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Comparison of Combination Chemotherapy Regimens in Treating Patients With Metastatic 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: 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.

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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

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.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
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 identifier (NCT number): NCT00066274

Show Show 17 study locations
Sponsors and Collaborators
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Study Chair: Yves Becouarn, MD Institut Bergonié
Publications of Results:
Layout table for additonal information Identifier: NCT00066274    
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:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Protective Agents