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A Randomized, Multicenter, Phase II Study Of Bolus/Infusion 5-FU/LV (de Gramont Regimen) Versus Oxaliplatin And Bolus/Infusion 5-FU/LV (de Gramont Regimen) As Third-Line Treatment Of Patients With Metastatic Colorectal Carcinoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer

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Trial Information

A Randomized, Multicenter, Phase II Study Of Bolus/Infusion 5-FU/LV (de Gramont Regimen) Versus Oxaliplatin And Bolus/Infusion 5-FU/LV (de Gramont Regimen) As Third-Line Treatment Of Patients With Metastatic Colorectal Carcinoma


OBJECTIVES: I. Compare the overall response rate and overall survival of patients with
recurrent metastatic colorectal adenocarcinoma treated with third-line therapy comprising
fluorouracil and leucovorin calcium with or without oxaliplatin. II. Compare the onset and
duration of complete and partial responses and duration of disease stabilization in patients
treated with these regimens. III. Compare the proportion of patients with stable disease and
proportion of patients with tumor-related symptomatic improvement treated with these
regimens. IV. Compare the time to disease progression and time to tumor-related symptomatic
worsening in patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two
treatment arms. Arm I: Patients receive leucovorin calcium IV over 2 hours and fluorouracil
IV over 2-4 minutes followed by fluorouracil IV continuously over 22 hours on days 1 and 2.
Arm II: Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours,
and fluorouracil IV over 2-4 minutes followed by fluorouracil IV continuously over 22 hours
on day 1. On day 2, patients receive leucovorin calcium and fluorouracil as in arm I.
Treatment in both arms repeats every 2 weeks for at least 1 year in the absence of disease
progression. Patients are followed at day 30 and then for approximately 6 months.

PROJECTED ACCRUAL: A total of 200 patients (100 per treatment arm) will be accrued for this
study.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically or cytologically confirmed adenocarcinoma of the
colon or rectum Metastatic/recurrent disease not amenable to potentially curative therapy
(e.g., inoperable metastatic disease) Documented sequential disease progression (by CT
scan or MRI) after 2 prior chemotherapy regimens for metastatic/recurrent disease At least
1 unidimensionally measurable lesion At least 20 mm by conventional CT scan or MRI OR At
least 10 mm by spiral CT scan Must have received prior fluorouracil (or capecitabine) and
leucovorin calcium with or without irinotecan as first-line therapy and irinotecan with or
without fluorouracil (or capecitabine) and leucovorin calcium as second-line therapy 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) SGOT and SGPT no greater than 2 times ULN (6 times ULN if documented
liver metastases present) Alkaline phosphatase no greater than 2 times ULN (6 times ULN if
documented liver metastases present) Renal: Creatinine no greater than 1.5 times ULN
Cardiovascular: No New York Heart Association class III or IV symptomatic congestive heart
failure No serious cardiac arrhythmia No unstable angina No myocardial infarction within
the past 6 months Pulmonary: No interstitial pneumonia No 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
peripheral neuropathy (absence of deep tendon reflexes as the sole neurologic abnormality
allowed) No diabetes or active infection No known dihydropyrimidine dehydrogenase
deficiency

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior anticancer biologic therapy
Chemotherapy: See Disease Characteristics No prior oxaliplatin No prior adjuvant
irinotecan Prior adjuvant fluorouracil and leucovorin calcium allowed At least 3 weeks
since prior chemotherapy (e.g., second-line irinotecan with or without fluorouracil (or
capecitabine) and leucovorin calcium) for metastatic disease and recovered Endocrine
therapy: Not specified Radiotherapy: At least 3 weeks since prior radiotherapy No prior
radiotherapy to target lesion unless documented progression within the radiation portal
Surgery: See Disease Characteristics At least 4 weeks since prior surgery for primary
tumor or metastases and recovered Other: No prior investigational anticancer drug No other
concurrent investigational agents

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Richard A. Gams, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Prologue Research International

Authority:

United States: Federal Government

Study ID:

PROLOGUE-EFC4760

NCT ID:

NCT00016198

Start Date:

May 2001

Completion Date:

December 2010

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

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Albert Einstein Comprehensive Cancer CenterBronx, New York  10461
Robert H. Lurie Comprehensive Cancer Center, Northwestern UniversityChicago, Illinois  60611
Lombardi Cancer CenterWashington, District of Columbia  20007
Huntsman Cancer InstituteSalt Lake City, Utah  84112
Halifax Medical CenterDaytona Beach, Florida  32114
James Graham Brown Cancer CenterLouisville, Kentucky  40202
New York Medical CollegeValhalla, New York  10595
Cedars-Sinai Medical CenterLos Angeles, California  90048
Cancer Center and Beckman Research Institute, City of HopeDuarte, California  91010-3000
University of Rochester Medical CenterRochester, New York  14642
Kaiser Permanente Medical Center - VallejoVallejo, California  94589
Lucille Parker Markey Cancer Center, University of KentuckyLexington, Kentucky  40536-0093
University of New Mexico Cancer Research & Treatment CenterAlbuquerque, New Mexico  87131
Monmouth Medical CenterLong Branch, New Jersey  07740-6395
Florida Hospital Cancer InstituteOrlando, Florida  32804
Scott and White Memorial HospitalTemple, Texas  76508
John Muir Medical CenterWalnut Creek, California  94598
Lifespan: The Miriam HospitalProvidence, Rhode Island  02906
California Cancer Care, Inc.Greenbrae, California  94904-2007
Hematology Oncology Consultants IncColumbus, Ohio  43235
Comprehensive Cancer Centers of the DesertPalm Springs, California  92262
Kaiser Permanente-Southern California Permanente Medical GroupSan Diego, California  92120
Jersey Shore Cancer CenterNeptune, New Jersey  07753
Interlakes Oncology/Hematology PCRochester, New York  14623
Rocky Mountain Cancer CenterDenver, Colorado  80218
Oncology-Hematology Group of South FloridaMiami, Florida  33176
Cancer Care Specialists of Central Illinois, S.C.Decatur, Illinois  62526
Oklahoma Oncology Inc.Tulsa, Oklahoma  74104
Florida Cancer SpecialistsFort Myers, Florida  33901
Northwest Medical Specialists, P.C.Arlington Heights, Illinois  60004
Cancer Therapy and Research CenterSan Antonio, Texas  78229
Northwestern Connecticut Oncology-Hematology AssociatesTorrington, Connecticut  06790
Medical Oncology and Hematology AssociatesDes Moines, Iowa  50309
Mercy Cancer CenterMason City, Iowa  50401
Saint Joseph Mercy HospitalAnn Arbor, Michigan  48106
Salem Hospital Regional Cancer CenterSalem, Oregon  97309
HemOnCare, P.C.Brooklyn, New York  11235
Mid-Ohio Oncology/Hematology, Inc.Columbus, Ohio  43222
Seattle Cancer Care AllianceSeattle, Washington  98109
Baton Rouge General Medical CenterBaton Rouge, Louisiana  70821-2511
Arizona Clinical Research CenterTucson, Arizona  85712
Jackson Oncology Associates, PLLCJackson, Mississippi  39202
Pennsylvania Oncology Hematology AssociatesPhiladelphia, Pennsylvania  19107
Hematology/Oncology AssociatesPort Saint Lucie, Florida  34952
Center for Oncology Research and Treatment, Medical City HospitalDallas, Texas  75230
Center for Hematology-OncologyBoca Raton, Florida  33486
Intermountain Hematology/Oncology Associates, Inc.Salt Lake City, Utah  84124
Memorial Hospital Cancer Center - ChattanoogaChattanooga, Tennessee  37404
Hope CenterTerre Haute, Indiana  47809
Dreyer Medical ClinicAurora, Illinois  60506
North Shore Hematology/Oncology Associates, P.C.East Setauket, New York  11733
Citrus Valley Medical CenterCovina, California  91722
Kenmar Research InstituteLos Angeles, California  90057
Lake Heart and Cancer Medical CenterLeesburg, Florida  34748
Bend Memorial ClinicBend, Oregon  97701
Arkansas Cancer Clinic, P.A.Pine Bluff, Arkansas  71603
Cancer and Blood InstituteMetairie, Louisiana  70006
Saints Memorial Medical CenterLowell, Massachusetts  01852
Medical Oncology GroupGulfport, Mississippi  39501
St. Joseph Oncology, Inc.Saint Joseph, Missouri  64506
Deaconess Billings ClinicBillings, Montana  59107-5100
Central Jersey Oncology CenterNew Brunswick, New Jersey  08901
Hematology Associates of New Jersey, P.A.Ridgewood, New Jersey  07450
Monmouth Hematology-Oncology Associates, P.A.West Long Branch, New Jersey  07764
Reddy Cancer Treatment CenterMalone, New York  12953
New York University Medical CenterNew York, New York  10016
South Shore Hematology Oncology Associates, P.C.Rockville Centre, New York  11570
Lawrence M. Stallings Medical PracticeWooster, Ohio  44691
Oncology Hematology of Lehigh Valley, P.C.Bethlehem, Pennsylvania  18015
Family Cancer CenterCollierville, Tennessee  38017
Baptist Regional Cancer CenterKnoxville, Tennessee  37920
West Cancer ClinicMemphis, Tennessee  38120