A Phase II Study of Oxaliplatin, Capecitabine, Cetuximab and Radiation in Pre-Operative Therapy of Rectal Cancer
OBJECTIVES:
- To assess the pathologic complete response rate for the combination of oxaliplatin,
capecitabine, and cetuximab alone and concurrently with external beam radiotherapy for
patients with adenocarcinoma of the rectum, stages II and III with wild-type K-ras.
- To estimate the 3-year disease-free survival probability in this patient population
when treated with this regimen.
- To assess the frequency and severity of toxicities associated with this regimen in
these patients.
- To explore, preliminarily, the association between expression levels of genes involved
in the DNA repair, EGFR (epidermal growth factor receptor), angiogenesis, and 5-FU
pathway (i.e., k-ras, TS [Thymidylate Synthase], ERCC-1 [excision repair cross
complementing-1), TP [Thymidine phosphorylase], DPD [Dihydropyrimidine dehydrogenase],
EGFR, VEGF [vascular endothelial growth factor], and IL-8 [interleukin-8]) and
pathologic complete response.
- To explore, preliminarily, the intratumoral gene expression levels of these genes after
completion of study treatment.
- To obtain, preliminarily, data on genomic polymorphisms of these genes for correlation
with clinical outcome and toxicity.
OUTLINE: This is a multicenter study.
- Neoadjuvant therapy (course 1): Patients receive oxaliplatin IV over 2 hours once a
week for 5 weeks, oral capecitabine twice daily 5 days a week for 5 weeks, and
cetuximab IV over 1-2 hours once a week for 5 weeks.
- Neoadjuvant therapy with concurrent radiotherapy (course 2): Beginning two weeks later,
patients receive oxaliplatin IV over 2 hours once a week in weeks 1, 2, 4, and 5.
Patients also receive capecitabine and cetuximab as in course 1. Patients also undergo
external beam radiotherapy 5 days a week for 5 weeks beginning in week 1.
Treatment continues in the absence of disease progression or unacceptable toxicity. Patients
undergo surgery 3-8 weeks after completion of chemoradiotherapy.
Blood samples are collected for germline polymorphism testing and tissue samples are
collected and assessed for gene expression analysis.
After completion of study treatment, patients are followed every 6 months for 4 years.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Pathologic complete response rate
15-20 weeks from registration
No
Cynthia G. Leichman, MD
Study Chair
Breastlink
United States: Federal Government
CDR0000596257
NCT00686166
February 2009
July 2017
Name | Location |
---|---|
Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |
University of Michigan Comprehensive Cancer Center | Ann Arbor, Michigan 48109-0752 |
Cardinal Bernardin Cancer Center at Loyola University Medical Center | Maywood, Illinois 60153-5500 |
Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |
CCOP - Upstate Carolina | Spartanburg, South Carolina 29303 |
CCOP - Wichita | Wichita, Kansas 67214-3882 |
CCOP - Dayton | Kettering, Ohio 45429 |
LDS Hospital | Salt Lake City, Utah 84143 |
CCOP - Grand Rapids | Grand Rapids, Michigan 49503 |
USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles, California 90033-0804 |
Veterans Affairs Medical Center - Houston | Houston, Texas 77030 |
Sutter Cancer Center | Sacramento, California 95816 |
Utah Valley Regional Medical Center - Provo | Provo, Utah 84604 |
Wesley Medical Center | Wichita, Kansas 67214 |
Arizona Cancer Center at University of Arizona Health Sciences Center | Tucson, Arizona 85724 |
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center | Kansas City, Kansas 66160-7353 |
Josephine Ford Cancer Center at Henry Ford Hospital | Detroit, Michigan 48202 |
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus | Seattle, Washington 98104 |
McDowell Cancer Center at Akron General Medical Center | Akron, Ohio 44307 |
Via Christi Cancer Center at Via Christi Regional Medical Center | Wichita, Kansas 67214 |
Alvin and Lois Lapidus Cancer Institute at Sinai Hospital | Baltimore, Maryland 21215 |
Presbyterian Cancer Center at Presbyterian Hospital | Charlotte, North Carolina 28233-3549 |
Baylor University Medical Center - Houston | Houston, Texas 77030-2399 |
Interlakes Oncology/Hematology PC | Rochester, New York 14623 |
James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester, New York 14642 |
Battle Creek Health System Cancer Care Center | Battle Creek, Michigan 49017 |
Munson Medical Center | Traverse City, Michigan 49684 |
Wayne Memorial Hospital, Incorporated | Goldsboro, North Carolina 27534 |
American Fork Hospital | American Fork, Utah 84003 |
Logan Regional Hospital | Logan, Utah 84321 |
Olympic Hematology and Oncology | Bremerton, Washington 98310 |
Skagit Valley Hospital Cancer Care Center | Mt. Vernon, Washington 98273 |
University Cancer Center at University of Washington Medical Center | Seattle, Washington 98195 |
Harborview Medical Center | Seattle, Washington 98104 |
Group Health Central Hospital | Seattle, Washington 98104 |
North Puget Oncology at United General Hospital | Sedro-Wooley, Washington 98284 |
Cancer Care Northwest - Spokane South | Spokane, Washington 99202 |
Butterworth Hospital at Spectrum Health | Grand Rapids, Michigan 49503-2560 |
University of Mississippi Cancer Clinic | Jackson, Mississippi 39216-4505 |
Decatur Memorial Hospital Cancer Care Institute | Decatur, Illinois 62526 |
Front Range Cancer Specialists | Fort Collins, Colorado 80528 |
Peninsula Medical Center | Burlingame, California 94010 |
Sutter Health - Western Division Cancer Research Group | Greenbrae, California 94904 |
Sutter Cancer Center at Roseville Medical Center | Roseville, California 95661 |
California Pacific Medical Center - California Campus | San Francisco, California 94118 |
Sutter Solano Medical Center | Vallejo, California 94589 |
Poudre Valley Hospital | Fort Collins, Colorado 80524 |
St. Francis Hospital and Health Centers - Beech Grove Campus | Beech Grove, Indiana 46107 |
Cancer Center of Kansas, PA - Dodge City | Dodge City, Kansas 67801 |
St. Francis Comprehensive Cancer Center | Topeka, Kansas 66606 |
Mecosta County Medical Center | Big Rapids, Michigan 49307 |
Iredell Memorial Hospital | Statesville, North Carolina 28677 |
Samaritan North Cancer Care Center | Dayton, Ohio 45415 |
Grandview Hospital | Dayton, Ohio 45405 |
David L. Rike Cancer Center at Miami Valley Hospital | Dayton, Ohio 45409 |
Good Samaritan Hospital | Dayton, Ohio 45406 |
Blanchard Valley Medical Associates | Findlay, Ohio 45840 |
Charles F. Kettering Memorial Hospital | Kettering, Ohio 45429 |
Middletown Regional Hospital | Middletown, Ohio 45044 |
UVMC Cancer Care Center at Upper Valley Medical Center | Troy, Ohio 45373-1300 |
Ruth G. McMillan Cancer Center at Greene Memorial Hospital | Xenia, Ohio 45385 |
Bon Secours St. Francis Health System | Greenville, South Carolina 29601 |
Dixie Regional Medical Center - East Campus | Saint George, Utah 84770 |
Polyclinic First Hill | Seattle, Washington 98122 |
Regional Cancer Center at Singing River Hospital | Pascagoula, Mississippi 39581 |
Alta Bates Summit Comprehensive Cancer Center | Berkeley, California 94704 |
Reid Hospital & Health Care Services | Richmond, Indiana 47374 |
Cancer Center of Kansas, PA - Chanute | Chanute, Kansas 66720 |
Cancer Center of Kansas - Fort Scott | Fort Scott, Kansas 66701 |
Cancer Center of Kansas-Independence | Independence, Kansas 67301 |
Cancer Center of Kansas, PA - Kingman | Kingman, Kansas 67068 |
Lawrence Memorial Hospital | Lawrence, Kansas 66044 |
Cancer Center of Kansas, PA - Liberal | Liberal, Kansas 67905 |
Cancer Center of Kansas, PA - Newton | Newton, Kansas 67114 |
Cancer Center of Kansas, PA - Parsons | Parsons, Kansas 67357 |
Cancer Center of Kansas, PA - Pratt | Pratt, Kansas 67124 |
Tammy Walker Cancer Center at Salina Regional Health Center | Salina, Kansas 67401 |
Cancer Center of Kansas, PA - Salina | Salina, Kansas 67401 |
Cancer Center of Kansas, PA - Wellington | Wellington, Kansas 67152 |
Cancer Center of Kansas, PA - Wichita | Wichita, Kansas 67214 |
Associates in Womens Health, PA - North Review | Wichita, Kansas 67208 |
Cancer Center of Kansas, PA - Medical Arts Tower | Wichita, Kansas 67208 |
Cancer Center of Kansas, PA - Winfield | Winfield, Kansas 67156 |
Truman Medical Center - Hospital Hill | Kansas City, Missouri 64108 |
Wayne Hospital | Greenville, Ohio 45331 |
Sandra L. Maxwell Cancer Center | Cedar City, Utah 84720 |
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center | Murray, Utah 84157 |
Val and Ann Browning Cancer Center at McKay-Dee Hospital Center | Ogden, Utah 84403 |
St. Joseph Cancer Center | Bellingham, Washington 98225 |
Columbia Basin Hematology | Kennewick, Washington 99336 |
Harrison Poulsbo Hematology and Onocology | Poulsbo, Washington 98370 |
Evergreen Hematology and Oncology, PS | Spokane, Washington 99218 |
Wenatchee Valley Medical Center | Wenatchee, Washington 98801-2028 |
Regional Cancer Center at Memorial Medical Center | Springfield, Illinois 62781-0001 |
Ben Taub General Hospital | Houston, Texas 77030 |
Good Samaritan Cancer Center at Good Samaritan Hospital | Kearney, Nebraska 68848-1990 |
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | Spartanburg, South Carolina 29303 |
Lacks Cancer Center at Saint Mary's Health Care | Grand Rapids, Michigan 49503 |
Roper St. Francis Cancer Center at Roper Hospital | Charleston, South Carolina 29401 |
Desert Regional Medical Center Comprehensive Cancer Center | Palm Springs, California 92262 |
Providence Cancer Center at Providence Hospital | Mobile, Alabama 36608 |
Mercy General Health Partners | Muskegon, Michigan 49443 |
AnMed Cancer Center | Anderson, South Carolina 29621 |
U.T. Medical Center Cancer Institute | Knoxville, Tennessee 37920-6999 |
Memorial Hospital Cancer Center - Colorado Springs | Colorado Springs, Colorado 80909 |
St. Luke's Texas Cancer Institute at St. Luke's Episcopal Hospital | Houston, Texas 77030 |
Mount Carmel Regional Cancer Center | Pittsburg, Kansas 66762 |
Kansas City Cancer Centers - Southwest | Overland Park, Kansas 66210 |
Hays Medical Center | Hays, Kansas 67601 |
Hutchinson Hospital Corporation | Hutchinson, Kansas 67502 |
Island Hospital Cancer Care Center at Island Hospital | Anacortes, Washington 98221 |
Highline Medical Center Cancer Center | Burien, Washington 98166 |
Southwest Regional Cancer Center - Central | Austin, Texas 78705 |
Texas Oncology, PA at Texas Oncology Cancer Center - Central | Austin, Texas 78731 |
Texas Oncology, PA at South Austin Cancer Center | Austin, Texas 78745 |
Texas Oncology, PA at Texas Cancer Center Round Rock | Round Rock, Texas 78681 |
Kansas City Cancer Centers - North | Kansas City, Missouri 64154 |
Kansas City Cancer Centers - South | Kansas City, Missouri 64131 |
Arizona Cancer Center at University Medical Center North | Tucson, Arizona 85719 |
Kansas City Cancer Centers - West | Kansas City, Kansas 66112 |
Kansas City Cancer Center - Shawnee Mission | Shawnee Mission, Kansas 66204 |
Kansas City Cancer Centers - East | Lee's Summit, Missouri 64064 |
Arizona Cancer Center at UMC Orange Grove | Tucson, Arizona 85704 |
Spectrum Health Reed City Hospital | Reed City, Michigan 49677 |
Texas Oncology, PA - Austin North | Austin, Texas 78759 |
Texas Oncology, PA - Cedar Park | Cedar Park, Texas 78613 |
Texas Oncology, PA - Seton Williamson | Round Rock, Texas 78665 |
Texas Oncology, PA - San Marcos | San Marcos, Texas 78666 |
Swedish Medical Center - Issaquah Campus | Issaquah, Washington 98029 |
Sutter Pacific Medical Foundation | Santa Rosa, California 95403 |