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Fluorouracil and Leucovorin With or Without Oxaliplatin in Treating Patients With Recurrent Metastatic Colorectal Cancer

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
FOLFOX regimen
fluorouracil
leucovorin calcium
oxaliplatin
Sponsored by
Prologue Research International
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring stage IV colon cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Arizona Clinical Research Center
  • Arkansas Cancer Clinic, P.A.
  • Citrus Valley Medical Center
  • Cancer Center and Beckman Research Institute, City of Hope
  • California Cancer Care, Inc.
  • Cedars-Sinai Medical Center
  • Kenmar Research Institute
  • Comprehensive Cancer Centers of the Desert
  • Kaiser Permanente-Southern California Permanente Medical Group
  • Kaiser Permanente Medical Center - Vallejo
  • John Muir Medical Center
  • Rocky Mountain Cancer Center
  • Northwestern Connecticut Oncology-Hematology Associates
  • Lombardi Cancer Center
  • Center for Hematology-Oncology
  • Halifax Medical Center
  • Florida Cancer Specialists
  • Hematology/Oncology Associates
  • Lake Heart and Cancer Medical Center
  • Oncology-Hematology Group of South Florida
  • Florida Hospital Cancer Institute
  • Hematology/Oncology Associates
  • Northwest Medical Specialists, P.C.
  • Dreyer Medical Clinic
  • Robert H. Lurie Comprehensive Cancer Center, Northwestern University
  • Cancer Care Specialists of Central Illinois, S.C.
  • Hope Center
  • Medical Oncology and Hematology Associates
  • Mercy Cancer Center
  • Lucille Parker Markey Cancer Center, University of Kentucky
  • James Graham Brown Cancer Center
  • Baton Rouge General Medical Center
  • Cancer and Blood Institute
  • Saints Memorial Medical Center
  • Saint Joseph Mercy Hospital
  • Medical Oncology Group
  • Jackson Oncology Associates, PLLC
  • St. Joseph Oncology, Inc.
  • Deaconess Billings Clinic
  • Monmouth Medical Center
  • Jersey Shore Cancer Center
  • Central Jersey Oncology Center
  • Hematology Associates of New Jersey, P.A.
  • Monmouth Hematology-Oncology Associates, P.A.
  • University of New Mexico Cancer Research & Treatment Center
  • Albert Einstein Comprehensive Cancer Center
  • HemOnCare, P.C.
  • North Shore Hematology/Oncology Associates, P.C.
  • Reddy Cancer Treatment Center
  • New York University Medical Center
  • Memorial Sloan-Kettering Cancer Center
  • Interlakes Oncology/Hematology PC
  • University of Rochester Medical Center
  • South Shore Hematology Oncology Associates, P.C.
  • New York Medical College
  • Mid-Ohio Oncology/Hematology, Inc.
  • Hematology Oncology Consultants Inc
  • Lawrence M. Stallings Medical Practice
  • Oklahoma Oncology Inc.
  • Bend Memorial Clinic
  • Salem Hospital Regional Cancer Center
  • Oncology Hematology of Lehigh Valley, P.C.
  • Pennsylvania Oncology Hematology Associates
  • Lifespan: The Miriam Hospital
  • Memorial Hospital Cancer Center - Chattanooga
  • Family Cancer Center
  • Baptist Regional Cancer Center
  • West Cancer Clinic
  • Center for Oncology Research and Treatment, Medical City Hospital
  • Cancer Therapy and Research Center
  • Scott and White Memorial Hospital
  • Huntsman Cancer Institute
  • Intermountain Hematology/Oncology Associates, Inc.
  • Seattle Cancer Care Alliance

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
May 6, 2001
Last Updated
June 25, 2013
Sponsor
Prologue Research International
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1. Study Identification

Unique Protocol Identification Number
NCT00016198
Brief Title
Fluorouracil and Leucovorin With or Without Oxaliplatin in Treating Patients With Recurrent Metastatic Colorectal Cancer
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2010
Overall Recruitment Status
Completed
Study Start Date
May 2001 (undefined)
Primary Completion Date
April 2003 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Prologue Research International

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Randomized phase II trial to study the effectiveness of combining fluorouracil and leucovorin with or without oxaliplatin in treating patients who have recurrent metastatic colorectal cancer.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
stage IV colon cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
FOLFOX regimen
Intervention Type
Drug
Intervention Name(s)
fluorouracil
Intervention Type
Drug
Intervention Name(s)
leucovorin calcium
Intervention Type
Drug
Intervention Name(s)
oxaliplatin

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard A. Gams, MD
Organizational Affiliation
Prologue Research International
Official's Role
Study Chair
Facility Information:
Facility Name
Arizona Clinical Research Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Arkansas Cancer Clinic, P.A.
City
Pine Bluff
State/Province
Arkansas
ZIP/Postal Code
71603
Country
United States
Facility Name
Citrus Valley Medical Center
City
Covina
State/Province
California
ZIP/Postal Code
92807
Country
United States
Facility Name
Cancer Center and Beckman Research Institute, City of Hope
City
Duarte
State/Province
California
ZIP/Postal Code
91010-3000
Country
United States
Facility Name
California Cancer Care, Inc.
City
Greenbrae
State/Province
California
ZIP/Postal Code
94904
Country
United States
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Kenmar Research Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
Comprehensive Cancer Centers of the Desert
City
Palm Springs
State/Province
California
ZIP/Postal Code
92262
Country
United States
Facility Name
Kaiser Permanente-Southern California Permanente Medical Group
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
Kaiser Permanente Medical Center - Vallejo
City
Vallejo
State/Province
California
ZIP/Postal Code
94589
Country
United States
Facility Name
John Muir Medical Center
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Rocky Mountain Cancer Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Northwestern Connecticut Oncology-Hematology Associates
City
Torrington
State/Province
Connecticut
ZIP/Postal Code
06790
Country
United States
Facility Name
Lombardi Cancer Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Center for Hematology-Oncology
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Halifax Medical Center
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32114
Country
United States
Facility Name
Florida Cancer Specialists
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
Hematology/Oncology Associates
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Lake Heart and Cancer Medical Center
City
Leesburg
State/Province
Florida
ZIP/Postal Code
34748
Country
United States
Facility Name
Oncology-Hematology Group of South Florida
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Florida Hospital Cancer Institute
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
Hematology/Oncology Associates
City
Port Saint Lucie
State/Province
Florida
ZIP/Postal Code
34952
Country
United States
Facility Name
Northwest Medical Specialists, P.C.
City
Arlington Heights
State/Province
Illinois
ZIP/Postal Code
60004
Country
United States
Facility Name
Dreyer Medical Clinic
City
Aurora
State/Province
Illinois
ZIP/Postal Code
60506
Country
United States
Facility Name
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611-3013
Country
United States
Facility Name
Cancer Care Specialists of Central Illinois, S.C.
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Facility Name
Hope Center
City
Terre Haute
State/Province
Indiana
ZIP/Postal Code
47809
Country
United States
Facility Name
Medical Oncology and Hematology Associates
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States
Facility Name
Mercy Cancer Center
City
Mason City
State/Province
Iowa
ZIP/Postal Code
50401
Country
United States
Facility Name
Lucille Parker Markey Cancer Center, University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536-0093
Country
United States
Facility Name
James Graham Brown Cancer Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Baton Rouge General Medical Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70821-2511
Country
United States
Facility Name
Cancer and Blood Institute
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Saints Memorial Medical Center
City
Lowell
State/Province
Massachusetts
ZIP/Postal Code
01852
Country
United States
Facility Name
Saint Joseph Mercy Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Facility Name
Medical Oncology Group
City
Gulfport
State/Province
Mississippi
ZIP/Postal Code
39501
Country
United States
Facility Name
Jackson Oncology Associates, PLLC
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39202
Country
United States
Facility Name
St. Joseph Oncology, Inc.
City
Saint Joseph
State/Province
Missouri
ZIP/Postal Code
64506
Country
United States
Facility Name
Deaconess Billings Clinic
City
Billings
State/Province
Montana
ZIP/Postal Code
59107-5100
Country
United States
Facility Name
Monmouth Medical Center
City
Long Branch
State/Province
New Jersey
ZIP/Postal Code
07740-6395
Country
United States
Facility Name
Jersey Shore Cancer Center
City
Neptune
State/Province
New Jersey
ZIP/Postal Code
07753
Country
United States
Facility Name
Central Jersey Oncology Center
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
Hematology Associates of New Jersey, P.A.
City
Ridgewood
State/Province
New Jersey
ZIP/Postal Code
07450
Country
United States
Facility Name
Monmouth Hematology-Oncology Associates, P.A.
City
West Long Branch
State/Province
New Jersey
ZIP/Postal Code
07764
Country
United States
Facility Name
University of New Mexico Cancer Research & Treatment Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
Albert Einstein Comprehensive Cancer Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
HemOnCare, P.C.
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11235
Country
United States
Facility Name
North Shore Hematology/Oncology Associates, P.C.
City
East Setauket
State/Province
New York
ZIP/Postal Code
11733
Country
United States
Facility Name
Reddy Cancer Treatment Center
City
Malone
State/Province
New York
ZIP/Postal Code
12953
Country
United States
Facility Name
New York University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Interlakes Oncology/Hematology PC
City
Rochester
State/Province
New York
ZIP/Postal Code
14623
Country
United States
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
South Shore Hematology Oncology Associates, P.C.
City
Rockville Centre
State/Province
New York
ZIP/Postal Code
11570
Country
United States
Facility Name
New York Medical College
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Facility Name
Mid-Ohio Oncology/Hematology, Inc.
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Facility Name
Hematology Oncology Consultants Inc
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43235
Country
United States
Facility Name
Lawrence M. Stallings Medical Practice
City
Wooster
State/Province
Ohio
ZIP/Postal Code
44691
Country
United States
Facility Name
Oklahoma Oncology Inc.
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
Bend Memorial Clinic
City
Bend
State/Province
Oregon
ZIP/Postal Code
97701
Country
United States
Facility Name
Salem Hospital Regional Cancer Center
City
Salem
State/Province
Oregon
ZIP/Postal Code
97309-5014
Country
United States
Facility Name
Oncology Hematology of Lehigh Valley, P.C.
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States
Facility Name
Pennsylvania Oncology Hematology Associates
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Lifespan: The Miriam Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Name
Memorial Hospital Cancer Center - Chattanooga
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Family Cancer Center
City
Collierville
State/Province
Tennessee
ZIP/Postal Code
38017
Country
United States
Facility Name
Baptist Regional Cancer Center
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
West Cancer Clinic
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Center for Oncology Research and Treatment, Medical City Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Cancer Therapy and Research Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Scott and White Memorial Hospital
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
Huntsman Cancer Institute
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
Intermountain Hematology/Oncology Associates, Inc.
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
Facility Name
Seattle Cancer Care Alliance
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Fluorouracil and Leucovorin With or Without Oxaliplatin in Treating Patients With Recurrent Metastatic Colorectal Cancer

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