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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
Not Enrolling
Colorectal Cancer

Thank you

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

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

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:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Richard A. Gams, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Prologue Research International


United States: Federal Government

Study ID:




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



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Albert Einstein Comprehensive Cancer Center Bronx, New York  10461
Robert H. Lurie Comprehensive Cancer Center, Northwestern University Chicago, Illinois  60611
Lombardi Cancer Center Washington, District of Columbia  20007
Huntsman Cancer Institute Salt Lake City, Utah  84112
Halifax Medical Center Daytona Beach, Florida  32114
James Graham Brown Cancer Center Louisville, Kentucky  40202
New York Medical College Valhalla, New York  10595
Cedars-Sinai Medical Center Los Angeles, California  90048
Cancer Center and Beckman Research Institute, City of Hope Duarte, California  91010-3000
University of Rochester Medical Center Rochester, New York  14642
Kaiser Permanente Medical Center - Vallejo Vallejo, California  94589
Lucille Parker Markey Cancer Center, University of Kentucky Lexington, Kentucky  40536-0093
University of New Mexico Cancer Research & Treatment Center Albuquerque, New Mexico  87131
Monmouth Medical Center Long Branch, New Jersey  07740-6395
Florida Hospital Cancer Institute Orlando, Florida  32804
Scott and White Memorial Hospital Temple, Texas  76508
John Muir Medical Center Walnut Creek, California  94598
Lifespan: The Miriam Hospital Providence, Rhode Island  02906
California Cancer Care, Inc. Greenbrae, California  94904-2007
Hematology Oncology Consultants Inc Columbus, Ohio  43235
Comprehensive Cancer Centers of the Desert Palm Springs, California  92262
Kaiser Permanente-Southern California Permanente Medical Group San Diego, California  92120
Jersey Shore Cancer Center Neptune, New Jersey  07753
Interlakes Oncology/Hematology PC Rochester, New York  14623
Rocky Mountain Cancer Center Denver, Colorado  80218
Oncology-Hematology Group of South Florida Miami, Florida  33176
Cancer Care Specialists of Central Illinois, S.C. Decatur, Illinois  62526
Oklahoma Oncology Inc. Tulsa, Oklahoma  74104
Florida Cancer Specialists Fort Myers, Florida  33901
Northwest Medical Specialists, P.C. Arlington Heights, Illinois  60004
Cancer Therapy and Research Center San Antonio, Texas  78229
Northwestern Connecticut Oncology-Hematology Associates Torrington, Connecticut  06790
Medical Oncology and Hematology Associates Des Moines, Iowa  50309
Mercy Cancer Center Mason City, Iowa  50401
Saint Joseph Mercy Hospital Ann Arbor, Michigan  48106
Salem Hospital Regional Cancer Center Salem, Oregon  97309
HemOnCare, P.C. Brooklyn, New York  11235
Mid-Ohio Oncology/Hematology, Inc. Columbus, Ohio  43222
Seattle Cancer Care Alliance Seattle, Washington  98109
Baton Rouge General Medical Center Baton Rouge, Louisiana  70821-2511
Arizona Clinical Research Center Tucson, Arizona  85712
Jackson Oncology Associates, PLLC Jackson, Mississippi  39202
Pennsylvania Oncology Hematology Associates Philadelphia, Pennsylvania  19107
Hematology/Oncology Associates Port Saint Lucie, Florida  34952
Center for Oncology Research and Treatment, Medical City Hospital Dallas, Texas  75230
Center for Hematology-Oncology Boca Raton, Florida  33486
Intermountain Hematology/Oncology Associates, Inc. Salt Lake City, Utah  84124
Memorial Hospital Cancer Center - Chattanooga Chattanooga, Tennessee  37404
Hope Center Terre Haute, Indiana  47809
Dreyer Medical Clinic Aurora, Illinois  60506
North Shore Hematology/Oncology Associates, P.C. East Setauket, New York  11733
Citrus Valley Medical Center Covina, California  91722
Kenmar Research Institute Los Angeles, California  90057
Lake Heart and Cancer Medical Center Leesburg, Florida  34748
Bend Memorial Clinic Bend, Oregon  97701
Arkansas Cancer Clinic, P.A. Pine Bluff, Arkansas  71603
Cancer and Blood Institute Metairie, Louisiana  70006
Saints Memorial Medical Center Lowell, Massachusetts  01852
Medical Oncology Group Gulfport, Mississippi  39501
St. Joseph Oncology, Inc. Saint Joseph, Missouri  64506
Deaconess Billings Clinic Billings, Montana  59107-5100
Central Jersey Oncology Center New 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 Center Malone, New York  12953
New York University Medical Center New York, New York  10016
South Shore Hematology Oncology Associates, P.C. Rockville Centre, New York  11570
Lawrence M. Stallings Medical Practice Wooster, Ohio  44691
Oncology Hematology of Lehigh Valley, P.C. Bethlehem, Pennsylvania  18015
Family Cancer Center Collierville, Tennessee  38017
Baptist Regional Cancer Center Knoxville, Tennessee  37920
West Cancer Clinic Memphis, Tennessee  38120