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
  Purpose

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.


Condition Intervention Phase
Colorectal Cancer
Biological: bevacizumab
Drug: floxuridine
Drug: irinotecan hydrochloride
Drug: leucovorin calcium
Procedure: adjuvant therapy
Procedure: neoadjuvant therapy
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by University of Miami Sylvester Comprehensive Cancer Center:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 ]

Enrollment: 25
Study Start Date: March 2006
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Arm Biological: bevacizumab Drug: floxuridine Drug: irinotecan hydrochloride Drug: leucovorin calcium Procedure: adjuvant therapy Procedure: neoadjuvant therapy

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00449163

Locations
United States, Florida
University of Miami Sylvester Comprehensive Cancer Center - Miami
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami Sylvester Comprehensive Cancer Center
Investigators
Study Chair: Bach Ardalan, MD University of Miami Sylvester Comprehensive Cancer Center
  More Information

No publications provided

Responsible Party: University of Miami Sylvester Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00449163     History of Changes
Other Study ID Numbers: UMIAMI-20060042, SCCC-2005145, WIRB-20060252
Study First Received: March 15, 2007
Results First Received: January 23, 2013
Last Updated: July 25, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Miami Sylvester Comprehensive Cancer Center:
stage IV colon cancer
stage IV rectal cancer
adenocarcinoma of the colon
adenocarcinoma of the rectum

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Bevacizumab
Irinotecan
Floxuridine
Levoleucovorin
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses
Antineoplastic Agents, Phytogenic
Radiation-Sensitizing Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antidotes

ClinicalTrials.gov processed this record on September 22, 2014