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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2007 by Mast Therapeutics, Inc..
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Mast Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT00337389
First received: June 14, 2006
Last updated: November 15, 2007
Last verified: November 2007
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Mast Therapeutics, Inc.:

Primary Outcome Measures:
  • Progression Free Survival

Secondary Outcome Measures:
  • Response Rate
  • Overall Survival
  • Incidence and Severity of Adverse Events

Estimated Enrollment: 1200
Study Start Date: May 2006
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00337389

  Show 47 Study Locations
Sponsors and Collaborators
Mast Therapeutics, Inc.
Investigators
Study Chair: M. Wasif Saif, MD, MBBS Yale University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00337389     History of Changes
Other Study ID Numbers: 510-05
Study First Received: June 14, 2006
Last Updated: November 15, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Mast Therapeutics, Inc.:
Metastatic
Colorectal
Cancer
CoFactor
Stage IV

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Bevacizumab
Fluorouracil
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on September 18, 2014