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Phase III Randomized Study of 5-FU, CoFactor, and Avastin vs. 5-FU, LV and Avastin for First-Line Colorectal Cancer.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00337389
Recruitment Status : Unknown
Verified November 2007 by Mast Therapeutics, Inc..
Recruitment status was:  Active, not recruiting
First Posted : June 16, 2006
Last Update Posted : November 19, 2007
Information provided by:
Mast Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE June 14, 2006
First Posted Date  ICMJE June 16, 2006
Last Update Posted Date November 19, 2007
Study Start Date  ICMJE May 2006
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: June 14, 2006)
Progression Free Survival
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00337389 on Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 14, 2006)
  • Response Rate
  • Overall Survival
  • Incidence and Severity of Adverse Events
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Phase III Randomized Study of 5-FU, CoFactor, and Avastin vs. 5-FU, LV and Avastin for First-Line Colorectal Cancer.
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Metastatic Colorectal Cancer
  • Colon Cancer
  • Rectal Cancer
Intervention  ICMJE
  • Drug: 5- Fluorouracil (5-FU)
  • Drug: bevacizumab (Avastin)
  • Drug: Leucovorin
  • Drug: CoFactor (ANX-510)
Study Arms  ICMJE
  • Experimental: 1
    CoFactor, 5-FU, Avastin
    • Drug: 5- Fluorouracil (5-FU)
    • Drug: bevacizumab (Avastin)
    • Drug: CoFactor (ANX-510)
  • Active Comparator: 2
    Leucovorin, 5-FU, Avastin
    • Drug: 5- Fluorouracil (5-FU)
    • Drug: bevacizumab (Avastin)
    • Drug: Leucovorin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 14, 2006)
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Greater or equal to 18 years of age.
  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:

  1. Any prior exposure to bevacizumab.
  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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Former Serbia and Montenegro,   United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00337389
Other Study ID Numbers  ICMJE 510-05
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Mast Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: M. Wasif Saif, MD, MBBS Yale University
PRS Account Mast Therapeutics, Inc.
Verification Date November 2007

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