S0727 Gemcitabine Hydrochloride and Erlotinib Hydrochloride With or Without Monoclonal Antibody Therapy in Treating Patients With Metastatic Pancreatic Cancer That Cannot Be Removed By Surgery
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
5 other identifiers
interventional
134
1 country
146
Brief Summary
This randomized phase I/II trial is studying the side effects and best dose of monoclonal antibody therapy when given together with gemcitabine hydrochloride and erlotinib hydrochloride and to see how well they work compared with giving gemcitabine hydrochloride and erlotinib hydrochloride alone as first-line therapy in treating patients with metastatic pancreatic cancer that cannot be removed by surgery. Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving erlotinib hydrochloride and gemcitabine hydrochloride together with monoclonal antibody therapy may kill more tumor cells.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Mar 2008
Longer than P75 for phase_1
146 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 15, 2008
CompletedFirst Posted
Study publicly available on registry
February 18, 2008
CompletedStudy Start
First participant enrolled
March 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedResults Posted
Study results publicly available
December 5, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 25, 2014
CompletedFebruary 8, 2022
January 1, 2022
4.5 years
February 15, 2008
October 7, 2013
January 13, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
Maximum Tolerated Dose Determination
Maximum dose of IMC-A12 (in combination with erlotinib and gemcitabine) at which 3/10 or fewer patients have dose-limiting toxicities (DLT). Toxicities graded according to the NCI Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE 3.0). DLT apply only during cycle 1 and should be drug-related (possible, probable, or definite).
28 days
Progression-Free Survival
From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression free are censored at date of last contact.
Up to 3 years
Secondary Outcomes (3)
Overall Survival
Up to 3 years
Response
Up to 3 years
Toxicity
Up to 3 years
Study Arms (2)
Arm I (erlotinib, gemcitabine, cixutumumab)
EXPERIMENTALPatients receive erlotinib hydrochloride PO once daily on days 1-28, gemcitabine hydrochloride 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.
Arm II (erlotinib, gemcitabine)
ACTIVE COMPARATORPatients receive erlotinib hydrochloride and gemcitabine hydrochloride as in arm I. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Interventions
Given IV
Given PO
Given IV
Eligibility Criteria
You may qualify if:
- Histologically or cytologically confirmed pancreatic adenocarcinoma
- Stage IV disease (any T, any N, M1 \[distant metastases\])
- Unresectable disease
- Histologic diagnosis based on a metastatic site must be compatible with pancreatic cancer
- Measurable and/or nonmeasurable disease
- No endocrine or neuroendocrine tumors, lymphoma of the pancreas, or ampullary cancer
- No macroscopic residual disease post-resection as the only site of disease
- No clinically significant ascites
- No known brain metastases
- Patients with neurologic signs or symptoms must undergo brain imaging studies AND studies must be negative for disease
- Zubrod performance status 0-1
- ANC ≥ 1,500/mcL
- Platelet count ≥ 100,000/mcL
- Hemoglobin ≥ 9 g/dL
- Leukocytes ≥ 3,000/mcL
- +54 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (146)
NEA Baptist Memorial Hospital
Jonesboro, Arkansas, 72401, United States
Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California, 94704, United States
Mills - Peninsula Hospitals
Burlingame, California, 94010, United States
East Bay Radiation Oncology Center
Castro Valley, California, 94546, United States
Eden Hospital Medical Center
Castro Valley, California, 94546, United States
Valley Medical Oncology Consultants-Castro Valley
Castro Valley, California, 94546, United States
City of Hope Medical Center
Duarte, California, 91010, United States
Valley Medical Oncology Consultants-Fremont
Fremont, California, 94538, United States
Glendale Memorial Hospital and Health Center
Glendale, California, 91204, United States
Marin General Hospital
Greenbrae, California, 94904, United States
Sutter Health Western Division Cancer Research Group
Greenbrae, California, 94904, United States
University of Southern California
Los Angeles, California, 90033-0804, United States
Contra Costa Regional Medical Center
Martinez, California, 94553-3156, United States
El Camino Hospital
Mountain View, California, 94040, United States
Highland General Hospital
Oakland, California, 94602, United States
Alta Bates Summit Medical Center - Summit Campus
Oakland, California, 94609, United States
Bay Area Breast Surgeons Inc
Oakland, California, 94609, United States
Bay Area Tumor Institute
Oakland, California, 94609, United States
Larry G Strieff MD Medical Corporation
Oakland, California, 94609, United States
Tom K Lee Inc
Oakland, California, 94609, United States
University of California Medical Center At Irvine-Orange Campus
Orange, California, 92868, United States
Valley Care Health System - Pleasanton
Pleasanton, California, 94588, United States
Valley Medical Oncology Consultants
Pleasanton, California, 94588, United States
California Pacific Medical Center
San Francisco, California, 94118, United States
Doctors Medical Center- JC Robinson Regional Cancer Center
San Pablo, California, 94806, United States
Sutter Solano Medical Center
Vallejo, California, 94589, United States
Poudre Valley Hospital
Fort Collins, Colorado, 80524, United States
Piedmont Hospital
Atlanta, Georgia, 30309, United States
Atlanta Regional CCOP
Atlanta, Georgia, 30342, United States
Northside Hospital
Atlanta, Georgia, 30342, United States
Saint Joseph's Hospital of Atlanta
Atlanta, Georgia, 30342, United States
Well Star Cobb Hospital
Austell, Georgia, 30106, United States
John B Amos Cancer Center
Columbus, Georgia, 31904, United States
Dekalb Medical Center
Decatur, Georgia, 30033, United States
Gwinnett Medical Center
Lawrenceville, Georgia, 30045, United States
Wellstar Kennestone Hospital
Marietta, Georgia, 30060, United States
Southern Regional Medical Center
Riverdale, Georgia, 30274, United States
Harbin Clinic Medical Oncology and Clinical Research
Rome, Georgia, 30165, United States
Memorial Health University Medical Center
Savannah, Georgia, 31403, United States
Saint Joseph's-Candler Health System
Savannah, Georgia, 31405, United States
South Georgia Medical Center
Valdosta, Georgia, 31603, United States
Cancer Care Center of Decatur
Decatur, Illinois, 62526, United States
Decatur Memorial Hospital
Decatur, Illinois, 62526, United States
Crossroads Cancer Center
Effingham, Illinois, 62401, United States
Menorah Medical Center
Overland Park, Kansas, 66209, United States
Saint Luke's South Hospital
Overland Park, Kansas, 66213, United States
Shawnee Mission Medical Center
Shawnee Mission, Kansas, 66204, United States
Christus Saint Frances Cabrini Hospital
Alexandria, Louisiana, 71301, United States
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
Bronson Battle Creek
Battle Creek, Michigan, 49017, United States
Mecosta County Medical Center
Big Rapids, Michigan, 49307, United States
Wayne State University
Detroit, Michigan, 48202, United States
Grand Rapids Clinical Oncology Program
Grand Rapids, Michigan, 49503, United States
Saint Mary's Health Care
Grand Rapids, Michigan, 49503, United States
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan, 49503, United States
Mercy Health Partners-Mercy Campus
Muskegon, Michigan, 49444, United States
William Beaumont Hospital
Royal Oak, Michigan, 48073, United States
Munson Medical Center
Traverse City, Michigan, 49684, United States
Metro Health Hospital
Wyoming, Michigan, 49519, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
Truman Medical Center
Kansas City, Missouri, 64108, United States
Saint Luke's Cancer Institute
Kansas City, Missouri, 64111, United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111, United States
Saint Joseph Health Center
Kansas City, Missouri, 64114, United States
North Kansas City Hospital
Kansas City, Missouri, 64116, United States
Heartland Hematology and Oncology Associates Incorporated
Kansas City, Missouri, 64118, United States
Research Medical Center
Kansas City, Missouri, 64132, United States
Saint Luke's East - Lee's Summit
Lee's Summit, Missouri, 64086, United States
Liberty Hospital
Liberty, Missouri, 64068, United States
Liberty Radiation Oncology Clinic
Liberty, Missouri, 64068, United States
Heartland Regional Medical Center
Saint Joseph, Missouri, 64506, United States
Saint Joseph Oncology Inc
Saint Joseph, Missouri, 64507, United States
Saint Louis University Hospital
St Louis, Missouri, 63110, United States
Montana Cancer Consortium CCOP
Billings, Montana, 59101, United States
Northern Rockies Radiation Oncology Center
Billings, Montana, 59101, United States
Saint Vincent Healthcare
Billings, Montana, 59101, United States
Hematology-Oncology Centers of the Northern Rockies PC
Billings, Montana, 59102, United States
Billings Clinic
Billings, Montana, 59107-7000, United States
Bozeman Deaconess Cancer Center
Bozeman, Montana, 59715, United States
Bozeman Deaconess Hospital
Bozeman, Montana, 59715, United States
Saint James Community Hospital and Cancer Treatment Center
Butte, Montana, 59701, United States
Benefis Healthcare- Sletten Cancer Institute
Great Falls, Montana, 59405, United States
Berdeaux, Donald MD (UIA Investigator)
Great Falls, Montana, 59405, United States
Great Falls Clinic
Great Falls, Montana, 59405, United States
Northern Montana Hospital
Havre, Montana, 59501, United States
Saint Peter's Community Hospital
Helena, Montana, 59601, United States
Glacier Oncology PLLC
Kalispell, Montana, 59901, United States
Kalispell Medical Oncology
Kalispell, Montana, 59901, United States
Kalispell Regional Medical Center
Kalispell, Montana, 59901, United States
Community Medical Hospital
Missoula, Montana, 59801, United States
Montana Cancer Specialists
Missoula, Montana, 59802, United States
Saint Patrick Hospital - Community Hospital
Missoula, Montana, 59802, United States
Guardian Oncology and Center for Wellness
Missoula, Montana, 59804, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87106, United States
Arnot Ogden Medical Center
Elmira, New York, 14905, United States
Highland Hospital
Rochester, New York, 14620, United States
Interlakes Foundation Inc-Rochester
Rochester, New York, 14623, United States
University of Rochester
Rochester, New York, 14642, United States
Randolph Hospital
Asheboro, North Carolina, 27203, United States
Carolinas Medical Center
Charlotte, North Carolina, 28203, United States
Presbyterian Hospital
Charlotte, North Carolina, 28204, United States
Wayne Memorial Hospital
Goldsboro, North Carolina, 27534, United States
Cone Health Cancer Center
Greensboro, North Carolina, 27403, United States
Margaret R Pardee Memorial Hospital
Hendersonville, North Carolina, 28791, United States
Annie Penn Memorial Hospital
Reidsville, North Carolina, 27320, United States
Akron General Medical Center
Akron, Ohio, 44307, United States
Veterans Administration Medical Center - Cincinnati
Cincinnati, Ohio, 45220, United States
University of Cincinnati
Cincinnati, Ohio, 45267, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
The Don and Sybil Harrington Cancer Center
Amarillo, Texas, 79106, United States
University of Texas Medical Branch at Galveston
Galveston, Texas, 77555-0565, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Ben Taub General Hospital
Houston, Texas, 77030, United States
Methodist Hospital
Houston, Texas, 77030, United States
Saint Luke's Episcopal Hospital
Houston, Texas, 77030, United States
Veterans Administration Medical Center
Houston, Texas, 77030, United States
Scott and White Memorial Hospital
Temple, Texas, 76508, United States
American Fork Hospital
American Fork, Utah, 84003, United States
Sandra L Maxwell Cancer Center
Cedar City, Utah, 84720, United States
Logan Regional Hospital
Logan, Utah, 84321, United States
Intermountain Medical Center
Murray, Utah, 84157, United States
McKay-Dee Hospital Center
Ogden, Utah, 84403, United States
Utah Valley Regional Medical Center
Provo, Utah, 84604-3337, United States
Intermountain Health Care
Salt Lake City, Utah, 84103, United States
Utah Cancer Specialists-Salt Lake City
Salt Lake City, Utah, 84106, United States
LDS Hospital
Salt Lake City, Utah, 84143, United States
Dixie Medical Center Regional Cancer Center
St. George, Utah, 84770, United States
Memorial Hospital Of Martinsville
Martinsville, Virginia, 24115, United States
PeaceHealth Saint Joseph Medical Center
Bellingham, Washington, 98225, United States
Harrison Bremerton Hematology and Oncology
Bremerton, Washington, 98310, United States
Columbia Basin Hematology and Oncology PLLC
Kennewick, Washington, 99336, United States
Skagit Valley Hospital
Mount Vernon, Washington, 98274, United States
Harrison Poulsbo Hematology and Oncology
Poulsbo, Washington, 98370, United States
Harborview Medical Center
Seattle, Washington, 98104, United States
Minor and James Medical PLLC
Seattle, Washington, 98104, United States
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, 98109, United States
Group Health Cooperative
Seattle, Washington, 98112, United States
Swedish Medical Center-First Hill
Seattle, Washington, 98122-4307, United States
The Polyclinic
Seattle, Washington, 98122, United States
University of Washington Medical Center
Seattle, Washington, 98195, United States
Cancer Care Northwest - Spokane South
Spokane, Washington, 99202, United States
Evergreen Hematology and Oncology PS
Spokane, Washington, 99218, United States
Wenatchee Valley Medical Center
Wenatchee, Washington, 98801, United States
Rocky Mountain Oncology
Casper, Wyoming, 82609, United States
Welch Cancer Center
Sheridan, Wyoming, 82801, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Statistician
- Organization
- SWOG
Study Officials
- PRINCIPAL INVESTIGATOR
Philip Philip
SWOG Cancer Research Network
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 15, 2008
First Posted
February 18, 2008
Study Start
March 1, 2008
Primary Completion
September 1, 2012
Study Completion
February 25, 2014
Last Updated
February 8, 2022
Results First Posted
December 5, 2013
Record last verified: 2022-01