A Phase I and Randomized Phase II Trial of Gemcitabine + Erlotinib (NSC-718781) + IMC-A12 (NSC-742460) vs. Gemcitabine + Erlotinib as First-Line Treatment in Patients With Metastatic Pancreatic Cancer
PRIMARY OBJECTIVES:
I. To assess the appropriate dose of IMC-A12 (cixutumumab) to use in combination with
gemcitabine (gemcitabine hydrochloride) and erlotinib (erlotinib hydrochloride). (Phase I)
II. To assess progression-free survival in patients with metastatic pancreatic cancer
treated with IMC-A12 plus gemcitabine and erlotinib compared to those treated with
gemcitabine plus erlotinib alone. (Phase II) III. To assess overall survival in each of the
two treatment arms in this group of patients. (Phase II) IV. To assess the total response
probability (confirmed and unconfirmed, complete and partial responses) in each of the two
treatment arms in the subset of this group of patients with measurable disease. (Phase II)
V. To assess the qualitative and quantitative toxicities in each of the two treatment arms
in this group of patients. (Phase II)
OUTLINE: This is a multicenter, phase I, dose-escalation study of cixutumumab followed by a
randomized, phase II study.
Patients are initially enrolled into the phase I portion of the study to determine the
recommended phase II dose (RPTD) of cixutumumab. Once the RPTD is determined, patients are
enrolled into the phase II portion of the study.
PHASE I (LIMITED INSTITUTIONS): Patients receive erlotinib hydrochloride orally (PO) once
daily on days 1-28, gemcitabine hydrochloride intravenously (IV) over 30 minutes on days 1,
8, and 15, and cixutumumab IV over 60 minutes on days 1, 8, 15, and 22. Treatment repeats
every 28 days in the absence of disease progression or unacceptable toxicity.
PHASE II (ALL SWOG MEMBERS): Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive erlotinib hydrochloride, gemcitabine hydrochloride, and cixutumumab
at the RPTD as in phase I.
ARM II: Patients receive erlotinib hydrochloride and gemcitabine hydrochloride as in arm I.
In both arms, treatment repeats every 28 days in the absence of disease progression or
unacceptable toxicity.
Previously collected tumor tissue is obtained for gene expression analyses by RT-PCR, RNA
isolation, and cDNA synthesis. Blood samples are collected periodically for correlative
studies. Samples are assessed for the potential relationship between gene expression levels,
germline polymorphisms, Ras and P13K mutations and progression-free survival and overall
survival.
After completion of study treatment, patients are followed every 6 months for up to 3 years.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Recommended phase II dose of cixutumumab when given in combination with gemcitabine hydrochloride and erlotinib hydrochloride (Phase I)
Toxicities will be graded according to the NCI Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE V3.0).
28 days
Yes
Philip Philip
Principal Investigator
Southwest Oncology Group
United States: Food and Drug Administration
NCI-2009-00797
NCT00617708
March 2008
Name | Location |
---|---|
Baylor College of Medicine | Houston, Texas 77030 |
University of Mississippi Medical Center | Jackson, Mississippi 39216-4505 |
Medical University of South Carolina | Charleston, South Carolina 29425-0721 |
University of Washington Medical Center | Seattle, Washington 98195-6043 |
Sinai Hospital of Baltimore | Baltimore, Maryland 21225 |
Glendale Memorial Hospital and Health Center | Glendale, California 91204 |
Sutter Health Western Division Cancer Research Group | Greenbrae, California 94904 |
South Georgia Medical Center | Valdosta, Georgia 31603 |
Akron General Medical Center | Akron, Ohio 44302 |
University of Texas Medical Branch | Galveston, Texas 77555-1329 |
LDS Hospital | Salt Lake City, Utah 84143 |
Boston Medical Center | Boston, Massachusetts 02118 |
William Beaumont Hospital | Royal Oak, Michigan 48073 |
Carolinas Medical Center | Charlotte, North Carolina 28232-2861 |
Scott and White Memorial Hospital | Temple, Texas 76508 |
Group Health Cooperative | Seattle, Washington 98112 |
Great Falls Clinic | Great Falls, Montana 59405 |
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Seattle, Washington 98109 |
Munson Medical Center | Traverse City, Michigan 49684 |
Northern Rockies Radiation Oncology Center | Billings, Montana 59101 |
Bozeman Deaconess Hospital | Bozeman, Montana 59715 |
Kalispell Medical Oncology | Kalispell, Montana 59901 |
Kalispell Regional Medical Center | Kalispell, Montana 59901 |
American Fork Hospital | American Fork, Utah 84003 |
Logan Regional Hospital | Logan, Utah 84321 |
McKay-Dee Hospital Center | Ogden, Utah 84403 |
Harborview Medical Center | Seattle, Washington 98104 |
Cancer Care Northwest - Spokane South | Spokane, Washington 99202 |
Welch Cancer Center | Sheridan, Wyoming 82801 |
University of New Mexico Cancer Center | Albuquerque, New Mexico 87131-5636 |
City of Hope Medical Center | Duarte, California 91010 |
Alta Bates Summit Medical Center - Summit Campus | Oakland, California 94609 |
Sutter Solano Medical Center | Vallejo, California 94589 |
Poudre Valley Hospital | Fort Collins, Colorado 80524 |
Saint Joseph's Hospital of Atlanta | Atlanta, Georgia 30342-1701 |
Piedmont Hospital | Atlanta, Georgia 30309 |
Gwinnett Medical Center | Lawrenceville, Georgia 30045 |
Southern Regional Medical Center | Riverdale, Georgia 30274-2600 |
Mecosta County Medical Center | Big Rapids, Michigan 49307 |
Highland General Hospital | Oakland, California 94602 |
Randolph Hospital | Asheboro, North Carolina 27203 |
Crossroads Cancer Center | Effingham, Illinois 62401 |
Menorah Medical Center | Overland Park, Kansas 66209 |
Shawnee Mission Medical Center | Shawnee Mission, Kansas 66204 |
North Kansas City Hospital | Kansas City, Missouri 64116 |
Research Medical Center | Kansas City, Missouri 64132 |
Saint Luke's East - Lee's Summit | Lee's Summit, Missouri 64086 |
Liberty Hospital | Liberty, Missouri 64068 |
Heartland Regional Medical Center | Saint Joseph, Missouri 64506 |
Bozeman Deaconess Cancer Center | Bozeman, Montana 59715 |
Northern Montana Hospital | Havre, Montana 59501 |
Wenatchee Valley Medical Center | Wenatchee, Washington 98801-2028 |
Rocky Mountain Oncology | Casper, Wyoming 82609 |
Ben Taub General Hospital | Houston, Texas 77030 |
Methodist Hospital | Houston, Texas 77030 |
Presbyterian Hospital | Charlotte, North Carolina 28233-3549 |
Metro Health Hospital | Grand Rapids, Michigan 49506 |
Guardian Oncology and Center for Wellness | Missoula, Montana 59804 |
East Bay Radiation Oncology Center | Castro Valley, California 94546 |
Contra Costa Regional Medical Center | Martinez, California 94553-3156 |
Larry G Strieff MD Medical Corporation | Oakland, California 94609 |
Saint Louis University Hospital | St. Louis, Missouri 63110-0250 |
University of Rochester | Rochester, New York 14642 |
El Camino Hospital | Mountain View, California 94040 |
Wayne State University | Detroit, Michigan 48202 |
California Pacific Medical Center | San Francisco, California 94115 |
Montana Cancer Consortium CCOP | Billings, Montana 59101 |
Decatur Memorial Hospital | Decatur, Illinois 62526 |
Montana Cancer Specialists | Missoula, Montana 59807-7877 |
Memorial Health University Medical Center | Savannah, Georgia 31404 |
University of Southern California | Los Angeles, California 90033 |
DeKalb Medical Center | Decatur, Georgia 30033 |
University of Cincinnati | Cincinnati, Ohio 45267-0502 |
Northside Hospital | Atlanta, Georgia 30342 |
Mills - Peninsula Hospitals | Burlingame, California 94010 |
Valley Medical Oncology Consultants-Castro Valley | Castro Valley, California 94546 |
Eden Hospital Medical Center | Castro Valley, California 94546 |
Valley Medical Oncology Consultants-Fremont | Fremont, California 94538 |
Bay Area Breast Surgeons Inc | Oakland, California 94609 |
Bay Area Tumor Institution CCOP | Oakland, California 94609 |
Tom K Lee Inc | Oakland, California 94609 |
Valley Medical Oncology Consultants | Pleasanton, California 94588 |
Valley Care Health System - Pleasanton | Pleasanton, California 94588 |
Doctors Medical Center- JC Robinson Regional Cancer Center | San Pablo, California 94806 |
Atlanta Regional CCOP | Atlanta, Georgia 30342 |
Well Star Cobb Hospital | Austell, Georgia 30106 |
John B Amos Cancer Center | Columbus, Georgia 31904 |
Wellstar Kennestone Hospital | Marietta, Georgia 30060 |
Saint Joseph's-Candler Health System | Savannah, Georgia 31405 |
Grand Rapids Clinical Oncology Program | Grand Rapids, Michigan 49503 |
Saint Mary's Health Care | Grand Rapids, Michigan 49503 |
Spectrum Health at Butterworth Campus | Grand Rapids, Michigan 49503 |
Mercy Health Partners-Mercy Campus | Muskegon, Michigan 49443 |
Saint Luke's Cancer Institute | Kansas City, Missouri 64111 |
Saint Luke's Hospital of Kansas City | Kansas City, Missouri 64111 |
Saint Joseph Health Center | Kansas City, Missouri 64114 |
Liberty Radiation Oncology Clinic | Kansas City, Missouri 64116 |
Truman Medical Center | Kansas City, Missouri 64108 |
Hematology-Oncology Centers of the Northern Rockies PC | Billings, Montana 59101 |
Saint Vincent Healthcare | Billings, Montana 59101 |
Billings Clinic | Billings, Montana 59107-7000 |
Saint James Community Hospital and Cancer Treatment Center | Butte, Montana 59701 |
Benefis Healthcare- Sletten Cancer Institute | Great Falls, Montana 59405 |
Berdeaux, Donald MD (UIA Investigator) | Great Falls, Montana 59405 |
Saint Peter's Community Hospital | Helena, Montana 59601 |
Glacier Oncology PLLC | Kalispell, Montana 59901 |
Community Medical Hospital | Missoula, Montana 59801 |
Saint Patrick Hospital - Community Hospital | Missoula, Montana 59802 |
Interlakes Foundation Inc-Rochester | Rochester, New York 14623 |
Highland Hospital | Rochester, New York 14620 |
Wayne Memorial Hospital | Goldsboro, North Carolina 27534 |
Margaret R Pardee Memorial Hospital | Hendersonville, North Carolina 28791 |
The Don and Sybil Harrington Cancer Center | Amarillo, Texas 79106 |
Veterans Administration Medical Center | Houston, Texas 77030 |
Saint Luke's Episcopal Hospital | Houston, Texas 77030 |
Harrison Bremerton Hematology and Oncology | Bremerton, Washington 98310 |
Columbia Basin Hematology and Oncology PLLC | Kennewick, Washington 99336 |
Minor and James Medical PLLC | Seattle, Washington 98104 |
The Polyclinic | Seattle, Washington 98122 |
Swedish Medical Center-First Hill | Seattle, Washington 98122-4307 |
University of California Medical Center At Irvine-Orange Campus | Orange, California 92868 |
Marin General Hospital | Greenbrae, California 94904 |
Harbin Clinic Medical Oncology and Clinical Research | Rome, Georgia 30165 |
Moses Cone Health System-Regional Cancer Center | Greensboro, North Carolina 27403 |
Annie Penn Memorial Hospital | Reidsville, North Carolina 27320 |
Sandra L Maxwell Cancer Center | Cedar City, Utah 84720 |
Intermountain Medical Center | Murray, Utah 84157 |
Utah Valley Regional Medical Center | Provo, Utah 84603 |
Dixie Medical Center Regional Cancer Center | Saint George, Utah 84770 |
Intermountain Health Care | Salt Lake City, Utah 84103 |
Utah Cancer Specialists-Salt Lake City | Salt Lake City, Utah 84106 |
Skagit Valley Hospital | Mt. Vernon, Washington 98273 |
Evergreen Hematology and Oncology PS | Spokane, Washington 99218 |
Saint Luke's South Hospital | Overland Park, Kansas 66213 |
Heartland Hematology and Oncology Associates Incorporated | Kansas City, Missouri 64118 |
Saint Joseph Oncology Inc | Saint Joseph, Missouri 64507 |
Arnot Ogden Medical Center | Elmira, New York 14905 |
Memorial Hospital Of Martinsville | Martinsville, Virginia 24115 |
Cancer Care Center of Decatur | Decatur, Illinois 62526 |
Alta Bates Summit Medical Center-Herrick Campus | Berkeley, California 94704 |
PeaceHealth Saint Joseph Medical Center | Bellingham, Washington 98225 |
Bronson Battle Creek | Battle Creek, Michigan 49017 |
NEA Baptist Memorial Hospital | Jonesboro, Arkansas 72401 |
Harrison Poulsbo Hematology and Oncology | Poulsbo, Washington 98370 |
Christus Saint Frances Cabrini Hospital | Alexandria, Louisiana 71301 |
Veterans Administration Medical Center - Cincinnati | Cincinnati, Ohio 45220 |