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Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer That Cannot Be Removed By Surgery

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: NCT00274872
Recruitment Status : Unknown
Verified May 2007 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : January 11, 2006
Last Update Posted : February 1, 2010
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, leucovorin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating colorectal cancer.

PURPOSE: This randomized phase II/III trial is studying two combination chemotherapy regimens to compare how well they work in treating patients with metastatic colorectal cancer that cannot be removed by surgery.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: fluorouracil Drug: leucovorin calcium Drug: oxaliplatin Phase 2 Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II-III Study of an Optimized LV-5FU-Oxaliplatin Strategy in Metastatic Colorectal Cancer. Optimox2 Study. C02-2
Study Start Date : January 2004

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Overall survival
  2. Time to disease control
  3. Response as measured by RECIST criteria
  4. Toxicity
  5. Quality of life as assessed by EUROQOL- 5 Dimensional Instrument or Functional Assessment of Cancer Therapy-Neurotoxicity module version 4.0 at baseline and periodically during study treatment
  6. Pharmaco-economic evaluation

Information from the National Library of Medicine

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


  • Histologically proven adenocarcinoma of the colon or rectum

    • Metastatic disease

      • No metastases involving only the bone
  • Inoperable disease (i.e., not suitable for complete surgical resection)
  • Measurable or evaluable disease

    • Measurable disease defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional CT scan OR ≥ 10 mm by spiral CT scan
  • No symptomatic ascites or pleural effusion that has not been evacuated
  • No CNS metastasis


  • WHO OR ECOG performance status 0-2
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelets ≥ 100,000/mm^3
  • Creatinine < 3 times upper limit of normal (ULN)
  • Alkaline phosphatase < 5 times ULN
  • No peripheral neuropathy ≥ grade 1
  • No total or partial bowel obstruction
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No uncontrolled hypercalcemia
  • No other concurrent or prior malignancy, except adequately treated carcinoma in situ of the uterine cervix or basal or squamous cell carcinoma of the skin or cancer in complete remission for ≥ 5 years
  • No uncontrolled congestive heart failure
  • No angina pectoris
  • No hypertension
  • No arrhythmias
  • No history of significant neurologic or psychiatric disorders
  • No active infection
  • No other serious nonmalignant disease


  • No prior chemotherapy and/or immunotherapy for metastatic disease
  • Prior adjuvant chemotherapy allowed provided progression-free interval after completion of adjuvant chemotherapy is > 6 months
  • No other concurrent anticancer treatment
  • No participation in another clinical trial with any investigational drug within 30 days prior to randomization
  • No other concurrent investigational treatment
  • No concurrent radiotherapy
  • No concurrent cold cap for prevention of alopecia or iced mouth rinses for prevention of stomatitis

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): NCT00274872

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Institut Sainte Catherine
Avignon, France, 84082
Hopital Duffaut
Avignon, France, 84902
Infirmerie Protestante
Caluire, France, 69300
Hopital Drevon
Dijon, France, 21000
Centre Hospitalier de Dreux
Dreux, France, 28100
Hopital Louis Pasteur - Le Coudray
Le Coudray, France, 28630
Clinique Victor Hugo
Le Mans, France, F-72000
Hopital Robert Boulin
Libourne, France, 33500
Clinique Saint Jean
Lyon, France, 69008
Intercommunal Hospital
Montfermeil, France, 93370
Hopital Europeen Georges Pompidou
Paris, France, 75015
Hopital Saint Antoine
Paris, France, 75571
Hopital Tenon
Paris, France, 75970
Polyclinique De Courlancy
Reims, France, F-51100
C.H. Senlis
Senlis, France, 60309
Clinique des Jockeys
Senlis, France, 60309
Centre Medico-Chirurgical Foch
Suresnes, France, 92151
Sponsors and Collaborators
GERCOR - Multidisciplinary Oncology Cooperative Group
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Study Chair: Aimery de Gramont, MD Hopital Saint Antoine

Publications of Results:
Layout table for additonal information Identifier: NCT00274872     History of Changes
Other Study ID Numbers: CDR0000453890
First Posted: January 11, 2006    Key Record Dates
Last Update Posted: February 1, 2010
Last Verified: May 2007
Keywords provided by National Cancer Institute (NCI):
recurrent rectal cancer
stage IV rectal cancer
recurrent colon cancer
stage IV colon cancer
adenocarcinoma of the colon
adenocarcinoma of the rectum
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
Physiological Effects of Drugs
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors