A Phase III Clinical Trial Comparing Oxaliplatin, Capecitabine and Hepatic Arterial Infusion of Floxuridine to Oxaliplatin and Capecitabine in Patients With Resected or Ablated Liver Metastases From Colorectal Cancer
OBJECTIVES:
Primary
- Compare progression-free interval (PFI) in patients undergoing surgical resection
and/or ablation for hepatic metastases from colorectal cancer treated with adjuvant
therapy comprising oxaliplatin and capecitabine with vs without hepatic arterial
infusion of floxuridine.
Secondary
- Compare overall survival and liver PFI between the two treatment groups.
- Assess toxicity in each of the treatment regimens.
- Compare self-reported symptoms between two treatment groups.
- Compare quality of life in each of the treatment regimens.
Tertiary
- Examine the prognostic worth, in terms of PFI, of specific molecular markers in hepatic
metastases.
OUTLINE: This is a randomized study. Patients are stratified according to intended surgical
technique (surgical resection alone vs cryoablation or radiofrequency ablation [RFA] alone
vs combination of resection and ablation) and prior adjuvant chemotherapy regimen
(chemotherapy with vs without oxaliplatin vs no chemotherapy). Patients are randomized to 1
of 2 treatment arms.
All patients undergo surgical resection and/or hepatic cryoablation or RFA to remove a
maximum of 6 colorectal hepatic metastases. Patients randomized to arm II also undergo
intra-arterial catheter and if applicable, pump placement.
- Arm 1 (oxaliplatin and capecitabine): Within 4-6 weeks after surgery and/or ablation,
patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily
on days 1-14. Treatment repeats every 21 days for 8 courses in the absence of disease
progression or unacceptable toxicity.
- Arm 2 (oxaliplatin, capecitabine, and hepatic arterial infusion of floxuridine): Within
4-6 weeks after surgery and/or ablation, patients receive a continuous hepatic arterial
infusion of floxuridine on days 1-14, oxaliplatin IV over 2 hours on day 22, and oral
capecitabine twice daily on days 22-35. Treatment repeats every 42 days for 4 courses
in the absence of unacceptable toxicity. Beginning with course 5, patients receive
oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-14.
Treatment with oxaliplatin and capecitabine repeats every 21 days for 4 courses in the
absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, 4-6 weeks after surgery or ablation, approximately
18 weeks after beginning of chemotherapy, and 4-6 weeks after beginning the last cycle of
chemotherapy.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 400 patients will be accrued for this study.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free Interval (PFI)
Time to first recurrence of colon cancer at any site
Time from randomization through year 5
No
Norman Wolmark, MD
Principal Investigator
NSABP Foundation, Inc.
United States: Federal Government
NSABP C-09
NCT00268463
January 2006
June 2008
Name | Location |
---|---|
Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
CCOP - Christiana Care Health Services | Wilmington, Delaware 19899 |
Saint Joseph Mercy Cancer Center | Ann Arbor, Michigan 48106-0995 |
Bronson Methodist Hospital | Kalamazoo, Michigan 49007 |
West Michigan Cancer Center | Kalamazoo, Michigan 49007-3731 |
Borgess Medical Center | Kalamazooaa, Michigan 49001 |
Natalie Warren Bryant Cancer Center at St. Francis Hospital | Tulsa, Oklahoma 74136 |
Geisinger Medical Center | Danville, Pennsylvania 17822-0001 |
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center | Madison, Wisconsin 53792-6164 |
CCOP - Ochsner | New Orleans, Louisiana 70121 |
CCOP - Columbia River Oncology Program | Portland, Oregon 97225 |
City of Hope Comprehensive Cancer Center | Duarte, California 91010 |
Fletcher Allen Health Care - University Health Center Campus | Burlington, Vermont 05401 |
Washington Cancer Institute at Washington Hospital Center | Washington, District of Columbia 20010 |
Central Baptist Hospital | Lexington, Kentucky 40503 |
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center | Savannah, Georgia 31403-3089 |
Via Christi Cancer Center at Via Christi Regional Medical Center | Wichita, Kansas 67214 |
Wake Forest University Comprehensive Cancer Center | Winston-Salem, North Carolina 27157-1096 |
Mary Babb Randolph Cancer Center at West Virginia University Hospitals | Morgantown, West Virginia 26506 |
Veterans Affairs Medical Center - Loma Linda (Pettis) | Loma Linda, California 92357 |
Harry & Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center | Baltimore, Maryland 21237 |
Kaiser Permanente Medical Center - Walnut Creek | Walnut Creek, California 94596 |
John Muir/Mt. Diablo Comprehensive Cancer Center | Walnut Creek, California 94598 |
Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center | Portland, Oregon 97210 |
Providence St. Vincent Medical Center | Portland, Oregon 97225 |
UMC Southwest Cancer and Research Center | Lubbock, Texas 79415-3364 |
Virginia Oncology Associates - Hampton | Hampton, Virginia 23666 |
Altru Cancer Center at Altru Hospital | Grand Forks, North Dakota 58201 |
St. Luke's Cancer Network at St. Luke's Hospital | Bethlehem, Pennsylvania 18015 |
Louisville Oncology at Norton Cancer Center | Louisville, Kentucky 40202 |
Cancer Care Center at John Muir Health - Concord Campus | Concord, California 94524-4110 |