Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been terminated.
(Study terminated by University of Miami Institutional Review Board)
Sponsor:
Information provided by (Responsible Party):
University of Miami Sylvester Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00449163
First received: March 15, 2007
Last updated: July 25, 2014
Last verified: August 2013

March 15, 2007
July 25, 2014
March 2006
March 2010   (final data collection date for primary outcome measure)
Overall Survival up to 2 Years [ Time Frame: 2 years ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Median number of months subjects achieved progression-free survival
  • Toxicity [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • 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.

OBJECTIVES:

Primary

  • Determine whether irinotecan hydrochloride, floxuridine, leucovorin calcium, and bevacizumab improves overall survival of patients with stage IV colorectal cancer.

Secondary

  • Estimate response rate (complete response and partial response), time to response, and progression-free survival of patients treated with this regimen.
  • Estimate the resectability rate in patients treated with this regimen.
  • Evaluate the safety and toxicity of this regimen.
  • Assess the quality of life of patients treated with this regimen.

OUTLINE: Patients receive bevacizumab IV over 90 minutes on days 1 and 22 and irinotecan hydrochloride IV over 90 minutes, leucovorin calcium IV over 24 hours, and high-dose floxuridine IV over 24 hours on days 1, 8, 22, and 29. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients are evaluated after completion of every 2 courses of therapy. Patients whose disease is deemed operable at evaluation are referred to surgery.

Patients complete a quality of life assessment at baseline, every 6 weeks during study treatment, and periodically at follow-up.

After completion of study treatment, patients are followed every 3 months for 6 months, every 6 months for 1 year, and then annually thereafter.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.

Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Colorectal Cancer
  • Biological: bevacizumab
  • Drug: floxuridine
  • Drug: irinotecan hydrochloride
  • Drug: leucovorin calcium
  • Procedure: adjuvant therapy
  • Procedure: neoadjuvant therapy
Experimental: Single Arm
Interventions:
  • Biological: bevacizumab
  • Drug: floxuridine
  • Drug: irinotecan hydrochloride
  • Drug: leucovorin calcium
  • Procedure: adjuvant therapy
  • Procedure: neoadjuvant therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
25
March 2010
March 2010   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the colon and/or rectum
  • Stage IV disease
  • Bidimensionally measurable disease
  • CNS metastasis allowed provided radiotherapy has been completed

PATIENT CHARACTERISTICS:

  • ECOG performance status (PS) 0-1 or Karnofsky PS 70-100%
  • Life expectancy ≥ 2 months
  • Absolute neutrophil count > 1,000/mm³
  • Platelet count ≥ 100,000/mm³
  • Creatinine ≤ 1.5 mg/dL
  • Bilirubin ≤ 1.5 mg/dL
  • AST ≤ 3 times upper limit of normal (5 times ULN if liver metastases are present)
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No other malignancy within the past 5 years
  • No active infection
  • No New York Heart Association class II-IV congestive heart failure
  • No serious underlying medical illness
  • No psychiatric condition or associated condition that would preclude study participation
  • No uncontrolled hypertension

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior chemotherapy or radiotherapy for colorectal cancer, except for adjuvant chemotherapy or radiotherapy
  • At least 8 weeks since prior surgery for colorectal cancer and recovered
  • At least 30 days since prior investigational drugs
  • No concurrent radiotherapy, hormonal therapy, or other chemotherapy or immunotherapy
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00449163
UMIAMI-20060042, SCCC-2005145, WIRB-20060252
Yes
University of Miami Sylvester Comprehensive Cancer Center
University of Miami Sylvester Comprehensive Cancer Center
Not Provided
Study Chair: Bach Ardalan, MD University of Miami Sylvester Comprehensive Cancer Center
University of Miami Sylvester Comprehensive Cancer Center
August 2013

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