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Combination Chemotherapy and Bevacizumab in Treating Patients With Stage IV Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT00449163
Recruitment Status : Terminated (Study terminated by University of Miami Institutional Review Board)
First Posted : March 19, 2007
Results First Posted : February 28, 2013
Last Update Posted : May 11, 2017
Information provided by (Responsible Party):
University of Miami

March 15, 2007
March 19, 2007
January 23, 2013
February 28, 2013
May 11, 2017
March 1, 2006
March 2010   (Final data collection date for primary outcome measure)
Overall Survival up to 2 Years [ Time Frame: 2 years ]
Percentage of patients with overall survival times of up to 2 years
Overall Survival
Complete list of historical versions of study NCT00449163 on ClinicalTrials.gov Archive Site
  • Response Rate (Complete Response and Partial Response) [ Time Frame: 2 years ]
    Percentage of patients achieving complete response or partial response per RECIST criteria ver 1.0
  • Median Progression-free Survival in Months [ Time Frame: 2 years ]
    Median number of months subjects achieved progression-free survival
  • Rate of Toxicity in Study Participants [ Time Frame: 2 years ]
    Evaluation the safety and toxicities of protocol regimen as evidenced by the rate of serious adverse events in study participants.
  • Response Rate (Complete Response and Partial Response)
  • Progression-free Survival
  • Resectability rate
  • Toxicity
  • Quality of life
Not Provided
Not Provided
Combination Chemotherapy and Bevacizumab in Treating Patients With Stage IV Colorectal Cancer
Phase II Study of Avastin, Irinotecan, High Dose 24 Hour Continuous Intravenous Infusion of Floxuridine and Leucovorin in Patients With Previously Untreated Metastatic Colorectal Cancer

RATIONALE: Drugs used in chemotherapy, such as irinotecan, floxuridine, and leucovorin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. 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. Giving combination chemotherapy together with bevacizumab may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with bevacizumab works in treating patients with stage IV colorectal cancer.

For the purpose of this study treatment cycle consist of six weeks, 2 weeks of consecutive treatment followed by 1 week of rest and 2 weeks of treatment followed by one week of rest. Treatment will be administered weekly, 4 out 6 weeks, on days 1, 8, 22 and 29 according to the schedule. There will be no treatment delivered on weeks 3 & 6 (Days 15 and 36).

Disease will be evaluated by CT scan at the completion of every two cycles. Patients with complete response (CR), or partial response (PR), will be evaluated for possible surgical resection. Patients who become operable will continue to be evaluated for survival and disease relapse. Patients with stable disease (SD), and those with less than pCR after surgery should continue chemotherapy until radiographic evidence of tumor progression is identified or unacceptable side effects.

Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Colorectal Cancer
  • Biological: Bevacizumab
    Other Name: Avastin
  • Drug: Floxuridine
    Other Name: 5-fluorodeoxyuridine
  • Drug: Irinotecan
    Other Names:
    • Irinotecan Hydrochloride
    • Camptosar
  • Drug: Leucovorin
    Other Name: Leucovorin calcium
Experimental: Combination Chemotherapy and Bevacizumab

Treatment cycle is 6 weeks, 2 weeks of consecutive treatment followed by 1 week of rest and 2 weeks of treatment followed by one week of rest. Treatment will be administered weekly, 4 out 6 weeks, on days 1, 8, 22 and 29:

  • Bevacizumab: 7.5mg/kg via intravenous (IV) infusion on Days 1 and 22;
  • Irinotecan: 110 mg/m^2 via IV infusion on Days 1, 8, 22, 29;
  • Leucovorin: 500 mg/m^2 via IV infusion on Days 1, 8, 22 and 29;
  • Floxuridine: 120 mg/kg over continuous infusion on Days 1, 8, 22 and 29.
  • Biological: Bevacizumab
  • Drug: Floxuridine
  • Drug: Irinotecan
  • Drug: Leucovorin
Phase II study of bevacizumab (B), camptosar (I), high-dose 24-hour continuous intravenous infusion of floxuridine (F) and leucovorin (L) in patients with previously untreated metastatic colon cancer. (B-IFL) B. Ardalan, M. Feagans, D. Mezentsev, C. Jones, P. R. Subbarayan, G. Walker, M. Sapp, K. Stephenson, J. Ness, D. Franceschi, and A. Livingstone Journal of Clinical Oncology 2009 27:15S, e15114-e15114

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
March 2010
March 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Patients must have stage IV, histologically confirmed diagnosis of Adenocarcinoma of the colon.
  2. Patients must have bi-dimensionally measurable disease since the purpose of this study is to determine efficacy of treatment.
  3. Patients must be previously untreated.
  4. Patients must be over the age of 18 years.
  5. Patients may not be pregnant. Patients of childbearing years must be using contraception.
  6. Patients must have ECOG performance status of 0-1 or KPS of at least 70.
  7. Patients must have life expectancy of ≥ two months.
  8. Patients must have a white blood cell count of ≥1000/mm³ ANC > 1.0, platelets > 100,000/mm³.
  9. Patients must have adequate renal function as documented by a serum creatinine of ≤ 1.5 mg/dl.
  10. Patients must have a bilirubin of ≤ 1.5 mg/dl and an SGOT of ≤ three times normal for patients with no liver disease, and ≤ five times normal for those with liver metastases.
  11. Patients must be informed of the investigational nature of the study and give written informed consent.
  12. Patients must have indwelling central venous catheter or good peripheral intravenous catheter, preferably a port-a-cath.
  13. Patients may have had prior surgery for their colorectal cancer. Patients must be at least 8 weeks beyond surgery and recovered from all effects of surgery.
  14. Patients enrolled in this study may have a history of prior malignancy (5 years ago) provided that the patient is currently disease-free.

Exclusion Criteria:

  1. Patients who have had prior chemotherapy or radiation therapy for their colorectal cancer, with exception of adjuvant chemo/radiation therapy.
  2. Patients receiving concomitant radiation, hormonal therapy, chemotherapy, or immunotherapy.
  3. Patients receiving any investigational drug within 30 days prior to start of this study.
  4. Patients with serious underlying medical illnesses (including Congestive Heart Failure New York Heart Association Functional Classification 2-4) or active infection.
  5. Patients with central nervous system metastasis must have completed radiation prior to entry into this protocol.
  6. Patients with psychiatric conditions or associated conditions which would make participating in this study dangerous to their health.
  7. Patients with uncontrolled hypertension.
Sexes Eligible for Study: All
18 Years to 120 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
SCCC-2005145 ( Other Identifier: University of Miami Sylvester Comprehensive Cancer Center )
WIRB-20060252 ( Other Identifier: Western Institutional Review Board )
Not Provided
Not Provided
University of Miami
University of Miami
Not Provided
Principal Investigator: Bach Ardalan, MD University of Miami
University of Miami
April 2017

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