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Celecoxib, Leucovorin, Fluorouracil, and Oxaliplatin 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: NCT00072553
Recruitment Status : Unknown
Verified May 2007 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : November 5, 2003
Last Update Posted : February 9, 2009
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Drugs used in chemotherapy, such as leucovorin, fluorouracil, and oxaliplatin, use different ways to stop tumor cells from dividing so they stop growing or die. Celecoxib may stop the growth of colorectal cancer by stopping blood flow to the tumor and by blocking the enzymes necessary for tumor cell growth. Combining chemotherapy with celecoxib may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining celecoxib with leucovorin, fluorouracil, and oxaliplatin in treating patients who have metastatic colorectal cancer.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: celecoxib Drug: fluorouracil Drug: leucovorin calcium Drug: oxaliplatin Procedure: adjuvant therapy Procedure: conventional surgery Procedure: neoadjuvant therapy Phase 2

Detailed Description:



  • Determine the response rate in patients with metastatic colorectal cancer treated with celecoxib, leucovorin calcium, fluorouracil, and oxaliplatin.


  • Determine the toxicity of this regimen in these patients.
  • Determine the time of disease control to evaluate progression-free survival in patients treated with this regimen.
  • Determine the salvage surgery rate in patients treated with this regimen.
  • Determine the duration of chemotherapy-free intervals in patients treated with this regimen.
  • Determine the tolerability of this regimen in these patients.
  • Determine the quality of life of patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive FOLFOX7 chemotherapy comprising oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV over 46 hours beginning on day 1. Patients also receive oral celecoxib twice daily beginning on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease stop treatment. If disease progression occurs during the chemotherapy-free interval, patients receive an additional 6 courses.

Patients with responding disease after receiving at least 6 courses of chemotherapy may undergo surgery. Beginning within 10 weeks after surgery, patients receive simplified LV5FU2 chemotherapy comprising leucovorin calcium IV over 2 hours on day 1, fluorouracil IV over 46 hours beginning on day 1, and oral celecoxib twice daily beginning on day 1. Treatment repeats every 14 days for at least 12 courses.

Quality of life is assessed at baseline, during courses 4 and 6, and then every 2 months thereafter.

Patients are followed at 1 month and then every 2 months thereafter.

PROJECTED ACCRUAL: A total of 39 patients will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Of An Optimized LV-5FU-Oxaliplatin Strategy With Celebrex In Metastatic Colorectal Cancer, Optimox2-Celecoxib Study
Study Start Date : September 2003

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Response rate

Secondary Outcome Measures :
  1. Toxicity
  2. Time of disease control (progression-free survival)
  3. Salvage surgery rate
  4. Duration of chemotherapy-free intervals
  5. Tolerability
  6. Quality of life

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 adenocarcinoma of the colon or rectum

    • Metastatic disease
    • Inoperable disease (i.e., not suitable for complete carcinological surgical resection)
  • Measurable disease or nonmeasurable disease

    • At least 1 unidimensionally measurable lesion at least 20 mm by conventional CT scan OR 10 mm by spiral CT scan
    • Nonmeasurable disease defined as all other lesions, including small lesions or truly nonmeasurable disease
  • No CNS metastases
  • No exclusive bone metastases
  • No symptomatic ascites or pleural effusion not evacuated before study entry



  • 18 to 75

Performance status

  • WHO 0-2

Life expectancy

  • Not specified


  • Neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • No known significant bleeding disorder


  • Alkaline phosphatase less than 3 times upper limit of normal (ULN)


  • Creatinine less than 1.5 times ULN OR
  • Creatinine clearance at least 30 mL/min
  • No uncontrolled hypercalcemia


  • No congestive heart failure


  • No total or partial bowel obstruction
  • No active gastric or duodenal ulceration or gastrointestinal bleeding within the past year
  • No active inflammatory bowel disease


  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • HIV negative
  • No peripheral sensory neuropathy
  • No known sensitivity to celecoxib, other COX-2 inhibitors, NSAIDs, salicylates, or sulfonamides
  • No AIDS-related illness
  • No active infection
  • No other malignancy within the past 5 years except adequately treated carcinoma in situ of the cervix or basal cell or squamous cell skin cancer
  • No other severe acute or chronic medical or psychiatric condition or laboratory abnormality that would preclude study participation


Biologic therapy

  • No prior immunotherapy for metastatic disease


  • Prior adjuvant chemotherapy allowed provided the progression-free interval after completion of therapy is more than 6 months in duration
  • No prior chemotherapy for metastatic disease
  • No prior adjuvant oxaliplatin
  • No other concurrent chemotherapy

Endocrine therapy

  • No concurrent chronic oral or IV corticosteroid use (i.e., 2 weeks or longer in duration)


  • No concurrent radiotherapy


  • Not specified


  • More than 30 days since prior investigational drugs
  • No other concurrent investigational drugs or treatments
  • No concurrent prophylactic fluconazole
  • No concurrent chronic full-dose aspirin (at least 325 mg/day), other nonsteroidal anti-inflammatory drugs (NSAIDs), or other cyclooxygenase (COX)-2 inhibitors

    • Concurrent low-dose (cardioprotective) aspirin (80 mg/day or equivalent) allowed
  • No concurrent lithium
  • 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): NCT00072553

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Hopital Tenon
Paris, France, 75970
Sponsors and Collaborators
GERCOR - Multidisciplinary Oncology Cooperative Group
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Study Chair: Thierry Andre, MD GERCOR - Multidisciplinary Oncology Cooperative Group
Publications of Results:
Layout table for additonal information Identifier: NCT00072553    
Other Study ID Numbers: CDR0000340181
First Posted: November 5, 2003    Key Record Dates
Last Update Posted: February 9, 2009
Last Verified: May 2007
Keywords provided by National Cancer Institute (NCI):
stage IV rectal cancer
stage IV colon cancer
adenocarcinoma of the colon
adenocarcinoma of the rectum
recurrent rectal cancer
recurrent colon 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
Protective Agents
Vitamin B Complex