Bevacizumab and Oxaliplatin Combined With Irinotecan or Leucovorin and Fluorouracil in Treating Patients With Metastatic or Recurrent Colorectal Cancer
Colorectal Cancer
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring recurrent colon cancer, stage IV colon cancer, recurrent rectal cancer, stage IV rectal cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum
Eligibility Criteria
INCLUSION: Metastatic or locally recurrent colorectal adenocarcinoma Measurable disease At least 2 formalin-fixed paraffin embedded core needle biopsies OR fine needle aspirate containing a minimum of 3 clusters of malignant cells and fixed tissue from the previous biopsy If no tissue samples are available the patient must be willing to undergo biopsy of a metastatic site Age 18 and over Eastern Cooperative Oncology Group (ECOG) Performance status 0-2 Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Prothrombin time (PT)/international normalized ratio (INR) ≤ 1.5 unless patient is receiving full-dose anticoagulants AND the following criteria are met: In-range INR (usually between 2 and 3) AND on a stable dose of warfarin or low molecular weight heparin No active bleeding or pathological condition that is associated with a high risk of bleeding Partial thromboplastin time (PTT) < 1.5 times upper limit of normal (ULN) Alanine transaminase (ALT) and aspartate aminotransferase (AST) < 3 times ULN Bilirubin ≤ 1.5 times ULN Creatinine ≤ 1.8 mg/dL Meets 1 of the following criteria: Protein negative on urine dipstick Urine protein/creatinine ratio < 1.0 Less than 2 g protein on 24-hour urine collection Patients with a history of hypertension must meet the following criteria: Blood pressure < 150/90 mm Hg Stable regimen of anti-hypertensive therapy More than 28 days since prior major or open surgery Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after study participation Prior non-colorectal malignancies are allowed provided the following criteria are met: No current clinical evidence of persistent or recurrent disease No active therapy for non-colorectal malignancy, including hormonal therapy EXCLUSION: Pregnant or nursing Arterial thromboembolic events within the past 6 months, including the following: Transient ischemic attack Cerebrovascular accident Unstable angina pectoris Myocardial infarction Symptomatic arrhythmia Symptomatic congestive heart failure Clinically significant peripheral artery disease New York Heart Association class III or IV heart disease Serious nonhealing wound, ulcer, or bone fracture within the past 28 days Significant traumatic injury within the past 28 days Neuropathy ≥ grade 2 Ongoing or active infection Concurrent prophylactic filgrastim (G-CSF) or sargramostim (GM-CSF) Prior chemotherapy for metastatic disease. Adjuvant therapy completed at least 12 months before first evidence of metastasis allowed Cardiovascular, renal, hepatic, or other nonmalignant systemic disease that would preclude study therapy
Sites / Locations
- California Cancer Care, Incorporated - Greenbrae
- Aurora Presbyterian Hospital
- Boulder Community Hospital
- Penrose Cancer Center at Penrose Hospital
- St. Anthony Central Hospital
- Porter Adventist Hospital
- Presbyterian - St. Luke's Medical Center
- St. Joseph Hospital
- Rose Medical Center
- CCOP - Colorado Cancer Research Program
- Swedish Medical Center
- St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
- North Colorado Medical Center
- Littleton Adventist Hospital
- Sky Ridge Medical Center
- Hope Cancer Care Center at Longmont United Hospital
- McKee Medical Center
- Parker Adventist Hospital
- St. Mary - Corwin Regional Medical Center
- North Suburban Medical Center
- Exempla Lutheran Medical Center
- University of Florida Shands Cancer Center
- Winship Cancer Institute of Emory University
- Veterans Affairs Medical Center - Atlanta (Decatur)
- Robert H. Lurie Comprehensive Cancer Center at Northwestern University
- Hematology and Oncology Associates
- Saint Joseph Hospital
- Decatur Memorial Hospital Cancer Care Institute
- Provena St. Mary's Regional Cancer Center - Kankakee
- North Shore Oncology and Hematology Associates, Limited - Libertyville
- Cancer Care and Hematology Specialists of Chicagoland - Niles
- Swedish-American Regional Cancer Center
- Hematology Oncology Associates - Skokie
- Elkhart General Hospital
- Indiana University Melvin and Bren Simon Cancer Center
- Veterans Affairs Medical Center - Indianapolis
- William N. Wishard Memorial Hospital
- Howard Community Hospital
- Center for Cancer Therapy at LaPorte Hospital and Health Services
- Saint Joseph Regional Medical Center
- CCOP - Northern Indiana CR Consortium
- Memorial Hospital of South Bend
- McCreery Cancer Center at Ottumwa Regional
- Siouxland Hematology-Oncology Associates, LLP
- Mercy Medical Center - Sioux City
- St. Luke's Regional Medical Center
- Borgess Medical Center
- West Michigan Cancer Center
- Bronson Methodist Hospital
- Lakeland Regional Cancer Care Center - St. Joseph
- Lakeside Cancer Specialists, PLLC
- MeritCare Bemidji
- Fairview Ridges Hospital
- Mercy and Unity Cancer Center at Mercy Hospital
- Fairview Southdale Hospital
- Mercy and Unity Cancer Center at Unity Hospital
- Hutchinson Area Health Care
- HealthEast Cancer Care at St. John's Hospital
- Minnesota Oncology - Maplewood
- Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
- Hennepin County Medical Center - Minneapolis
- New Ulm Medical Center
- Humphrey Cancer Center at North Memorial Outpatient Center
- CCOP - Metro-Minnesota
- Park Nicollet Cancer Center
- Regions Hospital Cancer Care Center
- United Hospital
- St. Francis Cancer Center at St. Francis Medical Center
- Lakeview Hospital
- Ridgeview Medical Center
- Willmar Cancer Center at Rice Memorial Hospital
- Minnesota Oncology - Woodbury
- Cancer Resource Center - Lincoln
- CCOP - Missouri Valley Cancer Consortium
- Immanuel Medical Center
- Alegant Health Cancer Center at Bergan Mercy Medical Center
- Lakeside Hospital
- Creighton University Medical Center
- Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
- CCOP - MeritCare Hospital
- Roger Maris Cancer Center at MeritCare Hospital
- Adena Regional Medical Center
- Case Comprehensive Cancer Center
- MetroHealth Cancer Care Center at MetroHealth Medical Center
- Riverside Methodist Hospital Cancer Care
- CCOP - Columbus
- Grant Medical Center Cancer Care
- Mount Carmel Health - West Hospital
- Doctors Hospital at Ohio Health
- Grady Memorial Hospital
- Fairfield Medical Center
- St. Rita's Medical Center
- Strecker Cancer Center at Marietta Memorial Hospital
- Knox Community Hospital
- Licking Memorial Cancer Care Program at Licking Memorial Hospital
- Southern Ohio Medical Center Cancer Center
- Community Hospital of Springfield and Clark County
- Genesis - Good Samaritan Hospital
- Natalie Warren Bryant Cancer Center at St. Francis Hospital
- Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
- Bryn Mawr Hospital
- Cancer Center of Paoli Memorial Hospital
- Fox Chase Cancer Center - Philadelphia
- McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
- CCOP - Main Line Health
- Lankenau Cancer Center at Lankenau Hospital
- Avera Cancer Institute
- Sanford Cancer Center at Sanford USD Medical Center
- Erlanger Cancer Center at Erlanger Hospital - Baroness
- CCOP - Scott and White Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Arm A (High TS, IROX/bev)
Arm B (High TS, FOLFOX/bev)
Arm C (Low or intermediate TS, FOLFOX/bev)
Patients with high TS who are randomized to Arm A receive irinotecan and oxaliplatin plus bevacizumab (IROX/bev). The combination regimen is administered by giving bevacizumab IV over 30-90 minutes followed by oxaliplatin IV over 2 hours and irinotecan IV over 90 minutes on days 1 and 15 every 28 days until disease progression or until any criterion specified in protocol is met.
Patients with high TS who are randomized to Arm B receive 5-Fluorouracil, leucovorin, oxaliplatin, and bevacizumab (FOLFOX/bev). The combination regimen is administered by giving bevacizumab and oxaliplatin as in Arm A, leucovorin calcium IV over 2 hours, and fluorouracil IV over 5 minutes and then continuously over 46 hours on days 1 and 15 every 28 days until disease progression or until any criterion specified in protocol is met.
Patients with low or intermediate TS receive 5-Fluorouracil, leucovorin, oxaliplatin, and bevacizumab (FOLFOX/bev) as in Arm B.