Phase III Randomized Study of 5-FU, CoFactor, and Avastin vs. 5-FU, LV and Avastin for First-Line Colorectal Cancer.
NCT ID: NCT00337389
Last Updated: 2007-11-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE3
1200 participants
INTERVENTIONAL
2006-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
CoFactor, 5-FU, Avastin
5- Fluorouracil (5-FU)
bevacizumab (Avastin)
CoFactor (ANX-510)
2
Leucovorin, 5-FU, Avastin
5- Fluorouracil (5-FU)
bevacizumab (Avastin)
Leucovorin
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
5- Fluorouracil (5-FU)
bevacizumab (Avastin)
Leucovorin
CoFactor (ANX-510)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Surgically incurable, metastatic disease from proven colon or rectal adenocarcinoma.
3. Life expectancy of at least 3 months.
4. 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.
5. 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.
6. 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.
7. 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.
8. ECOG Performance Status is 0-2 or Karnofsky performance level of 100-70.
9. Willing and able to provide written informed consent.
Exclusion Criteria
2. A known intolerance to fluoropyrimidine (5-FU, capecitabine, floxuridine, UFT) therapy suggestive of dihydropyrimidine dehydrogenase (DPD) deficiency.
3. Use of the following drugs are not permitted on the protocol: sorivudine (or other nucleoside analogue), or Brivudin™ (or other DPD inhibitor).
4. 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.
5. 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.
6. A concurrent infection, including diagnoses of FUO and evidence of possible central line sepsis (subjects must be afebrile at the start of therapy).
7. Any unstable oncologic emergency syndromes: superior vena cava syndrome, rising bilirubin needing stent placement, spinal cord compression, active bleeding, etc.
8. History of CNS metastasis, or other brain tumor, or history of stroke.
9. 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.
10. 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.
11. Fine needle aspiration or placement of a central line catheter within 7 days of Cycle 1 Week 1.
12. 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,
* ANC \< 1.5 x 109/L,
* Hemoglobin \< 9.0 g / dL
* Platelet count \< 90 x 109/L,
* SGOT (AST) and SGPT (ALT) more than 3 times the upper limit of normal, or more than 5 times the upper limit of normal for subjects with documented liver metastases.
13. Myocardial infarction, transient ischemic attack, cerebral bleeding, translumenal cardiac angiography or cardiac stent placement or other arterial thrombotic event within 12 months prior to Cycle 1 Week 1.
14. Active, clinically significant cardiovascular or symptomatic arterial peripheral vascular disease \[e.g., uncontrolled hypertension, congestive heart failure, claudication, unstable angina, symptomatic cardiac arrhythmia, or New York Heart Association (NYHA) Class 2 or greater\].
15. Presence of serious non-healing wounds, gastro-duodenal ulcers active by endoscopy, gastro-intestinal perforation or intra-abdominal abscess, skin ulcers, or bone fractures.
16. INR \>1.5 unless on therapeutic doses of oral anticoagulants (e.g. warfarin). If so, must have an in-range INR (usually between 2-3) on a stable dose of drug.
17. Participation in another experimental drug study within 4 weeks prior to Cycle 1 Week 1.
18. Known or suspected anaphylaxis reaction to leucovorin or any allergic reaction to a drug which, in the opinion of the Investigator, suggests an increased potential for a hypersensitivity to CoFactor or other study drug including excipients.
19. Presence of organ allograft requiring immunosuppressive therapy.
20. Unwilling or unable to comply with the study protocol or history of psychiatric disability judged by the investigator to preclude granting of informed consent.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Mast Therapeutics, Inc.
INDUSTRY
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
M. Wasif Saif, MD, MBBS
Role: STUDY_CHAIR
Yale University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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, 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
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
510-05
Identifier Type: -
Identifier Source: org_study_id