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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.

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.

Condition or disease Intervention/treatment Phase
Metastatic Colorectal Cancer Colon Cancer Rectal Cancer Drug: 5- Fluorouracil (5-FU) Drug: bevacizumab (Avastin) Drug: Leucovorin Drug: CoFactor (ANX-510) Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : May 2006

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Progression Free Survival

Secondary Outcome Measures :
  1. Response Rate
  2. Overall Survival
  3. Incidence and Severity of Adverse Events

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00337389

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Sponsors and Collaborators
Mast Therapeutics, Inc.
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Study Chair: M. Wasif Saif, MD, MBBS Yale University
Layout table for additonal information Identifier: NCT00337389    
Other Study ID Numbers: 510-05
First Posted: June 16, 2006    Key Record Dates
Last Update Posted: November 19, 2007
Last Verified: November 2007
Keywords provided by Mast Therapeutics, Inc.:
Stage IV
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Protective Agents
Vitamin B Complex