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Colorectal Cancer

mFOLFOX6 w/Tivozanib or Bevacizumab for Metastatic Colorectal Cancer
A Phase 2, Open Label, Multicenter, Randomized Trial Comparing Tivozanib in Combination With mFOLFOX6 to Bevacizumab in Combination With mFOLFOX6, In Stage IV Metastatic Colorectal Cancer (mCRC) Subjects
Status Conditions Phase Study ID
Closed Colorectal Cancer Phase II NCT01478594
Summary

The objective of this study is to compare the progression free survival (PFS), overall survival (OS), objective response rate (ORR), time to treatment failure (TTF), duration of response (DoR), quality of life, safety and tolerability of tivozanib in combination with mFOLFOX6 and bevacizumab in combination with mFOLFOX6.


Investigator
William P. Harris, MD
Location    
Seattle Cancer Care Alliance 800-804-8824  
Eligibility Criteria (must meet the following to participate in this study)
  • Documented diagnosis of metastatic colorectal cancer
  • One measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
  • No prior systemic chemotherapy for advanced colorectal cancer; no fluorouracil containing adjuvant therapy in previous 6 months
  • Eastern Cooperative Oncology Group (ECOG) status of 0 or 1
Exclusions (conditions that would prevent participation in this study)
  • Any prior Vascular Endothelial Growth Factor (VEGF)-directed therapy or any other agent or investigational agent targeting the VEGF pathway
  • Primary Central Nervous System (CNS) malignancies or CNS metastases
  • Hematologic abnormalities:
    • Hemoglobin < 9.0 g/dL,
    • ANC < 2000 per mm3,
    • Platelet count < 100,000 per mm3,
    • Prothrombin (PT) or Partial Thromboplastin Time (PTT) > 1.5 X Upper Limit of Normal (ULN)
  • Serum chemistry abnormalities:
    • Total bilirubin > 1.5 X ULN,
    • Aspartate aminotransferase (AST) or Alanine Aminotransferase (ALT) > 2.5 X ULN,
    • Alkaline phosphatase > 2.5 X ULN,
    • Serum albumin < 2.0 g/dL,
    • Creatinine > 1.5 X ULN,
    • Proteinuria > 2+ by urine dipstick
  • Significant cardiovascular disease
  • Significant thromboembolic or vascular disorders within 6 months prior to administration of first dose of study drug
  • Non-healing wound, bone fracture, or skin ulcer
  • Inadequate recovery from any prior surgical procedure or major surgical procedure within 8 weeks prior to administration, or anticipation of major surgical procedure during the course of the study
  • History of significant gastrointestinal (GI) toxicity, diarrhea, or stomatitis within the last 6 weeks
  • An active peptic ulcer disease, inflammatory bowel disease, ulcerative colitis, or other gastrointestinal condition with increased risk of perforation
  • History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 4 weeks prior to administration of first dose of study drug
  • Serious/active infection or infection requiring antibiotics
  • Significant bleeding disorders within 6 months prior to administration of first dose of study drug
  • Active second primary malignancy, other than non-melanoma skin cancers, non-metastatic prostate cancer, in situ cervical cancer and ductal or lobular carcinoma in situ of the breast. Subject is not considered to have a currently active malignancy if they have completed anti-cancer therapy and have been disease free for > 5 years
  • History of allergic reactions, or intolerance, attributed to compounds of similar chemical or biologic composition to 5-fluorouracil, history of Grade 3 hypersensitivity to oxaliplatin, history of allergic reaction to folic acid
  • Female subject is pregnant or lactating
  • Known history of genetic or acquired immune suppression disease including Human Immunodeficiency Virus (HIV); subjects on immune suppressive therapy for organ transplant
  • Inability to swallow pills, malabsorption syndrome or gastrointestinal disease, major resection of the stomach or small bowel, or gastric bypass
  • Uncontrolled neuro-psychiatric disorder or altered mental status
  • Peripheral neuropathy ≥ Grade 2
  • Participating in another interventional protocol
Last Updated
December 03, 2013
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.