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| Sponsor: | North Central Cancer Treatment Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00056030 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining chemotherapy with cetuximab may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with cetuximab works in treating patients with unresectable liver metastases from colorectal cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Cancer Metastatic Cancer |
Biological: cetuximab Drug: fluorouracil Drug: leucovorin calcium Drug: oxaliplatin |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | A Phase II Study Of Oxaliplatin (OXAL), 5-Fluorouracil (5-FU), Leucovorin (CF), and Cetuximab (C225) For Patients With Unresectable Hepatic Metastases From Metastatic Adenocarcinoma Of The Colon Or Rectum |
| Estimated Enrollment: | 73 |
| Study Start Date: | December 2004 |
| Estimated Primary Completion Date: | November 2006 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive cetuximab IV over 1 hour (over 2 hours on day 1 of course 1 only) on days 1 and 8. Patients also receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV continuously on days 1-2. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity, for a minimum of 12 courses or until deemed to have resectable disease.
Quality of life is assessed at baseline and prior to each treatment course.
Patients are followed every 3 months for 1 year and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 67-73 patients will be accrued for this study within 4 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
History of completely resected primary adenocarcinoma of the colon or rectum
Liver metastases, meeting 1 of the following criteria:
Measurable disease
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Gastrointestinal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Mobile Infirmary Medical Center | |
| Mobile, Alabama, United States, 36652-2144 | |
| United States, Arizona | |
| Mayo Clinic Scottsdale | |
| Scottsdale, Arizona, United States, 85259-5499 | |
| United States, Florida | |
| Mayo Clinic - Jacksonville | |
| Jacksonville, Florida, United States, 32224 | |
| United States, Illinois | |
| BroMenn Regional Medical Center | |
| Normal, Illinois, United States, 61761 | |
| Cancer Treatment Center at Pekin Hospital | |
| Pekin, Illinois, United States, 61554 | |
| Carle Cancer Center at Carle Foundation Hospital | |
| Urbana, Illinois, United States, 61801 | |
| CCOP - Carle Cancer Center | |
| Urbana, Illinois, United States, 61801 | |
| CCOP - Illinois Oncology Research Association | |
| Peoria, Illinois, United States, 61615 | |
| Community Cancer Center | |
| Normal, Illinois, United States, 61761 | |
| Community Hospital of Ottawa | |
| Ottawa, Illinois, United States, 61350 | |
| Hopedale Medical Complex | |
| Hopedale, Illinois, United States, 61747 | |
| Moline, Illinois, United States, 61265 | |
| Moline, Illinois, United States, 61265 | |
| Moline, Illinois, United States, 61265 | |
| Moline, Illinois, United States, 61265 | |
| Eureka Community Hospital | |
| Eureka, Illinois, United States, 61530 | |
| Galesburg Clinic, PC | |
| Galesburg, Illinois, United States, 61401 | |
| Galesburg Cottage Hospital | |
| Galesburg, Illinois, United States, 61401 | |
| Graham Hospital | |
| Canton, Illinois, United States, 61520 | |
| Moline, Illinois, United States, 61265 | |
| Illinois Valley Community Hospital | |
| Peru, Illinois, United States, 61354 | |
| Joliet Oncology-Hematology Associates, Limited - West | |
| Joliet, Illinois, United States, 60435 | |
| Kewanee Hospital | |
| Kewanee, Illinois, United States, 61443 | |
| Mason District Hospital | |
| Havana, Illinois, United States, 62644 | |
| McDonough District Hospital | |
| Macomb, Illinois, United States, 61455 | |
| Memorial Hospital | |
| Carthage, Illinois, United States, 62321 | |
| Perry Memorial Hospital | |
| Princeton, Illinois, United States, 61356 | |
| Oncology Hematology Associates of Central Illinois, PC - Ottawa | |
| Ottawa, Illinois, United States, 61350 | |
| Oncology Hematology Associates of Central Illinois, PC - Peoria | |
| Peoria, Illinois, United States, 61615 | |
| OSF St. Francis Medical Center | |
| Peoria, Illinois, United States, 61637 | |
| Methodist Medical Center of Illinois | |
| Peoria, Illinois, United States, 61636 | |
| Proctor Hospital | |
| Peoria, Illinois, United States, 61614 | |
| Rush-Copley Cancer Care Center | |
| Aurora, Illinois, United States, 60507 | |
| St. Joseph Medical Center | |
| Bloomington, Illinois, United States, 61701 | |
| St. Margaret's Hospital | |
| Spring Valley, Illinois, United States, 61362 | |
| Trinity Medical Center - East | |
| Moline, Illinois, United States, 61265 | |
| United States, Indiana | |
| Reid Hospital & Health Care Services, Incorporated | |
| Richmond, Indiana, United States, 47374 | |
| Saint Anthony Memorial Health Centers | |
| Michigan City, Indiana, United States, 46360 | |
| St. Francis Hospital and Health Centers - Beech Grove Campus | |
| Beech Grove, Indiana, United States, 46107 | |
| United States, Iowa | |
| CCOP - Iowa Oncology Research Association | |
| Des Moines, Iowa, United States, 50309 | |
| Cedar Rapids Oncology Associates | |
| Cedar Rapids, Iowa, United States, 52403 | |
| Bettendorf, Iowa, United States, 52722 | |
| John Stoddard Cancer Center at Iowa Lutheran Hospital | |
| Des Moines, Iowa, United States, 50316 | |
| John Stoddard Cancer Center at Iowa Methodist Medical Center | |
| Des Moines, Iowa, United States, 50309 | |
| McFarland Clinic, PC | |
| Ames, Iowa, United States, 50010 | |
| Medical Oncology and Hematology Associates at John Stoddard Cancer Center | |
| Des Moines, Iowa, United States, 50309 | |
| Medical Oncology and Hematology Associates at Mercy Cancer Center | |
| Des Moines, Iowa, United States, 50314 | |
| Siouxland Hematology-Oncology Associates, LLP | |
| Sioux City, Iowa, United States, 51101 | |
| Mercy Cancer Center at Mercy Medical Center - North Iowa | |
| Mason City, Iowa, United States, 50401 | |
| Mercy Capitol Hospital | |
| Des Moines, Iowa, United States, 50307 | |
| Mercy Medical Center - Sioux City | |
| Sioux City, Iowa, United States, 51104 | |
| Mercy Cancer Center at Mercy Medical Center - Des Moines | |
| Des Moines, Iowa, United States, 50314 | |
| St. Luke's Regional Medical Center | |
| Sioux City, Iowa, United States, 51104 | |
| United States, Kansas | |
| Associates in Womens Health, PA - North Review | |
| Wichita, Kansas, United States, 67203 | |
| Cancer Center of Kansas, PA - Kingman | |
| Kingman, Kansas, United States, 67068 | |
| Cancer Center of Kansas, PA - Wichita | |
| Wichita, Kansas, United States, 67214 | |
| Cancer Center of Kansas, PA - Chanute | |
| Chanute, Kansas, United States, 66720 | |
| Cancer Center of Kansas, PA - Parsons | |
| Parsons, Kansas, United States, 67357 | |
| Cancer Center of Kansas, PA - El Dorado | |
| El Dorado, Kansas, United States, 67042 | |
| Cancer Center of Kansas, PA - Medical Arts Tower | |
| Wichita, Kansas, United States, 67208 | |
| Cancer Center of Kansas, PA - Newton | |
| Newton, Kansas, United States, 67114 | |
| Cancer Center of Kansas, PA - Dodge City | |
| Dodge City, Kansas, United States, 67801 | |
| Cancer Center of Kansas, PA - Pratt | |
| Pratt, Kansas, United States, 67124 | |
| Cancer Center of Kansas, PA - Salina | |
| Salina, Kansas, United States, 67042 | |
| Cancer Center of Kansas, PA - Wellington | |
| Wellington, Kansas, United States, 67152 | |
| Cancer Center of Kansas, PA - Winfield | |
| Winfield, Kansas, United States, 67156 | |
| CCOP - Wichita | |
| Wichita, Kansas, United States, 67214 | |
| Southwest Medical Center | |
| Liberal, Kansas, United States, 67901 | |
| Via Christi Cancer Center at Via Christi Regional Medical Center | |
| Wichita, Kansas, United States, 67214 | |
| United States, Michigan | |
| Community Cancer Center of Monroe | |
| Monroe, Michigan, United States, 48162 | |
| Dickinson County Healthcare System | |
| Iron Mountain, Michigan, United States, 49801 | |
| Green Bay Oncology, Limited - Escanaba | |
| Escanaba, Michigan, United States, 49431 | |
| Haematology-Oncology Associates of Ohio and Michigan, PC | |
| Lambertville, Michigan, United States, 48144 | |
| Hickman Cancer Center at Bixby Medical Center | |
| Adrian, Michigan, United States, 49221 | |
| Mercy Memorial Hospital - Monroe | |
| Monroe, Michigan, United States, 48162 | |
| United States, Minnesota | |
| CCOP - Duluth | |
| Duluth, Minnesota, United States, 55805 | |
| CCOP - Metro-Minnesota | |
| Saint Louis Park, Minnesota, United States, 55416 | |
| CentraCare Clinic - River Campus | |
| St. Cloud, Minnesota, United States, 56303 | |
| Fairview Southdale Hospital | |
| Edina, Minnesota, United States, 55435 | |
| Coborn Cancer Center | |
| Saint Cloud, Minnesota, United States, 56303 | |
| Duluth Clinic Cancer Center - Duluth | |
| Duluth, Minnesota, United States, 55805-1983 | |
| Fairview Ridges Hospital | |
| Burnsville, Minnesota, United States, 55337 | |
| Chippewa County - Montevideo Hospital and Medical Center | |
| Montevideo, Minnesota, United States, 56265 | |
| HealthEast Cancer Care at St. John's Hospital | |
| Maplewood, Minnesota, United States, 55109 | |
| HealthEast Cancer Care at St. Joseph's Hospital | |
| St Paul, Minnesota, United States, 55102 | |
| HealthEast Cancer Care at Woodwinds Health Campus | |
| Woodbury, Minnesota, United States, 55125 | |
| Hennepin County Medical Center - Minneapolis | |
| Minneapolis, Minnesota, United States, 55415 | |
| Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center | |
| Robbinsdale, Minnesota, United States, 55422-2900 | |
| Hutchinson Area Health Care | |
| Hutchinson, Minnesota, United States, 55350 | |
| Mayo Clinic Cancer Center | |
| Rochester, Minnesota, United States, 55905 | |
| Meeker County Memorial Hospital | |
| Lichfield, Minnesota, United States, 55355 | |
| Mercy and Unity Cancer Center at Mercy Hospital | |
| Coon Rapids, Minnesota, United States, 55433 | |
| Mercy and Unity Cancer Center at Unity Hospital | |
| Fridley, Minnesota, United States, 55432 | |
| MeritCare Bemidji | |
| Bemidji, Minnesota, United States, 56601 | |
| Fergus Falls, Minnesota, United States, 56537 | |
| Minnesota Oncology Hematology, PA - Maplewood | |
| Maplewood, Minnesota, United States, 55109 | |
| Minnesota Oncology Hematology, PA - Woodbury | |
| Woodbury, Minnesota, United States, 55125 | |
| Park Nicollet Cancer Center | |
| St. Louis Park, Minnesota, United States, 55416 | |
| Regions Hospital Cancer Care Center | |
| St. Paul, Minnesota, United States, 55101 | |
| Ridgeview Medical Center | |
| Waconia, Minnesota, United States, 55387 | |
| St. Francis Cancer Center at St. Francis Medical Center | |
| Shakopee, Minnesota, United States, 55379 | |
| United Hospital | |
| St. Paul, Minnesota, United States, 55102 | |
| Virginia Piper Cancer Institute at Abbott - Northwestern Hospital | |
| Minneapolis, Minnesota, United States, 55407 | |
| Miller - Dwan Medical Center | |
| Duluth, Minnesota, United States, 55805 | |
| Alexandria, Minnesota, United States, 56308 | |
| Fergus Falls, Minnesota, United States, 56537 | |
| United States, Montana | |
| Big Sky Oncology | |
| Great Falls, Montana, United States, 59405-5309 | |
| United States, Nebraska | |
| Alegant Health Cancer Center at Bergan Mercy Medical Center | |
| Omaha, Nebraska, United States, 68124 | |
| CCOP - Missouri Valley Cancer Consortium | |
| Omaha, Nebraska, United States, 68106 | |
| Creighton University Medical Center | |
| Omaha, Nebraska, United States, 68131-2197 | |
| Immanuel Medical Center | |
| Omaha, Nebraska, United States, 68122 | |
| United States, North Carolina | |
| Rutherford Hospital | |
| Rutherfordton, North Carolina, United States, 28139 | |
| United States, North Dakota | |
| Altru Cancer Center at Altru Hospital | |
| Grand Forks, North Dakota, United States, 58201 | |
| Bismarck Cancer Center | |
| Bismarck, North Dakota, United States, 58501 | |
| CCOP - MeritCare Hospital | |
| Fargo, North Dakota, United States, 58122 | |
| Medcenter One Hospital Cancer Care Center | |
| Bismarck, North Dakota, United States, 58501 | |
| MeritCare Broadway | |
| Fargo, North Dakota, United States, 58122 | |
| Mid Dakota Clinic, PC | |
| Bismarck, North Dakota, United States, 58501 | |
| St. Alexius Medical Center Cancer Center | |
| Bismarck, North Dakota, United States, 58502 | |
| United States, Ohio | |
| Blanchard Valley Medical Associates | |
| Findlay, Ohio, United States, 45840 | |
| Firelands Regional Medical Center | |
| Sandusky, Ohio, United States, 44870 | |
| CCOP - Toledo Community Hospital | |
| Toledo, Ohio, United States, 43617 | |
| Charles F. Kettering Memorial Hospital | |
| Kettering, Ohio, United States, 45429 | |
| David L. Rike Cancer Center at Miami Valley Hospital | |
| Dayton, Ohio, United States, 45409 | |
| CCOP - Dayton | |
| Dayton, Ohio, United States, 45429 | |
| Flower Hospital Cancer Center | |
| Sylvania, Ohio, United States, 43560 | |
| Fremont Memorial Hospital | |
| Fremont, Ohio, United States, 43420 | |
| Fulton County Health Center | |
| Wauseon, Ohio, United States, 43567 | |
| Good Samaritan Hospital | |
| Dayton, Ohio, United States, 45406 | |
| Grandview Hospital | |
| Dayton, Ohio, United States, 45405 | |
| Lima Memorial Hospital | |
| Lima, Ohio, United States, 45804 | |
| Medical University of Ohio Cancer Center | |
| Toledo, Ohio, United States, 43614 | |
| Mercy Hospital of Tiffin | |
| Tiffin, Ohio, United States, 44883 | |
| Middletown Regional Hospital | |
| Middletown, Ohio, United States, 45044 | |
| North Coast Cancer Care, Incorporated | |
| Sandusky, Ohio, United States, 44870 | |
| Northwest Ohio Oncology Center | |
| Maumee, Ohio, United States, 43537 | |
| Veterans Affairs Medical Center - Dayton | |
| Dayton, Ohio, United States, 45428 | |
| Samaritan North Cancer Care Center | |
| Dayton, Ohio, United States, 45415 | |
| St. Charles Mercy Hospital | |
| Oregon, Ohio, United States, 43616 | |
| St. Luke's Hospital | |
| Maumee, Ohio, United States, 43537 | |
| St. Vincent Mercy Medical Center | |
| Toledo, Ohio, United States, 43608 | |
| Toledo Clinic - Oregon | |
| Oregon, Ohio, United States, 43616 | |
| Toledo Clinic, Incorporated - Main Clinic | |
| Toledo, Ohio, United States, 43623 | |
| Toledo Hospital | |
| Toledo, Ohio, United States, 43606 | |
| UVMC Cancer Care Center at Upper Valley Medical Center | |
| Troy, Ohio, United States, 45373-1300 | |
| Ruth G. McMillan Cancer Center at Greene Memorial Hospital | |
| Xenia, Ohio, United States, 45385 | |
| Wood County Oncology Center | |
| Bowling Green, Ohio, United States, 43402 | |
| United States, Pennsylvania | |
| Allegheny Cancer Center at Allegheny General Hospital | |
| Pittsburgh, Pennsylvania, United States, 15212 | |
| Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center | |
| Wilkes-Barre, Pennsylvania, United States, 18711 | |
| Geisinger Medical Center | |
| Danville, Pennsylvania, United States, 17822-0001 | |
| Geisinger Medical Group - Scenery Park | |
| State College, Pennsylvania, United States, 16801 | |
| Guthrie Cancer Center at Guthrie Clinic Sayre | |
| Sayre, Pennsylvania, United States, 18840 | |
| Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest | |
| Allentown, Pennsylvania, United States, 18105 | |
| United States, South Carolina | |
| AnMed Cancer Center | |
| Anderson, South Carolina, United States, 29621 | |
| CCOP - Upstate Carolina | |
| Spartanburg, South Carolina, United States, 29303 | |
| Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | |
| Spartanburg, South Carolina, United States, 29303 | |
| United States, South Dakota | |
| Avera Cancer Institute | |
| Sioux Falls, South Dakota, United States, 57105 | |
| Medical X-Ray Center, PC | |
| Sioux Falls, South Dakota, United States, 57105 | |
| Sanford Cancer Center at Sanford USD Medical Center | |
| Sioux Falls, South Dakota, United States, 57117-5039 | |
| United States, Virginia | |
| Fredericksburg Oncology, Incorporated | |
| Fredericksburg, Virginia, United States, 22401 | |
| United States, Wisconsin | |
| Bay Area Cancer Care Center at Bay Area Medical Center | |
| Marinette, Wisconsin, United States, 54143 | |
| Green Bay Oncology, Limited - Oconto Falls | |
| Oconto Falls, Wisconsin, United States, 54154 | |
| St. Vincent Hospital Regional Cancer Center | |
| Green Bay, Wisconsin, United States, 54307-3508 | |
| Green Bay Oncology, Limited at St. Mary's Hospital | |
| Green Bay, Wisconsin, United States, 54303 | |
| Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center | |
| Green Bay, Wisconsin, United States, 54301-3526 | |
| St. Mary's Hospital Medical Center - Green Bay | |
| Green Bay, Wisconsin, United States, 54303 | |
| Green Bay Oncology, Limited - Sturgeon Bay | |
| Sturgeon Bay, Wisconsin, United States, 54235 | |
| Study Chair: | Steven R. Alberts, MD | Mayo Clinic |
More Information
| Responsible Party: | North Central Cancer Treatment Group ( Jan C. Buckner ) |
| Study ID Numbers: | CDR0000271923, NCCTG-N014A |
| Study First Received: | March 6, 2003 |
| Last Updated: | April 14, 2009 |
| ClinicalTrials.gov Identifier: | NCT00056030 History of Changes |
| Health Authority: | United States: Federal Government |
|
liver metastases stage IV colon cancer stage IV rectal cancer adenocarcinoma of the colon adenocarcinoma of the rectum |
|
Antimetabolites Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Gastrointestinal Diseases Physiological Effects of Drugs Colonic Diseases Leucovorin Rectal Diseases Neoplastic Processes Oxaliplatin Neoplasms by Site Pathologic Processes Vitamins |
Therapeutic Uses Neoplasm Metastasis Micronutrients Vitamin B Complex Digestive System Neoplasms Neoplasms by Histologic Type Growth Substances Cetuximab Intestinal Diseases Immunosuppressive Agents Pharmacologic Actions Intestinal Neoplasms Carcinoma Neoplasms Digestive System Diseases |