Working… Menu

Bevacizumab and Capecitabine as First-Line Therapy in Treating Older 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: 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

Tracking Information
First Submitted Date  ICMJE April 5, 2005
First Posted Date  ICMJE April 6, 2005
Results First Submitted Date  ICMJE January 8, 2014
Results First Posted Date  ICMJE July 4, 2014
Last Update Posted Date July 4, 2014
Study Start Date  ICMJE July 2004
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 3, 2014)
Time to Progression [ Time Frame: 1 year ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00107315 on Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 3, 2014)
  • Response Rate [ Time Frame: 1 year ]
    Overall Response (OR) = CR + PR.
  • Median Survival [ Time Frame: 1 year ]
  • Toxicity [ Time Frame: 1 year ]
    Number of participants with an adverse event. Please refer to the adverse event reporting for more detail.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Bevacizumab and Capecitabine as First-Line Therapy in Treating Older Patients With Metastatic Colorectal Cancer
Official Title  ICMJE A Phase II Study of Capecitabine and Bevacizumab in Elderly Patients With Metastatic Colorectal Cancer
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.

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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Colorectal Cancer
Intervention  ICMJE
  • Biological: bevacizumab
  • Drug: capecitabine
Study Arms  ICMJE 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: January 31, 2013)
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE


  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 70 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00107315
Other Study ID Numbers  ICMJE I 22204
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Roswell Park Cancer Institute
Study Sponsor  ICMJE Roswell Park Cancer Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Marwan Fakih, MD Roswell Park Cancer Institute
PRS Account Roswell Park Cancer Institute
Verification Date June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP