Fluorouracil, Leucovorin, and Irinotecan in Treating Patients With Recurrent or Refractory Metastatic Unresectable Colorectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00075595
Recruitment Status : Unknown
Verified August 2007 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : January 12, 2004
Last Update Posted : January 6, 2009
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Drugs used in chemotherapy, such as fluorouracil, leucovorin, and irinotecan, use different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one chemotherapy drug may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving fluorouracil together with leucovorin and irinotecan works in treating patients with recurrent or refractory metastatic unresectable colorectal cancer.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: FOLFIRI regimen Drug: fluorouracil Drug: irinotecan hydrochloride Drug: leucovorin calcium Phase 2

Detailed Description:



  • Determine the time to progression and time to death from progression in patients with recurrent or refractory metastatic unresectable colorectal cancer treated with fluorouracil, leucovorin calcium, and irinotecan.


  • Determine the objective response and stabilization rate in patients treated with this regimen.
  • Determine the time to treatment failure in patients treated with this regimen.
  • Determine the duration of response in patients treated with this regimen.
  • Determine overall survival rate in patients treated with this regimen.
  • Determine the incidence of grade 3 or 4 toxicity in patients treated with this regimen.

OUTLINE: This is an open-label, multicenter study.

Patients receive leucovorin calcium IV over 2 hours on day 1, irinotecan IV over 1 hour on days 1 and 3, and fluorouracil IV continuously over 46 hours beginning on day 1. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 78 patients will be accrued for this study within 18 months.

Study Type : Interventional  (Clinical Trial)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of 5FU/Folinic Acid and Irinotecan as Second or Third Line Treatment in Patients With Metastatic, Unresectable, Colorectal Cancer
Study Start Date : June 2002

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Time to progression
  2. Time to death from progression

Secondary Outcome Measures :
  1. Objective response
  2. Stabilization rate
  3. Time to treatment failure
  4. Duration of response
  5. Overall survival rate
  6. Incidence of grade 3 or 4 toxicity

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed colorectal adenocarcinoma

    • Metastatic, unresectable disease
  • Meets 1 of the following criteria:

    • At least 1 unidimensionally measurable metastatic lesion at least 10 mm by spiral scan OR 20 mm by conventional scan
    • Evaluable disease
    • Evidence of disease (e.g., ascites or bone metastases) by imaging techniques
  • Progressive disease as defined by 1 of the following criteria:

    • Progressive disease while receiving first-line chemotherapy
    • Recurrent disease within 6 months after completing adjuvant chemotherapy
  • No symptomatic brain metastases



  • 18 to 80

Performance status

  • WHO 0-2

Life expectancy

  • At least 3 months


  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3


  • Bilirubin < 1.5 times upper limit of normal (ULN)
  • Alkaline phosphatase < 3 times ULN


  • Not specified


  • No uncontrolled angina
  • No myocardial infarction within the past 6 months


  • No chronic diarrhea grade 2 or greater
  • No unresolved fully or partially obstructed intestine


  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No other underlying disease or medical condition that would preclude study participation
  • No other prior malignancy except curatively treated basal cell cancer or carcinoma in situ of the cervix
  • No psychological, social, familial, or geographical condition that would preclude study follow-up


Biologic therapy

  • Not specified


  • See Disease Characteristics
  • No prior irinotecan

Endocrine therapy

  • Not specified


  • At least 3 weeks since prior radiotherapy


  • At least 3 weeks since prior surgery


  • No other concurrent clinical trial participation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00075595

Hopital Drevon
Dijon, France, 21000
Centre Hospital Universitaire Hop Huriez
Lille, France, 59037
Clinique Saint Jean
Lyon, France, 69008
Hopital Saint Joseph
Marseille, France, 13008
Intercommunal Hospital
Montfermeil, France, 93370
American Hospital of Paris
Neuilly Sur Seine, France, F-92202
Hopital Europeen Georges Pompidou
Paris, France, 75015
Hopital Bichat - Claude Bernard
Paris, France, 75018
Hopital Saint Antoine
Paris, France, 75571
Hopital Tenon
Paris, France, 75970
Clinique Ste - Marie
Pontoise, France, 95300
Polyclinique De Courlancy
Reims, France, F-51100
Clinique Armoricaine De Radiologie
Saint Brieuc, France, F-22015
Clinique de l'Orangerie
Strasbourg, France, 67010
Centre Medico-Chirurgical Foch
Suresnes, France, 92151
Sponsors and Collaborators
GERCOR - Multidisciplinary Oncology Cooperative Group
OverallOfficial: May Mabro, MD Hopital Foch Identifier: NCT00075595     History of Changes
Other Study ID Numbers: CDR0000347378
First Posted: January 12, 2004    Key Record Dates
Last Update Posted: January 6, 2009
Last Verified: August 2007

Keywords provided by National Cancer Institute (NCI):
stage IV colon cancer
stage IV rectal cancer
recurrent colon cancer
recurrent rectal cancer
adenocarcinoma of the colon
adenocarcinoma of the rectum

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Protective Agents