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Bevacizumab and Capecitabine as First-Line Therapy in Treating Older Patients With Metastatic Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT00107315
Recruitment Status : Terminated (Terminated due to low accrual)
First Posted : April 6, 2005
Results First Posted : July 4, 2014
Last Update Posted : July 4, 2014
Information provided by (Responsible Party):
Roswell Park Cancer Institute

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, such as capecitabine, 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 capecitabine may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving bevacizumab together with capecitabine works as first-line therapy in treating older patients with metastatic colorectal cancer.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Biological: bevacizumab Drug: capecitabine Phase 2

Detailed Description:



  • Determine the time to disease progression in older patients with metastatic colorectal cancer treated with bevacizumab and capecitabine as first-line therapy.


  • Determine the response rate in patients treated with this regimen.
  • Determine the median survival of patients treated with this regimen.
  • Determine the toxic effects of this regimen in these patients.

OUTLINE: This is an open-label study.

Patients receive bevacizumab IV over 30-90 minutes on day 1 and oral capecitabine twice daily on days 1-7. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 13-16 months.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Capecitabine and Bevacizumab in Elderly Patients With Metastatic Colorectal Cancer
Study Start Date : July 2004
Primary Completion Date : June 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Arm 1
Patients receive bevacizumab IV over 30-90 minutes on day 1 and oral capecitabine twice daily on days 1-7
Biological: bevacizumab Drug: capecitabine

Primary Outcome Measures :
  1. Time to Progression [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Response Rate [ Time Frame: 1 year ]
    Overall Response (OR) = CR + PR.

  2. Median Survival [ Time Frame: 1 year ]
  3. Toxicity [ Time Frame: 1 year ]

    Number of participants with an adverse event.

    Please refer to the adverse event reporting for more detail.

Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically* or cytologically* confirmed colorectal cancer

    • Site of primary tumor must have been confirmed by endoscopy, radiography, or surgery
    • Metastatic disease NOTE: *Patients with a history of surgically treated colorectal cancer who subsequently develop recurrent metastatic disease do not require histologic or cytologic confirmation of metastatic disease unless an interval of > 5 years has elapsed between initial primary surgery and the development of metastases
  • Measurable disease

    • At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
  • No known curative therapy exists
  • No history or evidence of CNS disease by physical exam (e.g., primary brain tumor or brain or CNS metastases)



  • 70 and over

Performance status

  • ECOG 0-1

Life expectancy

  • More than 3 months


  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 9 g/dL
  • No bleeding diathesis or coagulopathy


  • Bilirubin normal
  • AST and ALT ≤ 3 times upper limit of normal (ULN)
  • INR < 1.5 (unless on therapeutic anticoagulants)
  • No unstable or uncompensated hepatic disease


  • Creatinine < 1.2 times ULN OR
  • Creatinine clearance > 60 mL/min
  • No unstable or uncompensated renal disease


  • No history of stroke
  • No uncontrolled hypertension (i.e., blood pressure > 150/100 mm Hg on medication)
  • No myocardial infarction within the past year
  • No New York Heart Association class II-IV congestive heart failure
  • No unstable angina
  • No serious cardiac dysrhythmia requiring medication
  • No other clinically significant cardiovascular disease
  • No other unstable or uncompensated cardiac disease


  • No unstable or uncompensated respiratory disease


  • Fertile patients must use effective contraception
  • Able to receive oral medication
  • No known hypersensitivity to fluorouracil or capecitabine
  • No known dihydropyrimidine dehydrogenase deficiency
  • No seizures not controlled by standard medical therapy
  • No serious nonhealing wound, ulcer, or bone fracture
  • No other malignancy within the past 5 years except completely excised nonmelanoma skin cancer (with no evidence of recurrent disease) or carcinoma in situ of the cervix
  • No other severe or uncontrolled systemic disease


Biologic therapy

  • No prior bevacizumab


  • Prior adjuvant fluorouracil and leucovorin calcium allowed provided the last treatment was administered > 6 months before the development of metastatic disease
  • No prior chemotherapy for metastatic colon cancer
  • No prior irinotecan or oxaliplatin

Endocrine therapy

  • Not specified


  • Not specified


  • See Disease Characteristics
  • More than 28 days since prior and no concurrent major surgery
  • More than 28 days since prior open biopsy
  • More than 7 days since prior fine needle aspiration or core biopsy


  • More than 4 weeks since prior and no concurrent participation in another experimental drug study
  • More than 30 days since prior non-approved or investigational drugs

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): NCT00107315

United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Sponsors and Collaborators
Roswell Park Cancer Institute
Principal Investigator: Marwan Fakih, MD Roswell Park Cancer Institute

Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT00107315     History of Changes
Other Study ID Numbers: I 22204
First Posted: April 6, 2005    Key Record Dates
Results First Posted: July 4, 2014
Last Update Posted: July 4, 2014
Last Verified: June 2014

Keywords provided by Roswell Park Cancer Institute:
recurrent colon cancer
stage IV colon cancer
recurrent rectal 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
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action