Phase III Randomized Study of 5-FU, CoFactor, and Avastin vs. 5-FU, LV and Avastin for First-Line Colorectal Cancer.
A Phase III Multi-Center Randomized Clinical Trial to Evaluate the Safety and Efficacy of CoFactor and 5-Fluorouracil (5-FU) Plus Bevacizumab Versus Leucovorin and 5-FU Plus Bevacizumab as Initial Treatment for Metastatic Colorectal Carcinoma
1 other identifier
interventional
1,200
2 countries
47
Brief Summary
To compare the progression-free survival time (PFS) in patients treated with 5-FU modulated with CoFactor (plus bevacizumab) to 5-FU modulated with leucovorin (plus bevacizumab) in patients with Metastatic Colorectal Cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
47 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2006
CompletedFirst Submitted
Initial submission to the registry
June 14, 2006
CompletedFirst Posted
Study publicly available on registry
June 16, 2006
CompletedNovember 19, 2007
November 1, 2007
June 14, 2006
November 15, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression Free Survival
Secondary Outcomes (3)
Response Rate
Overall Survival
Incidence and Severity of Adverse Events
Study Arms (2)
1
EXPERIMENTALCoFactor, 5-FU, Avastin
2
ACTIVE COMPARATORLeucovorin, 5-FU, Avastin
Interventions
Eligibility Criteria
You may qualify if:
- Greater or equal to 18 years of age.
- Surgically incurable, metastatic disease from proven colon or rectal adenocarcinoma.
- Life expectancy of at least 3 months.
- Histologically confirmed metastatic disease. Histological confirmation may be waived if needle biopsy presents a significant risk to the subject and the clinical setting is clinically consistent with metastasis of colorectal cancer, e.g. surgical findings at laparotomy, or positive PET scan, synchronous histologically confirmed primary tumor with typical metastatic pattern (stage D disease). Waiver can only be granted by the Sponsor, and these cases will be kept to less than 10% of the total study population.
- Measurable disease. At least one unidimensionally measurable lesion with a diameter ≥10 mm using spiral CT scans (use of spiral CT must be documented in medical records and used consistently throughout the study) or ≥20 mm using conventional CT or MRI scans.
- No prior systemic chemotherapy or immunotherapy for metastatic or advanced local disease. However patients may have had radiosensitizing doses of fluoropyrimidines (only 5-FU or capecitabine, with or without leucovorin or levamisole is permitted) if completed 6 months prior to treatment on this protocol. No prior irinotecan or oxaliplatin in combination with radiotherapy is allowed.
- Prior adjuvant therapy is allowed if completed more than 6 months prior to treatment on this protocol. Regimens which included oxaliplatin and irinotecan are allowed.
- ECOG Performance Status is 0-2 or Karnofsky performance level of 100-70.
- Willing and able to provide written informed consent.
You may not qualify if:
- Any prior exposure to bevacizumab.
- A known intolerance to fluoropyrimidine (5-FU, capecitabine, floxuridine, UFT) therapy suggestive of dihydropyrimidine dehydrogenase (DPD) deficiency.
- Use of the following drugs are not permitted on the protocol: sorivudine (or other nucleoside analogue), or Brivudinâ„¢ (or other DPD inhibitor).
- Pregnancy or lactation. Women with a positive (or no) serum or urine pregnancy test within 15 days of Cycle 1 Week 1. Women must have been amenorrheic for at least 12 consecutive months to be considered to lack potential for child bearing.
- If sexually active and of child-bearing potential, failure to agree to use adequate contraception during this study and for 60 days after discontinuation of study medication.
- A concurrent infection, including diagnoses of FUO and evidence of possible central line sepsis (subjects must be afebrile at the start of therapy).
- Any unstable oncologic emergency syndromes: superior vena cava syndrome, rising bilirubin needing stent placement, spinal cord compression, active bleeding, etc.
- History of CNS metastasis, or other brain tumor, or history of stroke.
- Radiation therapy within 6 weeks of Cycle 1 Week 1, or any radiation therapy which encompasses target lesions selected for this study unless those lesions have documented progression of disease.
- Major surgery, open biopsy, or significant traumatic injury within 4 weeks of Cycle 1 Week 1, or anticipated need for major surgical procedure during the course of the study.
- Fine needle aspiration or placement of a central line catheter within 7 days of Cycle 1 Week 1.
- Inadequate bone marrow, liver or kidney function defined as:
- Serum creatinine more than 1.5 times the upper limit of normal,
- Urine protein to creatinine ratio \>1,
- Serum bilirubin \> 2 times the upper limit of normal,
- +12 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (47)
Research Center In
Florence, Alabama, United States
Research Center In
Anaheim, California, United States
Research Center In
Apple Valley, California, United States
Research Center In
Beverly Hills, California, United States
Research Center In
Irvine, California, United States
Research Center In
Mission Hills, California, United States
Research Center In
Poway, California, United States
Research Center In
Rancho Mirage, California, United States
Mercy General Hospital
Sacramento, California, 95819, United States
Research Center In
Sacramento, California, United States
Research Center In
San Diego, California, United States
Research Site In
San Diego, California, United States
Research Center In
Vista, California, United States
Research Center In
Boynton Beach, Florida, United States
Research Center In
Merritt Island, Florida, United States
Research Center In
Port Saint Lucie, Florida, United States
Research Center In
Tarpon Springs, Florida, United States
Research Center In
Gurnee, Illinois, United States
Research Center In
Joliet, Illinois, United States
Research Center In
Skokie, Illinois, United States
Research Center In
Indianapolis, Indiana, United States
Research Center In
Wichita, Kansas, United States
Research Center In
Hazard, Kentucky, United States
Research Center In
Baltimore, Maryland, United States
Research Center In
Flint, Michigan, United States
Research Center In
Free Soil, Michigan, United States
Research Center In
Grand Rapids, Michigan, United States
Research Center In
Port Huron, Michigan, United States
Research Center In
Jackson, Mississippi, United States
Research Center In
Henderson, Nevada, United States
Research Center In
Las Vegas, Nevada, United States
Research Center In
Reno, Nevada, United States
Research Center In
Cherry Hill, New Jersey, United States
Research Center In
Farmington, New Mexico, United States
Research Center In
East Setauket, New York, United States
Research Center In
Greenville, North Carolina, United States
Research Center In
Middletown, Ohio, United States
Research Center In
Cranston, Rhode Island, United States
Research Center In
Charleston, South Carolina, United States
Research Center In
Columbia, South Carolina, United States
Research Center In
Chattanooga, Tennessee, United States
Research Center In
Collierville, Tennessee, United States
Research Center In
Fort Worth, Texas, United States
Research Center In
Ogden, Utah, United States
Research Center In
Lacey, Washington, United States
Research Center In
Walla Walla, Washington, United States
Research Center In
Zrenjanin, Serbia and Montenegro
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
M. Wasif Saif, MD, MBBS
Yale University
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 14, 2006
First Posted
June 16, 2006
Study Start
May 1, 2006
Last Updated
November 19, 2007
Record last verified: 2007-11