A Study Combining mFOLFOX6 With Tivozanib or Bevacizumab in Patients With Metastatic Colorectal Cancer as First Line Therapy

Completed · Phase 2

Conditions studied: Colorectal Cancer

In brief

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.

Key facts

Study ID

NCT01478594

Run by

AVEO Pharmaceuticals, Inc.

People needed

265

Starts

2011-12-01

Expected to finish

2015-01-01

Last updated by the study team

2015-07-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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,
• Absolute neutrophil count (ANC) < 2000 per mm\^3,
• Platelet count < 100,000 per mm\^3,
• 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

Where it is running

• Genesis Cancer Center — Hot Springs, Arizona, United States
• Arizona Clinical Research Center — Tucson, Arizona, United States
• University of California San Diego-Morris Cancer Center — La Jolla, California, United States
• UC Irvine Medical Center, Division of Hematology/Oncology — Orange, California, United States
• Desert Hematology Oncology Medical Group, Inc. — Rancho Mirage, California, United States
• Mountain Blue Cancer Care Center — Golden, Colorado, United States
• University of Florida, Davis Cancer Center (VA) — Gainesville, Florida, United States
• Cleveland Clinic Florida — Weston, Florida, United States
• Queen's Medical Center — Honolulu, Hawaii, United States
• University of Hawaii — Honolulu, Hawaii, United States
• Kaiser Foundation Hospitals — Honolulu, Hawaii, United States
• Northwestern University — Chicago, Illinois, United States
• Illinios Cancer Care — Peoria, Illinois, United States
• Investigative Clinical Research of Indiana, LLC — Indianapolis, Indiana, United States
• Horizon Oncology Research, Inc. — Lafayette, Indiana, United States
• Associates of Oncology Hematology, P.C. — Rockville, Maryland, United States
• University of Michigan Health — Ann Arbor, Michigan, United States
• NYU Cancer Institute — New York, New York, United States
• Alamance Regional Medical Center — Burlington, North Carolina, United States
• Tri Country Hematology / Oncology — Canton, Ohio, United States
• Signal Point Clinical Research Center, LLC — Middletown, Ohio, United States
• Cancer Care Associates — Tulsa, Oklahoma, United States
• Oregon Health and Science University — Portland, Oregon, United States
• Oncology Hematology of Lehigh Valley — Bethlehem, Pennsylvania, United States
• Banner MD Anderson Cancer Research Center — Gilbert, Arizona, United States

Full record on ClinicalTrials.gov

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