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A Multicenter, Open-Label, Randomized, Three-Arm Study Of 5-Fluorouracil (5-FU) Plus Leucovorin (LV) Or Oxaliplatin Or A Combination Of (5-Fu) LV + Oxaliplatin As Second-Line Treatment Of Metastatic Colorectal Carcinoma

Phase 3
18 Years
Open (Enrolling)
Colorectal Cancer

Thank you

Trial Information

A Multicenter, Open-Label, Randomized, Three-Arm Study Of 5-Fluorouracil (5-FU) Plus Leucovorin (LV) Or Oxaliplatin Or A Combination Of (5-Fu) LV + Oxaliplatin As Second-Line Treatment Of Metastatic Colorectal Carcinoma

OBJECTIVES: I. Compare the overall survival of patients with metastatic colorectal carcinoma
treated with fluorouracil and leucovorin calcium with vs without oxaliplatin vs oxaliplatin
alone. II. Compare the response rate, time to tumor-related symptomatic worsening, time to
disease progression, onset and duration of complete and partial responses, and duration of
disease stabilization in patients treated with these regimens. III. Determine the safety
profile of these regimens in these patients.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified
according to Karnofsky performance status (50-60% vs 70-100%), number of metastatic organs
(1 vs 2 or more), and LDH value (up to 1.5 times upper limit of normal (ULN) vs greater than
1.5 times ULN). Patients are randomized to one of three treatment arms. Arm I: Patients
receive leucovorin calcium IV over 2 hours followed by fluorouracil IV continuously over 22
hours on days 1 and 2. Arm II: Patients receive oxaliplatin IV over 2 hours on day 1. Arm
III: Patients receive oxaliplatin IV concurrently with leucovorin calcium IV over 2 hours
followed by fluorouracil IV continuously over 22 hours on day 1. Leucovorin calcium and
fluorouracil are administered alone on day 2 on the same schedule as on day 1. Treatment
repeats every 2 weeks for up to 1 year in the absence of disease progression or unacceptable
toxicity. Patients are followed for 30 days, every 2 weeks for up to 3 months, and then
every 3 months thereafter.

PROJECTED ACCRUAL: A total of 786 patients (262 per arm) will be accrued for this study
within 12 months.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed metastatic
adenocarcinoma of the colon or rectum that is not amenable to potentially curative therapy
(e.g., inoperable metastatic disease) At least 1 unidimensionally measurable lesion at
least 20 mm in diameter by conventional CT or MRI scan or at least 10 mm in diameter by
spiral CT scan Progressive disease by CT or MRI scan during or no more than 6 months after
the last dose of prior first-line irinotecan, fluorouracil, and leucovorin calcium (Saltz
regimen) for metastatic disease

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 50-100% Life
expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3
Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper
limit of normal (ULN) AST and ALT no greater than 2 times ULN (no greater than 5 times ULN
if liver metastases present) Alkaline phosphatase no greater than 2 times ULN (no greater
than 3 times ULN if liver metastases present) Renal: Creatinine no greater than 1.5 times
ULN Cardiovascular: No uncontrolled high blood pressure No unstable angina, symptomatic
congestive heart failure, or serious cardiac arrhythmia No New York Heart Association
class III or IV heart disease No history of cardiac toxicities with prior fluorouracil and
leucovorin calcium No myocardial infarction within the past 6 months Pulmonary: No
interstitial pneumonia or extensive and symptomatic fibrosis of the lung Other: Not
pregnant or nursing Negative pregnancy test Fertile patients must use effective
contraception during and for 6 months after study No known dihydropyrimidine dehydrogenase
deficiency No allergy to platinum-containing drugs No history of intolerance to study
anti-emetics (e.g., 5-HT3 antagonists) No known peripheral neuropathy (absence of deep
tendon reflexes as sole deficiency allowed) No uncontrolled diabetes No active infection
No other active malignancy originating from primary site other than colon or rectum

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease
Characteristics One and only 1 prior chemotherapy regimen for metastatic disease
consisting of first-line irinotecan, fluorouracil, and leucovorin calcium (Saltz regimen)
Prior adjuvant fluorouracil with leucovorin calcium allowed At least 3 weeks since prior
chemotherapy for metastatic disease and recovered No prior adjuvant irinotecan No prior
oxaliplatin Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to study
lesions unless evidence of progressive disease within the radiotherapy port At least 3
weeks since prior radiotherapy Surgery: See Disease Characteristics At least 4 weeks since
prior major surgery and recovered Prior surgical resection of primary tumor or metastases
allowed Other: At least 30 days since prior investigational drugs No other concurrent
investigational agents No other concurrent anti-cancer therapy No concurrent participation
in other investigational trials

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Mace L. Rothenberg, MD, FACP

Investigator Role:

Study Chair

Investigator Affiliation:

Vanderbilt-Ingram Cancer Center


United States: Federal Government

Study ID:




Start Date:

October 2000

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • stage IV colon cancer
  • stage IV rectal cancer
  • recurrent colon cancer
  • recurrent rectal cancer
  • adenocarcinoma of the colon
  • adenocarcinoma of the rectum
  • Colorectal Neoplasms



Roswell Park Cancer Institute Buffalo, New York  14263
Albert Einstein Comprehensive Cancer Center Bronx, New York  10461
Albert B. Chandler Medical Center, University of Kentucky Lexington, Kentucky  40536-0084
Barbara Ann Karmanos Cancer Institute Detroit, Michigan  48201
Cooper Hospital/University Medical Center Camden, New Jersey  08103
State University of New York Health Sciences Center - Stony Brook Stony Brook, New York  11790-7775
Lineberger Comprehensive Cancer Center, UNC Chapel Hill, North Carolina  27599-7295
Abington Memorial Hospital Abington, Pennsylvania  19001
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia Philadelphia, Pennsylvania  19107
University of Pennsylvania Cancer Center Philadelphia, Pennsylvania  19104
Simmons Cancer Center - Dallas Dallas, Texas  75235-9154
University of Pittsburgh Cancer Institute Pittsburgh, Pennsylvania  15213
Baptist Regional Cancer Center - Knoxville Knoxville, Tennessee  37901
Vanderbilt-Ingram Cancer Center Nashville, Tennessee  37232-6838
NYU School of Medicine's Kaplan Comprehensive Cancer Center New York, New York  10016
Lombardi Cancer Center Washington, District of Columbia  20007
Huntsman Cancer Institute Salt Lake City, Utah  84112
University of Florida Health Science Center Gainesville, Florida  32610-0296
Lutheran General Cancer Care Center Park Ridge, Illinois  60068
James Graham Brown Cancer Center Louisville, Kentucky  40202
Veterans Affairs Medical Center - Albany Albany, New York  12208
New York Medical College Valhalla, New York  10595
Virginia Mason Medical Center Seattle, Washington  98111
University of Wisconsin Comprehensive Cancer Center Madison, Wisconsin  53792
Texas Oncology, P.A. Dallas, Texas  75246
University of Kansas Medical Center Kansas City, Kansas  66160-7353
Kaiser Permanente Medical Center - Vallejo Vallejo, California  94589
Virginia Oncology Associates - Newport News Newport News, Virginia  23606
Comprehensive Cancer Institute of Huntsville Huntsville, Alabama  35801
Florida Hospital Cancer Institute Orlando, Florida  32804
Memorial Regional Hospital Comprehensive Cancer Center Hollywood, Florida  33021
California Cancer Care, Inc. Greenbrae, California  94904-2007
Hematology Oncology Consultants Inc Columbus, Ohio  43235
Kaiser Permanente-Southern California Permanente Medical Group San Diego, California  92120
Columbia Comprehensive Cancer Care Clinic Columbia, Missouri  65201
Interlakes Oncology/Hematology PC Rochester, New York  14623
Rocky Mountain Cancer Center Denver, Colorado  80218
Oncology-Hematology Group of South Florida Miami, Florida  33176
Louisiana State University School of Medicine New Orleans, Louisiana  70112-2822
Texas Oncology PA (TOPA) at Baylor-Sammons Dallas, Texas  75246
Ocala Oncology Center Ocala, Florida  34474
Cancer Centers of the Carolinas Greenville, South Carolina  29605
Mount Sinai Comprehensive Cancer Center Miami Beach, Florida  33140
Oncology Center at Providence Park Mobile, Alabama  36608
St. Vincents Comprehensive Cancer Center New York, New York  10011
Florida Cancer Specialists Fort Myers, Florida  33901
Louisiana Oncology Associates Lafayette, Louisiana  70506
Lone Star Oncology Austin, Texas  78759
Maine Center for Cancer Medicine and Blood Disorders Scarborough, Maine  04074
Park Nicollet Clinic St. Louis Park, Minnesota  55416
Northwestern Connecticut Oncology-Hematology Associates Torrington, Connecticut  06790
Hematology Oncology Associates of Illinois-Highland Park Highland Park, Illinois  60035
Cancer Center of Kansas - Wichita Wichita, Kansas  67214
UW Cancer Center Wausau Hospital Wausau, Wisconsin  54401
Missouri Cancer Associates Columbia, Missouri  65201
Missouri Baptist Cancer Center St. Louis, Missouri  63131
Kaiser Permanente - Denver Denver, Colorado  80205
Cancer Care Center New Albany, Indiana  47150
Cancer and Blood Institute of the Desert Rancho Mirage, California  92270
Midwest Oncology Consortium Kansas City, Missouri  64111
St. John's Mercy Medical Center Saint Louis, Missouri  63141
Lakeland Regional Medical Center Lakeland, Florida  33804
Baton Rouge General Medical Center Baton Rouge, Louisiana  70821-2511
Arizona Clinical Research Center Tucson, Arizona  85712
Pennsylvania Oncology Hematology Associates Philadelphia, Pennsylvania  19107
Hematology & Oncology Associates of Virginia Richmond, Virginia  23226
Texas Oncology P.A. Dallas, Texas  75230-2503
West Clinic, P.C. Memphis, Tennessee  38117
Comprehensive Cancer Care Specialists of Boca Raton Boca Raton, Florida  33428
Hematology/Oncology Associates Port Saint Lucie, Florida  34952
Raleigh Hematology/Oncology Associates - Wake Practice Raleigh, North Carolina  27609
Tyler Cancer Center Tyler, Texas  75702
Center for Oncology Research and Treatment, Medical City Hospital Dallas, Texas  75230
Memphis Cancer Center Memphis, Tennessee  38119
Office of Barry S. Berman Orlando, Florida  32806
Cancer Care Northwest Spokane, Washington  99202
Center for Hematology-Oncology Boca Raton, Florida  33486
Hematology-Oncology Associates, PA Pensacola, Florida  32501
Erlanger Health Systems Chattanooga, Tennessee  37403
Arkansas Oncology Associates, P.A. Little Rock, Arkansas  72207
Offices of Richard Shapiro, Benjamin Stafford, and Sharon J. Yee Arcadia, California  91007-7678
Medical Oncology Internal Medicine Los Angeles, California  90067
Bay Area Tumor Institute Oakland, California  94609
Medical Oncology Care Associates Orange, California  92668
P.M.K. Medical Group, Inc. Oxnard, California  93030
Florida Community Cancer Center Hudson, Florida  34667
North Florida Hematology & Oncology Associates Jacksonville, Florida  32204
Office of Thomas A. Marsland Orange Park, Florida  32073
Memorial Hospital West Pembroke Pines, Florida  33028
Oncology & Hematology Associates of West Broward Tamarac, Florida  33321
Office of Ron D. Schiff Tampa, Florida  33613
Hematology and Oncology Consultants Titusville, Florida  32796
Dreyer Medical Clinic Aurora, Illinois  60506
Northwestern Medical Faculty Foundation Chicago, Illinois  60611
Oncology and Hematology Associates Greenfield, Indiana  46140
Oncology Associates of Cedar Rapids Cedar Rapids, Iowa  52403
Physicians Office Metairie, Louisiana  70006
Parker Hughes Cancer Center Roseville, Minnesota  55113
Missouri Cancer Care, P.C. St. Charles, Missouri  63301
North Shore Hematology/Oncology Associates, P.C. East Setauket, New York  11733
Capitol District Hematology Oncology Associates, P.C. Latham, New York  12110-0610
Regional Hematology Oncology Associates Durham, North Carolina  27704
Piedmont Hematology-Oncology Associates-Triad Winston-Salem, North Carolina  27103
Dayton Oncology/Hematology P.A. Dayton, Ohio  45439
Naz Medical Center Midwest City, Oklahoma  73310
Cancer Care Associates Tulsa, Oklahoma  74136
Willamette Valley Cancer Center Eugene, Oregon  97401-8122
Oncology/Hematology Associates - Beaver Beaver, Pennsylvania  15009
St. Thomas Medical Center Nashville, Tennessee  37205
Texas Cancer Center Southwest Dallas, Texas  75235
South Texas Regional Cancer Centers - McAllen McAllen, Texas  78503
Texas Oncology - Mesquite Mesqutie, Texas  75150
Baptist Health System Cancer Program San Antonio, Texas  78205
San Antonio Tumor and Blood Clinic San Antonio, Texas  78217
Hematology-Oncology Associates of Frederiksburg, Inc. Fredericksburg, Virginia  22401
Swedish Medical Center Seattle, Washington  98122-4307
Northwest Cancer Specialists Vancouver, Washington  98664
Advanced Health Care Milwaukee, Wisconsin  53209
Ivinson Memorial Hospital Laramie, Wyoming  82070