Clinical Trial in Patients With Metastatic 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: NCT00235898
Recruitment Status : Completed
First Posted : October 12, 2005
Last Update Posted : August 25, 2008
Information provided by:
Mast Therapeutics, Inc.

October 6, 2005
October 12, 2005
August 25, 2008
May 2005
March 2008   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00235898 on Archive Site
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Clinical Trial in Patients With Metastatic Colorectal Cancer
A Multi-Center, Open Label, Parallel Group, Randomised, Phase IIB Clinical Trial to Evaluate the Safety and Efficacy of CoFactor and 5-FU Versus Leucovorin and 5-FU in Subjects With Metastatic Colorectal Carcinoma
The objective of this trial is to compare efficacy and safety of CoFactor and 5-fluorouracil (5-FU) versus leucovorin and 5-FU in treatment of metastatic colorectal cancer.
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Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Colon Cancer
  • Rectal Cancer
  • Drug: CoFactor
    Other Name: ANX-510
  • Drug: 5-FU
    Other Name: 5-Fluorouracil
  • Drug: Leucovorin
  • Experimental: 1
    CoFactor, 5-FU
    • Drug: CoFactor
    • Drug: 5-FU
  • Active Comparator: 2
    Leucovorin, 5-FU
    • Drug: 5-FU
    • Drug: Leucovorin
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
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March 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Have surgically incurable, confirmed metastatic colon or rectal adenocarcinoma.
  • Be male or non-pregnant, non-lactating female subjects ≥ 18 years of age.
  • If female, and of childbearing potential, agree to use adequate contraception (as deemed by the investigator) throughout their participation in this study and for 30 days after discontinuation of study medication.
  • If, female of childbearing potential, have a negative pregnancy test prior to the start of the study.
  • Have a life expectancy of at least 6 months.
  • Have radiologically or clinically measurable disease for response assessment. Presence of ascites or pleural effusion(s) are not acceptable as single sites of response assessment, but may be present if dimensional or other discrete measurable disease is present for evaluation.
  • Have an ECOG Performance Level of 0-2 (or Karnofsky of 100-70). A lower ECOG or Karnofsky is acceptable only if clearly due to non-oncologic conditions (e.g., prior paraplegia from polio).
  • Have had no prior chemotherapy for established, metastatic disease. (Subjects may have received adjuvant chemotherapy with fluoropyrimidine therapy).
  • Have at least 6 months elapsed since prior adjuvant 5-FU or CPT-11 therapy, or Mitomycin C or nitrosourea therapy.
  • Have had at least an 8 week interval since any prior radiation therapy or 4 weeks since any major surgery.
  • Have recovered from any toxicities resulting from prior therapies (except for alopecia).
  • Adequate renal, bone marrow, liver function defined as serum creatinine less than 1.5 times the upper limit of normal, serum bilirubin less than 2 times the upper limit of normal, ANC greater than 1.5 x 109/L, Platelet count greater than 90 x 109/L, SGOT (AST) and SGPT (ALT) less than 3 times the upper limit of normal.

Exclusion Criteria:

  • Failure by the subject or the subject's legal representative to sign the Informed Consent.
  • An inability to obtain Informed Consent because of psychiatric or complex medical problems.
  • Have concurrent infection including diagnoses of FUO or evidence of possible central line sepsis (subjects must be afebrile at the start of therapy).
  • Have unstable oncologic emergency syndromes: superior vena cava (SVC) syndrome, rising bilirubin needing stent placement, spinal cord compression, progressive brain metastases, active bleeding, hypercalcemia, etc.
  • Have unstable medical conditions such as acute coronary syndrome, cardio-vascular accident within the previous 12 months (such as transient ischemic attacks, accelerated hypertension), etc.
  • Have cerebellar neurologic syndromes such as Parkinson's disease, multiple sclerosis, and amyotonia.
  • Have a known intolerance to fluoropyrimidine (5-FU, Capecitabine, Floxuridine, UFT) therapy (dihydropyrimidine dehydrogenase deficiency).
  • Patients with vomiting, diarrhea, or nausea of grade greater than 1.
  • Received any investigational drug or agent/procedure, i.e. participation in another trial within 4 weeks before beginning treatment with study drug.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
India,   Poland,   Romania,   Serbia,   United Kingdom
Former Serbia and Montenegro
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Joachim Schupp, MD, Adventrx Pharmaceuticals
Mast Therapeutics, Inc.
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Principal Investigator: James Cassidy, MD Beatson Oncology Centre
Mast Therapeutics, Inc.
August 2008

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