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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
N/A
Open (Enrolling)
Both
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:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Mace L. Rothenberg, MD, FACP

Investigator Role:

Study Chair

Investigator Affiliation:

Vanderbilt-Ingram Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000068394

NCT ID:

NCT00008281

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

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
Albert Einstein Comprehensive Cancer CenterBronx, New York  10461
Albert B. Chandler Medical Center, University of KentuckyLexington, Kentucky  40536-0084
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
Cooper Hospital/University Medical CenterCamden, New Jersey  08103
State University of New York Health Sciences Center - Stony BrookStony Brook, New York  11790-7775
Lineberger Comprehensive Cancer Center, UNCChapel Hill, North Carolina  27599-7295
Abington Memorial HospitalAbington, Pennsylvania  19001
Kimmel Cancer Center of Thomas Jefferson University - PhiladelphiaPhiladelphia, Pennsylvania  19107
University of Pennsylvania Cancer CenterPhiladelphia, Pennsylvania  19104
Simmons Cancer Center - DallasDallas, Texas  75235-9154
University of Pittsburgh Cancer InstitutePittsburgh, Pennsylvania  15213
Baptist Regional Cancer Center - KnoxvilleKnoxville, Tennessee  37901
Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838
NYU School of Medicine's Kaplan Comprehensive Cancer CenterNew York, New York  10016
Lombardi Cancer CenterWashington, District of Columbia  20007
Huntsman Cancer InstituteSalt Lake City, Utah  84112
University of Florida Health Science CenterGainesville, Florida  32610-0296
Lutheran General Cancer Care CenterPark Ridge, Illinois  60068
James Graham Brown Cancer CenterLouisville, Kentucky  40202
Veterans Affairs Medical Center - AlbanyAlbany, New York  12208
New York Medical CollegeValhalla, New York  10595
Virginia Mason Medical CenterSeattle, Washington  98111
University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin  53792
Texas Oncology, P.A.Dallas, Texas  75246
University of Kansas Medical CenterKansas City, Kansas  66160-7353
Kaiser Permanente Medical Center - VallejoVallejo, California  94589
Virginia Oncology Associates - Newport NewsNewport News, Virginia  23606
Comprehensive Cancer Institute of HuntsvilleHuntsville, Alabama  35801
Florida Hospital Cancer InstituteOrlando, Florida  32804
Memorial Regional Hospital Comprehensive Cancer CenterHollywood, Florida  33021
California Cancer Care, Inc.Greenbrae, California  94904-2007
Hematology Oncology Consultants IncColumbus, Ohio  43235
Kaiser Permanente-Southern California Permanente Medical GroupSan Diego, California  92120
Columbia Comprehensive Cancer Care ClinicColumbia, Missouri  65201
Interlakes Oncology/Hematology PCRochester, New York  14623
Rocky Mountain Cancer CenterDenver, Colorado  80218
Oncology-Hematology Group of South FloridaMiami, Florida  33176
Louisiana State University School of MedicineNew Orleans, Louisiana  70112-2822
Texas Oncology PA (TOPA) at Baylor-SammonsDallas, Texas  75246
Ocala Oncology CenterOcala, Florida  34474
Cancer Centers of the CarolinasGreenville, South Carolina  29605
Mount Sinai Comprehensive Cancer CenterMiami Beach, Florida  33140
Oncology Center at Providence ParkMobile, Alabama  36608
St. Vincents Comprehensive Cancer CenterNew York, New York  10011
Florida Cancer SpecialistsFort Myers, Florida  33901
Louisiana Oncology AssociatesLafayette, Louisiana  70506
Lone Star OncologyAustin, Texas  78759
Maine Center for Cancer Medicine and Blood DisordersScarborough, Maine  04074
Park Nicollet ClinicSt. Louis Park, Minnesota  55416
Northwestern Connecticut Oncology-Hematology AssociatesTorrington, Connecticut  06790
Hematology Oncology Associates of Illinois-Highland ParkHighland Park, Illinois  60035
Cancer Center of Kansas - WichitaWichita, Kansas  67214
UW Cancer Center Wausau HospitalWausau, Wisconsin  54401
Missouri Cancer AssociatesColumbia, Missouri  65201
Missouri Baptist Cancer CenterSt. Louis, Missouri  63131
Kaiser Permanente - DenverDenver, Colorado  80205
Cancer Care CenterNew Albany, Indiana  47150
Cancer and Blood Institute of the DesertRancho Mirage, California  92270
Midwest Oncology ConsortiumKansas City, Missouri  64111
St. John's Mercy Medical CenterSaint Louis, Missouri  63141
Lakeland Regional Medical CenterLakeland, Florida  33804
Baton Rouge General Medical CenterBaton Rouge, Louisiana  70821-2511
Arizona Clinical Research CenterTucson, Arizona  85712
Pennsylvania Oncology Hematology AssociatesPhiladelphia, Pennsylvania  19107
Hematology & Oncology Associates of VirginiaRichmond, Virginia  23226
Texas Oncology P.A.Dallas, Texas  75230-2503
West Clinic, P.C.Memphis, Tennessee  38117
Comprehensive Cancer Care Specialists of Boca RatonBoca Raton, Florida  33428
Hematology/Oncology AssociatesPort Saint Lucie, Florida  34952
Raleigh Hematology/Oncology Associates - Wake PracticeRaleigh, North Carolina  27609
Tyler Cancer CenterTyler, Texas  75702
Center for Oncology Research and Treatment, Medical City HospitalDallas, Texas  75230
Memphis Cancer CenterMemphis, Tennessee  38119
Office of Barry S. BermanOrlando, Florida  32806
Cancer Care NorthwestSpokane, Washington  99202
Center for Hematology-OncologyBoca Raton, Florida  33486
Hematology-Oncology Associates, PAPensacola, Florida  32501
Erlanger Health SystemsChattanooga, Tennessee  37403
Arkansas Oncology Associates, P.A.Little Rock, Arkansas  72207
Offices of Richard Shapiro, Benjamin Stafford, and Sharon J. YeeArcadia, California  91007-7678
Medical Oncology Internal MedicineLos Angeles, California  90067
Bay Area Tumor InstituteOakland, California  94609
Medical Oncology Care AssociatesOrange, California  92668
P.M.K. Medical Group, Inc.Oxnard, California  93030
Florida Community Cancer CenterHudson, Florida  34667
North Florida Hematology & Oncology AssociatesJacksonville, Florida  32204
Office of Thomas A. MarslandOrange Park, Florida  32073
Memorial Hospital WestPembroke Pines, Florida  33028
Oncology & Hematology Associates of West BrowardTamarac, Florida  33321
Office of Ron D. SchiffTampa, Florida  33613
Hematology and Oncology ConsultantsTitusville, Florida  32796
Dreyer Medical ClinicAurora, Illinois  60506
Northwestern Medical Faculty FoundationChicago, Illinois  60611
Oncology and Hematology AssociatesGreenfield, Indiana  46140
Oncology Associates of Cedar RapidsCedar Rapids, Iowa  52403
Physicians OfficeMetairie, Louisiana  70006
Parker Hughes Cancer CenterRoseville, 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 AssociatesDurham, North Carolina  27704
Piedmont Hematology-Oncology Associates-TriadWinston-Salem, North Carolina  27103
Dayton Oncology/Hematology P.A.Dayton, Ohio  45439
Naz Medical CenterMidwest City, Oklahoma  73310
Cancer Care AssociatesTulsa, Oklahoma  74136
Willamette Valley Cancer CenterEugene, Oregon  97401-8122
Oncology/Hematology Associates - BeaverBeaver, Pennsylvania  15009
St. Thomas Medical CenterNashville, Tennessee  37205
Texas Cancer Center SouthwestDallas, Texas  75235
South Texas Regional Cancer Centers - McAllenMcAllen, Texas  78503
Texas Oncology - MesquiteMesqutie, Texas  75150
Baptist Health System Cancer ProgramSan Antonio, Texas  78205
San Antonio Tumor and Blood ClinicSan Antonio, Texas  78217
Hematology-Oncology Associates of Frederiksburg, Inc.Fredericksburg, Virginia  22401
Swedish Medical CenterSeattle, Washington  98122-4307
Northwest Cancer SpecialistsVancouver, Washington  98664
Advanced Health CareMilwaukee, Wisconsin  53209
Ivinson Memorial HospitalLaramie, Wyoming  82070