill all of the following criteria:

1. Provided signed written informed consent.Target population

2. Pathologic confirmation of metastatic, unresectable, or locally-advanced NSCLC.

3. Disease progression during or following one prior platinum-based chemotherapy regimen for advanced disease (stage IIIB or IV). One additional prior regimen is allowed for neoadjuvant, adjuvant, or neoadjuvant plus adjuvant therapy.

4. Bidimensionally measurable disease, with at least one lesion with both perpendicular diameters ≥1.5 cm.

5. Karnofsky performance status score of 60 to 100 at study entry.

6. The patient has tumor tissue available for immunohistochemical determination of EGFR expression.

7. Adequate recovery from recent surgery, chemotherapy, and radiation therapy. At least 4 weeks must have elapsed from major surgery, prior chemotherapy, prior treatment with an investigational agent, or prior radiation therapy (palliative radiation therapy is allowed).

8. Accessible for treatment and follow-up. Patients enrolled in this trial must be treated at the participating center. Age and Gender

9. Men and women, aged ≥18 years. Women of childbearing potential (WOCBP) and fertile men with partners of childbearing potential must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 4 weeks after the study in such a manner that the risk of pregnancy is minimized.WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not postmenopausal (defined as amenorrhea ≥12 consecutive months; or women on hormone replacement therapy [HRT] with documented serum follicle stimulating hormone [FSH] level >35 mIU/mL). Even women who are using oral, implanted, or injectable contraceptive hormones or mechanical products, such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides), to prevent pregnancy, are practicing abstinence, or whose partner is sterile (eg, vasectomy), should be considered to be of childbearing potential.WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of beta human chorionic gonadotropin (βHCG), or in accordance with local regulations, whichever is more sensitive) within 72 hours prior to the start of study medication or in accordance with local regulations, whichever is of shorter duration.

Exclusion Criteria:

Any of the following criteria will make the patient ineligible to participate in this study:

1. WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 4 weeks after the study.

2. Women who are pregnant or breastfeeding.

3. Women with a positive pregnancy test on enrollment or prior to study therapy administration.

4. Sexually active fertile men not using effective birth control if their partners are women of child-bearing potential.

Medical History and Concurrent Diseases

5. Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.

6. A serious uncontrolled medical disorder that would impair the ability of the patient to receive protocol therapy.

7. Symptomatic or uncontrolled metastases in the brain. Patients receiving a glucocorticoid for brain metastases will be excluded, but those receiving anticonvulsants will be eligible.

8. Uncontrolled pleural effusion or ascites.

9. Peripheral neuropathy greater than grade 2, as assessed by the NCI-CTCAE, Version 3.0.

10. Any concurrent malignancy other than basal cell skin cancer, or carcinoma in situ of the cervix. Patients with a previous malignancy, but without evidence of disease for ≥3 years will be allowed to enter the trial.

11. More than one prior chemotherapy regimen for advanced disease.Physical and Laboratory Test Findings

12. Inadequate hematologic function defined by an absolute neutrophil count (ANC) <1,500/mm3, a platelet count <100,000/mm3, and a hemoglobin level <9 g/dL. Red blood cell transfusions are not permitted within 7 days of receiving cetuximab, docetaxel, or pemetrexed.

13. Inadequate hepatic function, defined by a total bilirubin level >1.5 times the upper limit of normal (ULN), aspartate transaminase (AST) and ALT levels >2.5 times the ULN (≥5 times the ULN if known liver metastases), and an alkaline phosphatase level >5.0 times the ULN.

14. Inadequate renal function defined by a serum creatinine level >1.5 times the ULN.

15. Prior treatment with cetuximab, or any other epidermal growth factor receptor inhibitors, including tyrosine kinase inhibitors, such as gefitinib or erlotinib. Patients must not have received prior chimerized or murine monoclonal antibody therapy. Prior treatment with other monoclonal antibodies targeting receptors other than the EGFR is permitted >30 days prior to randomization.

16. Prior treatment with docetaxel or pemetrexed therapy.

17. Inability or unwillingness to take folic acid or vitamin B12 supplementation.

18. Inability or unwillingness to interrupt nonsteroidal anti-inflammatory drugs (NSAIDs) for a 5-day period (8-day period for long-acting agents such as piroxicam). Aspirin will be permitted during the study.

19. Patients (including prisoners) who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (eg, infectious disease) illness.

20. Employees of the investigator or study center with direct involvement in this study or other studies under the direction of the investigator or study center, as well as family members of the employees.

21. Prior treatment with an experimental drug or medical device within 30 days of randomization.

Trial Contact Information

Trial Lead Organizations/Sponsors

ImClone Systems, Incorporated

Edward Kim, MD

Principal Investigator

Sarah Cappello, MPH		Ph: 908 927-8395
		Email: sarah.cappello@imclone.com

U.S.A.
Alabama
	Birmingham
	Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
		Francisco Robert, MD	Principal Investigator
	Montgomery
	Montgomery Cancer Center
		Stephen Davidson	Principal Investigator
Arizona
	Phoenix
	Arizona Hematology & Oncology Associates
		Michael S Roberts, MD	Principal Investigator
	Tucson
	Arizona Clinical Research Center, Incorporated
		Donald Brooks, MD	Principal Investigator
	Arizona Onc Assoc DBA Hema Onc Physicans and Extenders
		Richard K Rosenberg, MD	Principal Investigator
Arkansas
	Jonesboro
	Clopton Clinic, PA
		Marc Monte, MD	Principal Investigator
	Little Rock
	Little Rock Hematology Oncology Associates, PA - Little Rock
		Kamal Patel, MD	Principal Investigator
California
	Beverly Hills
	Tower Cancer Research Foundation
		Barry E. Rosenbloom	Principal Investigator
	Grass Valley
	Grass Valley Hematology Oncology
		David Campbell, MD	Principal Investigator
	Greenbrae
	California Cancer Care, Incorporated - Greenbrae
		Peter D. Eisenberg	Principal Investigator
	Orange
	Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
		S.H. Ignatius Ou, MD, PhD	Principal Investigator
	San Diego / La Jolla
	Rebecca and John Moores UCSD Cancer Center
		Lyudmila Bazhenova, MD	Principal Investigator
Colorado
	Denver
	Rocky Mountain Cancer Centers - Denver Rose
		Allen L. Cohn	Principal Investigator
Connecticut
	Greenwich
	Bendheim Cancer Center at Greenwich Hospital
		Dickerman Hollister Jr., MD	Principal Investigator
	Stamford
	Hematology Oncology, PC at Bennett Cancer Center
		Paul L Weinstein, MD	Principal Investigator
	Trumbull
	Oncology Associates of Bridgeport, PC - Trumbull
		Robert Folman, MD	Principal Investigator
Florida
	Fort Lauderdale
	Broward General Medical Center Cancer Center
		Israel Wiznitzer, MD	Principal Investigator
	Gainesville
	Gainesville Hematology Oncology Associates
		Lucio Gordan,, MD	Principal Investigator
	Gainsville
	Gainesville Hematology Oncology Associates
		Loucio Gordon, MD	Principal Investigator
	New Port Richey
	Florida Cancer Institute - New Port Richey
		Gerald J. Robbins, MD	Principal Investigator
	Ocala
	Ocala Oncology Center
		Craig H Reynolds, MD	Principal Investigator
		Craig H. Reynolds, MD	Principal Investigator
	Ocoee
	Cancer Centers of Florida - Ocoee
		Barry S. Berman	Principal Investigator
Illinois
	Centralia
	Southern Illinois Hematology/Oncology
		James E Hays, MD	Principal Investigator
	Chicago
	Rush Cancer Institute at Rush University Medical Center
		Philip Bonomi, M.D.
		Philip Bonomi, M.d.	Principal Investigator
	Niles
	Cancer Care and Hematology Specialists of Chicagoland - Niles
		Leonard M. Klein	Principal Investigator
Indiana
	Indianapolis
	Central Indiana Cancer Centers - South
		David M Loesch, MD	Principal Investigator
	Lafayette
	Clarian Arnett Cancer Care
		Mohammed M Khan, MD
		Mohammed M Khan, MD	Principal Investigator
Louisiana
	Metairie
	Jayne S. Gurtler, MD APMC
		Jayne G Gurtler, MD	Principal Investigator
Maryland
	Frederick
	Frederick Memorial Hospital Regional Cancer Therapy Center
		Elhamy Eskander, MD	Principal Investigator
Michigan
	Ann Arbor
	St Joseph Mercy Hospital
		Phillip J Stella, MD	Principal Investigator
	Grand Rapids
	Cancer and Hematology Centers of Western Michigan, PC - Grand Rapids
		Michael Zakem, DO
		Michael Howard Zakem	Principal Investigator
	Lansing
	Breslin Cancer Center at Ingham Regional Medical Center
		Barbara A Conley, MD
		Barbara A Conley, MD	Principal Investigator
Minnesota
	Minneapolis
	Minnesota Oncology Hematology, PA - Minneapolis
		Patrick J Flynn, MD	Principal Investigator
	St. Louis Park
	Park Nicollet Cancer Center
		Martin W. Lee, MD	Principal Investigator
Missouri
	Kansas City
	Kansas City Cancer Centers - South
		Marcus A. Neubauer	Principal Investigator
	St. Louis
	Hematology Oncology Consultants, Incorporated
		Mark Woodson	Principal Investigator
Montana
	Billings
	Hematology-Oncology Centers of the Northern Rockies - Billings
		Patrick Cobb, MD	Principal Investigator
Nevada
	Las Vegas
	Comprehensive Cancer Center of Nevada
		Matthew D Galsky, MD
		Matthew D Galsky, MD	Principal Investigator
New Hampshire
	Hooksett
	New Hampshire Oncology - Hematology, PA - Hooksett
		Douglas J Weckstein, MD	Principal Investigator
	Lebanon
	Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
		James R. Rigas	Principal Investigator
New Jersey
	Cherry Hill
	Center for Cancer and Hematologic Disease - Cherry Hill
		Stephen E Zrada, MD	Principal Investigator
	Morristown
	Hematology-Oncology Associates of Northern New Jersey, PA at Carol G. Simon Cancer Center
		Steven W Papish, MD	Principal Investigator
	Summit
	Overlook Hospital
		Michael B. Wax, MD	Principal Investigator
New Mexico
	Santa Fe
	New Mexico Cancer Care Associates
		Timothy Lopez, MD	Principal Investigator
New York
	Albany
	New York Oncology Hematology, PC at Albany Regional Cancer Care
		Lawrence E. Garbo	Principal Investigator
	New York
	St. Luke's-Roosevelt Hospital Center - Roosevelt Division
		Peter Kozuch, MD	Principal Investigator
	Rochester
	Interlakes Oncology/Hematology PC
		Alexander J Solky, MD	Principal Investigator
	Schenectady
	New York Oncology Hematology, PC at Ellis Hospital
		Thomas L Goodman, MD	Principal Investigator
North Carolina
	Cary
	Cancer Centers of North Carolina - Cary
		William R. Berry	Principal Investigator
	Concord
	NorthEast Oncology Associates - Concord
		Gary H. Schwartz, M.D.
		Gary H. Schwartz	Principal Investigator
Ohio
	Kettering
	Dayton Oncology and Hematology, PA - Kettering
		Robert N. Raju	Principal Investigator
Oklahoma
	Tulsa
	Cancer Care Associates - Saint Francis Campus
		Mark Olsen	Principal Investigator
Oregon
	Eugene
	Willamette Valley Cancer Center - Eugene
		Glenn S Buchanan, MD	Principal Investigator
	Portland
	Center for Health and Healing
		Christopher Ryan, MD	Principal Investigator
	Northwest Cancer Specialists - St. Vincent Office
		David A. Smith	Principal Investigator
	Oregon Health and Science University Cancer Institute
		Michael Heinrich, MD	Principal Investigator
		Rachel Sanborn, MD	Principal Investigator
Pennsylvania
	Bethlehem
	Oncology Hematology of Lehigh Valley, PC - Bethlehem
		Neil Belman, DO	Principal Investigator
	Kingston
	Medical Oncology Associates of Wyoming Valley, PC
		Bruce H Saidman, MD	Principal Investigator
	Philadelphia
	Fox Chase Cancer Center - Philadelphia
		Hossein Borghaei	Principal Investigator
South Carolina
	Charleston
	Charleston Cancer Center
		Charles S Holladay, MD	Principal Investigator
		Charles D Graham, MD	Principal Investigator
	Seneca
	Cancer Centers of the Carolinas - Spartanburg
		John D. Hunter, MD	Principal Investigator
Tennessee
	Memphis
	University of Tennessee Cancer Institute - Memphis
		Thomas Ratliff, MD	Principal Investigator
	West Clinic - East Memphis
		Lee S. Schwartzberg	Principal Investigator
Texas
	Abilene
	Texas Oncology, PA at Texas Cancer Center - South
		Anton M Melnyk, Jr, MD	Principal Investigator
	Arlington
	Arlington Cancer Center - Arlington
		Karel Dicke, MD	Principal Investigator
	Texas Oncology, PA at Texas Cancer Center - Arlington South
		Sanjay Awasthi, MD	Principal Investigator
	Bedford
	Texas Oncology, PA at Harris Center HEB
		Thomas C Anderson, MD	Principal Investigator
	Dallas
	Medical City Dallas Hospital
		Barry C. Mirtsching	Principal Investigator
	Texas Oncology, PA at Charles A. Sammons Cancer Center
		Kartik Konduri, MD
		Kartik Konduri, MD	Principal Investigator
	Texas Oncology, PA at Presbyterian Hospital Dallas
		Kristi J McIntyre, MD	Principal Investigator
	Texas Oncology, PA at Texas Cancer Center Medical City Dallas
		Michael A Savin, MD	Principal Investigator
	Houston
	Dan L. Duncan Cancer Center at Baylor College of Medicine
		Martha Mims, MD	Principal Investigator
	M. D. Anderson Cancer Center at University of Texas
		Edward Kim, MD	Principal Investigator
	San Antonio
	Cancer Care Centers of South Texas - Medical Center
		Gregory J Guzley, MD	Principal Investigator
	Sherman
	Texas Oncology, PA at Texas Cancer Center - Sherman
		Tammy E. Roque, MD	Principal Investigator
	Sugarland
	Texas Oncology, PA at Texas Oncology Cancer Center Sugar Land
		Caesar K Tin-U, MD
		Caesar K Tin-U,, MD	Principal Investigator
	Tyler
	Tyler Cancer Center
		Donald A. Richards	Principal Investigator
	Waco
	Texas Oncology, PA Cancer Care and Research Center
		Robert L Anderson, MD	Principal Investigator
Utah
	Salt Lake City
	Utah Cancer Specialists at UCS Cancer Center
		W. Graydon Harker, MD	Principal Investigator
Vermont
	Colchester
	Vermont Center for Cancer Medicine and Blood Disorders, Incorporated
		Christian Thomas, MD	Principal Investigator
Virginia
	Norfolk
	Virginia Oncology Associates - Lake Wright
		Paul R. Conkling	Principal Investigator
	Richmond
	Veterans Affairs Medical Center - Richmond
		Geoffrey Krystal, MD	Principal Investigator
	Salem
	Gyn-Oncology of Southwest Virgina
		Paul D. Richards	Principal Investigator
Washington
	Burien
	Highline Medical Oncology
		Robert E. Randolph, MD	Principal Investigator
	Edmonds
	Puget Sound Cancer Centers - Edmonds
		Richard A McGee, MD	Principal Investigator
	Seattle
	Puget Sound Cancer Centers - Seattle
		David E Dong, MD	Principal Investigator
	Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
		Gary E. Goodman, MD	Principal Investigator
Canada
Alberta
	Calgary
	Tom Baker Cancer Centre - Calgary
		Donald Morris, Dr.	Principal Investigator
British Columbia
	Vancouver
	British Columbia Cancer Agency - Vancouver Cancer Centre
		Nevin Murray, M.D.	Ph: (604) 877-6000
			Email: nmurray@bccancer.bc.ca
		Nevin Murray, M.D.	Principal Investigator
Ontario
	Ottawa
	Ottawa Hospital Regional Cancer Centre - General Campus
		Garth Nicholas, M.D.
		Garth Nicholas, M.D.	Principal Investigator
	Toronto
	Edmond Odette Cancer Centre at Sunnybrook
		Sunil Verma, MD	Principal Investigator
Quebec
	Montreal
	Hopital Notre-Dame du CHUM
		Jean-Pierre Ayoub, MD	Principal Investigator
	St-Jerome
	St-Jerome Medical Research Inc.
		Ghislain Cournoyer, Dr	Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00095199
Information obtained from ClinicalTrials.gov on October 06, 2008