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Comparison of Combination Chemotherapy Regimens in Treating Patients With Metastatic Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT00066274
Recruitment Status : Unknown
Verified May 2005 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : August 7, 2003
Last Update Posted : January 13, 2009
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving the drugs in different combinations may kill more tumor cells.

PURPOSE: This randomized phase II trial is studying combination chemotherapy containing irinotecan and oxaliplatin to see how well it works compared to two standard combination chemotherapy regimens in treating patients with unresectable metastatic colorectal cancer.

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

Detailed Description:


  • Compare the efficacy, in terms of response rate (partial response and complete response), of irinotecan and oxaliplatin vs irinotecan, fluorouracil, and leucovorin calcium vs oxaliplatin, fluorouracil, and leucovorin calcium in patients with metastatic colorectal cancer.
  • Compare the progression-free survival of patients treated with these regimens.
  • Compare the tolerability of these regimens in these patients.
  • Compare the quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 3 treatment arms.

  • Arm I: Patients receive irinotecan IV over 90 minutes and oxaliplatin IV over 2 hours on day 1.
  • Arm II: Patients receive irinotecan IV over 90 minutes and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV over 46 hours on days 1-2.
  • Arm III: Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV over 46 hours on days 1-2.

In all arms, treatment repeats every 2 weeks for 26 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline and then every 3 months for 1 year.

Patients are followed at 2 months.

PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study within 1 year.

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Primary Purpose: Treatment
Official Title: Randomized Phase II Study Evaluating Three Chemotherapies: [Irinotecan + Oxaliplatin (Irinox)], [Irinotecan + LV5FU2] and [Oxaliplatin + LV5FU2] as First Intention Treatment in Subjects With Metastatic Colorectal Cancer
Study Start Date : May 2002

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed colorectal carcinoma

    • Metastatic disease
  • Not amenable to surgery
  • Unidimensionally measurable disease
  • No bone metastases
  • No brain metastases



  • 18 to 75

Performance status

  • WHO 0-2

Life expectancy

  • At least 12 weeks


  • Neutrophil count at least 2,000/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 10 g/dL


  • Bilirubin no greater than 1.25 times upper limit of normal (ULN) (1.5 times ULN if hepatic metastases are present)
  • SGPT and SGOT no greater than 3 times ULN (5 times ULN if hepatic metastases are present)


  • Creatinine no greater than 1.25 times ULN


  • No concurrent cardiac abnormalities that would preclude study therapy


  • No concurrent pulmonary abnormalities that would preclude study therapy


  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No chronic enteropathy
  • No other prior cancer within the past 5 years except carcinoma in situ of the cervix or curatively treated basal cell skin cancer
  • No concurrent severe uncontrolled infection
  • No obstruction or partial obstruction that would interfere with study therapy
  • No psychological, social, familial, or geographical situation that would preclude study participation


Biologic therapy

  • No concurrent anticancer biological response modifiers


  • No prior chemotherapy (except adjuvant chemotherapy completed more than 6 months ago)
  • No prior irinotecan
  • No prior oxaliplatin
  • No other concurrent chemotherapy

Endocrine therapy

  • No concurrent anticancer hormonal therapy


  • At least 4 weeks since prior pelvic radiotherapy
  • No prior abdominopelvic radiotherapy


  • At least 4 weeks since prior surgery
  • No prior extensive intestinal resection (i.e., more than 1 prior hemicolectomy or extensive resection of the small intestines)


  • No other concurrent experimental medication
  • No other concurrent anticancer therapy

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 ClinicalTrials.gov identifier (NCT number): NCT00066274

Centre Hospitalier de L' Agglomeration Montargoise
Amilly, France, 45207
Pole Sante Sarthe et Loir Hopital Pierre Daguet
Angers, France, 49036
Institut Bergonie
Bordeaux, France, 33076
Centre Regional Francois Baclesse
Caen, France, 14076
Clinique Sainte-Marguerite
Hyeres, France, 83400
Centre Hospitalier Departemental
La Roche Sur Yon, France, F-85025
Centre Oscar Lambret
Lille, France, 59020
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, France, 34298
Centre Antoine Lacassagne
Nice, France, 06189
CHR D'Orleans - Hopital de la Source
Orleans, France, 45100
Polyclinique Francheville
Perigueux, France, 24004
Centre Eugene Marquis
Rennes, France, 35062
CHG Roanne
Roanne, France, F-42300
Centre Hospitalier de Rodez
Rodez, France, 12027
Centre Rene Huguenin
Saint Cloud, France, 92210
Centre Hospitalier Regional Metz Thionville
Thionville, France, 57126
Centre Hospitalier General Lucien Hussel
Vienne, France, 38200
Sponsors and Collaborators
Study Chair: Yves Becouarn, MD Institut Bergonié

ClinicalTrials.gov Identifier: NCT00066274     History of Changes
Other Study ID Numbers: CDR0000315384
First Posted: August 7, 2003    Key Record Dates
Last Update Posted: January 13, 2009
Last Verified: May 2005

Keywords provided by National Cancer Institute (NCI):
stage IV colon cancer
stage IV rectal cancer

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
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Protective Agents