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Trial record 33 of 159 for:    colon cancer AND Capecitabine AND Fluorouracil

Bevacizumab and Combination Chemotherapy as First-Line Therapy 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: NCT00423696
Recruitment Status : Unknown
Verified September 2011 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : January 18, 2007
Last Update Posted : September 29, 2011
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of colorectal cancer by blocking blood flow to the tumor. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab together with combination chemotherapy may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective when given together with bevacizumab in treating patients with colorectal cancer.

PURPOSE: This randomized phase II trial is studying bevacizumab to compare how well it works when given together with two different combination chemotherapy regimens as first-line therapy in treating patients with metastatic colorectal cancer that cannot be removed by surgery.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Biological: bevacizumab Drug: capecitabine Drug: fluorouracil Drug: irinotecan hydrochloride Drug: leucovorin calcium Procedure: quality-of-life assessment Phase 2

Detailed Description:



  • Compare the progression-free survival at 6 months in patients with unresectable metastatic colorectal cancer treated with first-line therapy comprising bevacizumab and irinotecan hydrochloride, leucovorin calcium, and fluorouracil (FOLFIRI) vs bevacizumab and irinotecan hydrochloride and capecitabine (XELIRI).


  • Compare the toxicities of these regimens in these patients.
  • Compare the objective response rate and duration of response in patients treated with these regimens.
  • Compare the tumor control in patients treated with these regimens.
  • Compare the progression-free and overall survival of patients treated with these regimens.
  • Compare the quality of life of patients treated with these regimens.

OUTLINE: This is an open-label, randomized, multicenter study. Patients are stratified according to participating center, WHO performance status (0 or 1 vs 2), age (< 65 years vs ≥ 65 years), and number of metastatic sites (1 vs ≥ 2). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive bevacizumab IV over 30-90 minutes, irinotecan hydrochloride IV over 90 minutes, and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV continuously over 46 hours on days 1 and 2. Treatment repeats every 2 weeks for 12 courses in the absence of disease progression or unacceptable toxicity. Patients may then continue to receive bevacizumab alone every 2 weeks in the absence of disease progression.
  • Arm II: Patients receive bevacizumab IV over 30-90 minutes and irinotecan hydrochloride IV over 90 minutes on day 1 and oral capecitabine on days 1-14. Treatment repeats every 3 weeks for 8 courses in the absence of disease progression or unacceptable toxicity. Patients may then continue to receive bevacizumab alone every 3 weeks in the absence of disease progression.

Quality of life is assessed periodically.

After completion of study therapy, patients are followed periodically.

PROJECTED ACCRUAL: A total of 144 patients will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 participants
Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Randomized Study of First-Line Therapy Comprising Bevacizumab and Irinotecan Hydrochloride, Leucovorin Calcium, and Fluorouracil (FOLFIRI) Versus Bevacizumab and Irinotecan Hydrochloride and Capecitabine (XELIRI) in Patients With Unresectable Metastatic Colorectal Cancer [ACCORD]
Study Start Date : January 2006

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Progression-free survival at 6 months

Secondary Outcome Measures :
  1. Percentage of objective responses
  2. Percentage of stable disease responses
  3. Duration of objective response and stable disease
  4. Progression-free survival
  5. Overall survival
  6. Toxicities
  7. 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 colorectal cancer

    • Unresectable metastatic disease
  • Measurable disease
  • No CNS metastases


  • WHO performance status 0-2
  • Life expectancy > 3 months
  • Absolute neutrophil count > 1,500/mm³
  • Platelet count > 100,000/mm³
  • Hemoglobin > 9 g/dL (transfusion allowed)
  • INR < 1.5
  • Alkaline phosphatase < 1.5 times upper limit of normal (ULN)
  • Bilirubin < 1.5 times ULN
  • AST and ALT < 2.5 times ULN (5 times ULN if liver metastases are present)
  • Creatinine clearance > 30 mL/min
  • Urine protein < 2+ OR ≤ 1 g/L by 24-hour urine collection
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No contraindications to study therapy
  • No gastrointestinal or duodenal ulcers
  • No AIDS
  • No serious illness, active infection, or other serious condition that would preclude study therapy
  • No coagulation problem
  • No bleeding diathesis
  • No sensitivity to Chinese hamster ovarian cells or other recombinant human antibodies
  • No severe renal insufficiency
  • No uncontrolled hypertension
  • No active or severe cardiovascular conditions, including the following:

    • Cerebrovascular accident
    • Myocardial infarction within the past 6 months
    • New York Heart Association class II-IV cardiac insufficiency
    • Severe cardiac arrhythmia (even if treated)
  • No primitive stenosis or symptomatic peritoneal carcinosis causing a risk of intestinal subocclusion or occlusion
  • No nonhealing wound or fracture
  • No prior thromboembolic disease
  • No other cancer within the past 2 years except for basal cell skin cancer or carcinoma in situ of the uterine cervix
  • No geographical, social, or psychological condition that would preclude study participation


  • No prior chemotherapy for metastatic disease
  • At least 6 months since prior adjuvant chemotherapy (fluorouracil with or without oxaliplatin)

    • No prior adjuvant chemotherapy comprising irinotecan hydrochloride with or without bevacizumab
  • At least 28 days since prior major surgery
  • Prior radiotherapy allowed except to target lesions
  • At least 10 days since prior anticoagulants
  • No concurrent chronic acetylsalicylic acid (at doses > 325 mg/day)
  • No other concurrent investigational therapy
  • 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): NCT00423696

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C.H.U. de Brest
Brest, France, 29200
Centre Regional Francois Baclesse
Caen, France, 14076
Centre de Lutte Contre le Cancer Georges-Francois Leclerc
Dijon, France, 21079
Centre Oscar Lambret
Lille, France, 59020
Polyclinique des Quatre Pavillons
Lormont, France, 33310
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
Marseille, France, 13273
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, France, 34298
Centre Antoine Lacassagne
Nice, France, 06189
Institut Curie Hopital
Paris, France, 75248
Polyclinique Francheville
Perigueux, France, 24004
Institut Jean Godinot
Reims, France, 51056
Centre Eugene Marquis
Rennes, France, 35062
Centre Rene Huguenin
Saint Cloud, France, 92210
Centre Alexis Vautrin
Vandoeuvre-les-Nancy, France, 54511
Institut Gustave Roussy
Villejuif, France, F-94805
Sponsors and Collaborators
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Study Chair: Michel Ducreux, MD, PhD Gustave Roussy, Cancer Campus, Grand Paris

Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00423696     History of Changes
Other Study ID Numbers: CDR0000523435
First Posted: January 18, 2007    Key Record Dates
Last Update Posted: September 29, 2011
Last Verified: September 2011
Keywords provided by National Cancer Institute (NCI):
stage IV colon cancer
stage IV rectal cancer
recurrent colon cancer
recurrent rectal cancer
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Calcium, Dietary
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Calcium-Regulating Hormones and Agents
Bone Density Conservation Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action