Phase II Study of Treatment Selection Based Upon Tumor Thymidylate Synthase Expression in Previously Untreated Patients With Metastatic Colorectal Cancer
OBJECTIVES:
- Compare the response rate (complete and partial), progression-free survival, and
overall survival of patients with previously untreated metastatic or locally recurrent
colorectal adenocarcinoma with high vs low thymidylate synthase (TS) expression treated
with fluorouracil, leucovorin calcium, oxaliplatin, and bevacizumab or irinotecan,
oxaliplatin, and bevacizumab.
- Compare the toxicity of these regimens in these patients.
- Correlate gene expression with response rates in patients treated with these regimens.
- Correlate gene expression with toxicity of these regimens in these patients.
- Correlate dihydropyrimidine dehydrogenase, thymidine phosphorylase, and mammalian
excision repair cross complementary protein expression with antitumor response in
patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
thymidylate synthase (TS) expression levels (high vs low or indeterminate). Patients with
high TS expression are randomized to 1 of 2 treatment arms (arms I or II). Patients with low
or indeterminate TS expression are assigned to arm III.
- Arm I: Patients receive bevacizumab IV over 30-90 minutes followed by oxaliplatin IV
over 2 hours and irinotecan IV over 90 minutes on days 1 and 15.
- Arm II: Patients receive bevacizumab and oxaliplatin as in arm I, leucovorin calcium IV
over 2 hours, and fluorouracil IV over 5 minutes and then continuously over 46 hours on
days 1 and 15.
- Arm III: Patients receive bevacizumab, oxaliplatin, leucovorin calcium, and
fluorouracil as in arm II.
In all arms, courses repeat every 28 days in the absence of unacceptable toxicity or disease
progression.
Patients are followed up every 3 months for 2 years and then every 6 months for 2 years from
the date of study registration.
PROJECTED ACCRUAL: A total of 117-246 patients (40-72 in arm I, 40-72 in arm II, 37-102 in
arm III) will be accrued for this study within 14-23 months.
Interventional
Allocation: Randomized, Primary Purpose: Treatment
Response rate (complete response [CR] and partial response [PR]) as measured by RECIST
No
Neal J. Meropol, MD
Study Chair
Fox Chase Cancer Center
United States: Federal Government
CDR0000398096
NCT00098787
July 2005
Name | Location |
---|---|
CCOP - Missouri Valley Cancer Consortium | Omaha, Nebraska 68131 |
Veterans Affairs Medical Center - Atlanta (Decatur) | Decatur, Georgia 30033 |
CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
Aurora Presbyterian Hospital | Aurora, Colorado 80012 |
Boulder Community Hospital | Boulder, Colorado 80301-9019 |
Penrose Cancer Center at Penrose Hospital | Colorado Springs, Colorado 80933 |
CCOP - Colorado Cancer Research Program | Denver, Colorado 80224-2522 |
Porter Adventist Hospital | Denver, Colorado 80210 |
Presbyterian - St. Luke's Medical Center | Denver, Colorado 80218 |
St. Joseph Hospital | Denver, Colorado 80218 |
Rose Medical Center | Denver, Colorado 80220 |
Swedish Medical Center | Englewood, Colorado 80110 |
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center | Grand Junction, Colorado 81502 |
Sky Ridge Medical Center | Lone Tree, Colorado 80124 |
Hope Cancer Care Center at Longmont United Hospital | Longmont, Colorado 80502 |
St. Mary - Corwin Regional Medical Center | Pueblo, Colorado 81004 |
North Suburban Medical Center | Thornton, Colorado 80229 |
Mercy Medical Center - Sioux City | Sioux City, Iowa 51104 |
Siouxland Hematology-Oncology Associates, LLP | Sioux City, Iowa 51101 |
St. Luke's Regional Medical Center | Sioux City, Iowa 51104 |
Bronson Methodist Hospital | Kalamazoo, Michigan 49007 |
West Michigan Cancer Center | Kalamazoo, Michigan 49007-3731 |
Borgess Medical Center | Kalamazooaa, Michigan 49001 |
MeritCare Bemidji | Bemidji, Minnesota 56601 |
Fairview Ridges Hospital | Burnsville, Minnesota 55337 |
Mercy and Unity Cancer Center at Mercy Hospital | Coon Rapids, Minnesota 55433 |
Fairview Southdale Hospital | Edina, Minnesota 55435 |
Mercy and Unity Cancer Center at Unity Hospital | Fridley, Minnesota 55432 |
Hutchinson Area Health Care | Hutchinson, Minnesota 55350 |
HealthEast Cancer Care at St. John's Hospital | Maplewood, Minnesota 55109 |
Hennepin County Medical Center - Minneapolis | Minneapolis, Minnesota 55415 |
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital | Minneapolis, Minnesota 55407 |
St. Francis Cancer Center at St. Francis Medical Center | Shakopee, Minnesota 55379 |
Park Nicollet Cancer Center | St. Louis Park, Minnesota 55416 |
Regions Hospital Cancer Care Center | St. Paul, Minnesota 55101 |
United Hospital | St. Paul, Minnesota 55102 |
Ridgeview Medical Center | Waconia, Minnesota 55387 |
CCOP - MeritCare Hospital | Fargo, North Dakota 58122 |
Case Comprehensive Cancer Center | Cleveland, Ohio 44106-5065 |
MetroHealth Cancer Care Center at MetroHealth Medical Center | Cleveland, Ohio 44109 |
St. Rita's Medical Center | Lima, Ohio 45801 |
Natalie Warren Bryant Cancer Center at St. Francis Hospital | Tulsa, Oklahoma 74136 |
Sanford Cancer Center at Sanford USD Medical Center | Sioux Falls, South Dakota 57117-5039 |
Avera Cancer Institute | Sioux Falls, South Dakota 57105 |
Memorial Hospital of South Bend | South Bend, Indiana 46601 |
CCOP - Columbus | Columbus, Ohio 43206 |
CCOP - Northern Indiana CR Consortium | South Bend, Indiana 46601 |
Saint Joseph Regional Medical Center | South Bend, Indiana 46617 |
CCOP - Scott and White Hospital | Temple, Texas 76508 |
University of Florida Shands Cancer Center | Gainesville, Florida 32610-0232 |
Winship Cancer Institute of Emory University | Atlanta, Georgia 30322 |
McCreery Cancer Center at Ottumwa Regional | Ottumwa, Iowa 52501 |
North Colorado Medical Center | Greeley, Colorado 80631 |
McKee Medical Center | Loveland, Colorado 80539 |
Adena Regional Medical Center | Chillicothe, Ohio 54601 |
Doctors Hospital at Ohio Health | Columbus, Ohio 43228 |
Riverside Methodist Hospital Cancer Care | Columbus, Ohio 43214 |
Grady Memorial Hospital | Delaware, Ohio 43015 |
Fairfield Medical Center | Lancaster, Ohio 43130 |
Strecker Cancer Center at Marietta Memorial Hospital | Marietta, Ohio 45750 |
Licking Memorial Cancer Care Program at Licking Memorial Hospital | Newark, Ohio 43055 |
Community Hospital of Springfield and Clark County | Springfield, Ohio 45505 |
Genesis - Good Samaritan Hospital | Zanesville, Ohio 43701 |
Swedish-American Regional Cancer Center | Rockford, Illinois 61104-2315 |
Indiana University Melvin and Bren Simon Cancer Center | Indianapolis, Indiana 46202-5289 |
Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Chicago, Illinois 60611 |
Decatur Memorial Hospital Cancer Care Institute | Decatur, Illinois 62526 |
Elkhart General Hospital | Elkhart, Indiana 46515 |
Howard Community Hospital | Kokomo, Indiana 46904 |
Lakeland Regional Cancer Care Center - St. Joseph | St. Joseph, Michigan 49085 |
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton | Marlton, New Jersey 08053 |
Mount Carmel Health - West Hospital | Columbus, Ohio 43222 |
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest | Allentown, Pennsylvania 18105 |
Fox Chase Cancer Center - Philadelphia | Philadelphia, Pennsylvania 19111-2497 |
Hematology Oncology Associates - Skokie | Skokie, Illinois 60076 |
Hematology and Oncology Associates | Chicago, Illinois 60611 |
North Shore Oncology and Hematology Associates, Limited - Libertyville | Libertyville, Illinois 60048 |
Center for Cancer Therapy at LaPorte Hospital and Health Services | La Porte, Indiana 46350 |
Immanuel Medical Center | Omaha, Nebraska 68122 |
Creighton University Medical Center | Omaha, Nebraska 68131-2197 |
Bryn Mawr Hospital | Bryn Mawr, Pennsylvania 19010 |
Lankenau Cancer Center at Lankenau Hospital | Wynnewood, Pennsylvania 19096 |
St. Anthony Central Hospital | Denver, Colorado 80204-1335 |
Exempla Lutheran Medical Center | Wheat Ridge, Colorado 80033 |
Cancer Resource Center - Lincoln | Lincoln, Nebraska 68510 |
Saint Joseph Hospital | Chicago, Illinois 60657 |
Cancer Care and Hematology Specialists of Chicagoland - Niles | Niles, Illinois 60714 |
William N. Wishard Memorial Hospital | Indianapolis, Indiana 46202 |
Lakeside Cancer Specialists, PLLC | Saint Joseph, Michigan 49085 |
Willmar Cancer Center at Rice Memorial Hospital | Willmar, Minnesota 56201 |
Alegant Health Cancer Center at Bergan Mercy Medical Center | Omaha, Nebraska 68124 |
Grant Medical Center Cancer Care | Columbus, Ohio 43215 |
Knox Community Hospital | Mount Vernon, Ohio 43050 |
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center | Reading, Pennsylvania 19612-6052 |
Veterans Affairs Medical Center - Indianapolis | Indianapolis, Indiana 46202 |
Cancer Center of Paoli Memorial Hospital | Paoli, Pennsylvania 19301-1792 |
CCOP - Main Line Health | Wynnewood, Pennsylvania 19096 |
Provena St. Mary's Regional Cancer Center - Kankakee | Kankakee, Illinois 60901 |
Minnesota Oncology - Maplewood | Maplewood, Minnesota 55109 |
Humphrey Cancer Center at North Memorial Outpatient Center | Robbinsdale, Minnesota 55422-2900 |
Lakeview Hospital | Stillwater, Minnesota 55082 |
Minnesota Oncology - Woodbury | Woodbury, Minnesota 55125 |
California Cancer Care, Incorporated - Greenbrae | Greenbrae, California 94904 |
Erlanger Cancer Center at Erlanger Hospital - Baroness | Chattanooga, Tennessee 37403 |
Lakeside Hospital | Omaha, Nebraska 68130 |
Littleton Adventist Hospital | Littleton, Colorado 80122 |
Parker Adventist Hospital | Parker, Colorado 80138 |
New Ulm Medical Center | New Ulm, Minnesota 56073 |
Roger Maris Cancer Center at MeritCare Hospital | Fargo, North Dakota 58122 |
Southern Ohio Medical Center Cancer Center | Portsmouth, Ohio 45662 |