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
18 Years
N/A
Both
Colorectal Cancer
Trial Information
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
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Overall Survival up to 2 Years
Outcome Description:
Percentage of patients with overall survival times of up to 2 years
Outcome Time Frame:
2 years
Safety Issue:
No
Principal Investigator
Bach Ardalan, MD
Investigator Role:
Study Chair
Investigator Affiliation:
University of Miami Sylvester Comprehensive Cancer Center
Authority:
United States: Food and Drug Administration
Study ID:
EPROST-20060042
NCT ID:
NCT00449163
Start Date:
March 2006
Completion Date:
March 2010
Related Keywords:
- Colorectal Cancer
- stage IV colon cancer
- stage IV rectal cancer
- adenocarcinoma of the colon
- adenocarcinoma of the rectum
- Colorectal Neoplasms
Name | Location |
|---|---|
| University of Miami Sylvester Comprehensive Cancer Center - Miami | Miami, Florida 33136 |
