Bevacizumab, Gemcitabine, and Oxaliplatin in Treating Patients With Metastatic Pancreatic Cancer
Pancreatic Cancer
About this trial
This is an interventional treatment trial for Pancreatic Cancer focused on measuring duct cell adenocarcinoma of the pancreas, recurrent pancreatic cancer, stage IV pancreatic cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed ductal cell or undifferentiated adenocarcinoma of the pancreas Previously untreated metastatic disease No islet cell or acinar cell carcinoma or cystadenocarcinoma No invasion of adjacent organs (i.e., duodenum or stomach) or major blood vessels ( i.e., superior mesenteric artery or celiac artery) No CNS metastasis PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 Life expectancy At least 6 months Hematopoietic Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hemoglobin ≥ 10.0 g/dL No bleeding diathesis or uncontrolled coagulopathy No bleeding events within the past 6 months Hepatic Bilirubin ≤ 2 times upper limit of normal (ULN) (stenting allowed) AST ≤ 5 times ULN No esophageal varices Renal Creatinine ≤ 2 times ULN Proteinuria < 1+ by dipstick or urinalysis OR Protein < 1 g/24-hr urine collection No nephrotic syndrome Cardiovascular No New York Heart Association class II-IV congestive heart failure No symptomatic, unstable angina, or coronary artery disease No uncontrolled cardiac arrhythmias No myocardial infarction within the past 6 months No uncontrolled hypertension No history of cerebrovascular events No clinically significant peripheral arterial disease No other clinically significant cardiac disease Pulmonary No hemoptysis within the past 6 months Immunologic No history of allergy or hypersensitivity to bevacizumab, oxaliplatin, or gemcitabine No hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies No known allergy to other platinum compounds No ongoing or active infection Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 6 months after completion of study treatment No serious, non-healing wound, ulcer, or bone fracture No pre-existing peripheral neuropathy > grade 1 No other malignancy within the past 5 years except basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or prostate cancer with a Gleason score < 7 No psychiatric illness or social situation that would preclude study compliance No other uncontrolled illness No gastrointestinal bleeding within the past 6 months No unresolved physical trauma within the past 4 weeks PRIOR CONCURRENT THERAPY: Biologic therapy More than 4 months since prior immunotherapy or biologic therapy No prior adjuvant bevacizumab No concurrent immunotherapy No concurrent colony-stimulating factors during the first course of study therapy Chemotherapy Recovered from prior chemotherapy More than 4 months since prior adjuvant chemotherapy for completely resected disease At least 4 months since prior chemoradiotherapy for locally advanced disease More than 4 months since prior gemcitabine as a radiosensitizer or as maintenance therapy No prior cytotoxic chemotherapy for metastatic disease No prior adjuvant oxaliplatin No other concurrent chemotherapy Endocrine therapy Not specified Radiotherapy See Chemotherapy More than 4 months since prior radiotherapy No prior radiotherapy to > 25% of bone marrow No prior radiotherapy to sole site of measurable disease unless there is radiologically confirmed progression of the irradiated tumor No concurrent radiotherapy Surgery More than 4 weeks since prior major surgery or trauma and recovered No concurrent surgery Other More than 2 weeks since prior and no concurrent thrombolytic agents Anticoagulation therapy with warfarin or low molecular weight heparin is allowed provided the following criteria are met: At least 2 weeks at a stable dose INR 2-3 No active bleeding or pathologic condition that confers a high risk of bleeding (e.g., tumor involving major vessels or known varices) No recent or concurrent participation in another study of experimental drugs
Sites / Locations
- Mobile Infirmary Medical Center
- Mayo Clinic Scottsdale
- Aurora Presbyterian Hospital
- Boulder Community Hospital
- Penrose Cancer Center at Penrose Hospital
- Porter Adventist Hospital
- Presbyterian - St. Luke's Medical Center
- St. Joseph Hospital
- Rose Medical Center
- CCOP - Colorado Cancer Research Program, Incorporated
- Swedish Medical Center
- Front Range Cancer Specialists
- Sky Ridge Medical Center
- Hope Cancer Care Center at Longmont United Hospital
- St. Mary-Corwin Regional Medical Center
- North Suburban Medical Center
- Mayo Clinic - Jacksonville
- Kapiolani Medical Center at Pali Momi
- Cancer Research Center of Hawaii
- OnCare Hawaii, Incorporated - Lusitana
- Queen's Cancer Institute at Queen's Medical Center
- Straub Clinic and Hospital, Incorporated
- OnCare Hawaii, Incorporated - Kuakini
- St. Francis Medical Center
- Kapiolani Medical Center for Women and Children
- Rush-Copley Cancer Care Center
- St. Joseph Medical Center
- Graham Hospital
- Memorial Hospital
- St. Anthony's Memorial Hospital
- Eureka Community Hospital
- Galesburg Clinic
- Galesburg Cottage Hospital
- Mason District Hospital
- Hopedale Medical Complex
- Joliet Oncology-Hematology Associates, Limited - West
- Kewanee Hospital
- McDonough District Hospital
- Trinity Medical Center - East
- BroMenn Regional Medical Center
- Community Cancer Center
- Community Hospital of Ottawa
- Oncology Hematology Associates of Central Illinois, PC - Ottawa
- Cancer Treatment Center at Pekin Hospital
- Proctor Hospital
- CCOP - Illinois Oncology Research Association
- Oncology Hematology Associates of Central Illinois, PC - Peoria
- Methodist Medical Center of Illinois
- OSF St. Francis Medical Center
- Illinois Valley Community Hospital
- Perry Memorial Hospital
- St. Margaret's Hospital
- Carle Cancer Center at Carle Foundation Hospital
- CCOP - Carle Cancer Center
- Saint Anthony Memorial Health Centers
- McFarland Clinic, P. C.
- St. Luke's Hospital
- Cedar Rapids Oncology Associates
- Mercy Regional Cancer Center at Mercy Medical Center
- Mercy Capitol Hospital
- CCOP - Iowa Oncology Research Association
- John Stoddard Cancer Center at Iowa Methodist Medical Center
- Medical Oncology and Hematology Associates at John Stoddard Cancer Center
- Medical Oncology and Hematology Associates at Mercy Cancer Center
- Mercy Cancer Center at Mercy Medical Center - Des Moines
- John Stoddard Cancer Center at Iowa Lutheran Hospital
- Ottumwa Regional Health Center Cancer Center
- Siouxland Hematology-Oncology Associates, LLP
- Siouxland Regional Cancer Center
- Mercy Medical Center - Sioux City
- St. Luke's Regional Medical Center
- Medical Oncology and Hematology Associates - West Des Moines
- Cancer Center of Kansas, PA - Chanute
- Cancer Center of Kansas, PA - Dodge City
- Cancer Center of Kansas, PA - El Dorado
- Cancer Center of Kansas, PA - Kingman
- Southwest Medical Center
- Cancer Center of Kansas, PA - Newton
- Cancer Center of Kansas, PA - Parsons
- Cancer Center of Kansas, PA - Pratt
- Cancer Center of Kansas, PA - Salina
- Cancer Center of Kansas, PA - Wellington
- Associates in Womens Health, PA - North Review
- Cancer Center of Kansas, PA - Medical Arts Tower
- Cancer Center of Kansas, PA - Wichita
- CCOP - Wichita
- Via Christi Cancer Center at Via Christi Regional Medical Center
- Cancer Center of Kansas, PA - Winfield
- Hickman Cancer Center at Bixby Medical Center
- St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital
- CCOP - Michigan Cancer Research Consortium
- Oakwood Cancer Center at Oakwood Hospital and Medical Center
- Green Bay Oncology, Limited - Escanaba
- Genesys Hurley Cancer Institute
- Hurley Medical Center
- Van Elslander Cancer Center at St. John Hospital and Medical Center
- Green Bay Oncology, Limited - Iron Mountain
- Foote Hospital
- Haematology-Oncology Associates of Ohio and Michigan, P.C.
- Sparrow Regional Cancer Center
- Community Cancer Center of Monroe
- Mercy Memorial Hospital System
- Seton Cancer Institute - Saginaw
- St. John Macomb Hospital
- MeritCare Clinic - Bemidji
- Brainerd Medical Center
- St. Joseph's Medical Center
- 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
- Meeker County Memorial Hospital
- HealthEast Cancer Care at St. John's Hospital
- Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
- Hennepin County Medical Center - Minneapolis
- Chippewa County - Montevideo Hospital
- Hubert H. Humphrey Cancer Center at North Memorial Medical Center
- Mayo Clinic Cancer Center
- Coborn Cancer Center
- CCOP - Metro-Minnesota
- Adult and Pediatric Urology, P.L.L.P.
- Saint Francis Cancer Center
- St. Joseph's Hospital
- CentraCare Clinic - River Campus
- Park Nicollet Health Services
- Regions Hospital Cancer Care Center
- United Hospital
- Ridgeview Medical Center
- Woodwinds Health Campus
- CCOP - Montana Cancer Consortium
- Hematology-Oncology Centers of the Northern Rockies - Billings
- Northern Rockies Radiation Oncology Center
- St. Vincent Healthcare
- Deaconess Billings Clinic Cancer Center
- Deaconess Billings Clinic - Downtown
- Bozeman Deaconess Hospital
- St. James Community Hospital
- St. Peter's Hospital
- Glacier Oncology, PLLC
- Kalispell Medical Oncology
- Kalispell Regional Medical Center
- Community Medical Center
- Montana Cancer Specialists at Montana Cancer Center
- Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
- Bryan LGH Medical Center - West
- Cancer Resource Center - Lincoln
- St. Elizabeth Regional Medical Center
- Rutherford Hospital
- Bismarck Cancer Center
- Cancer Care Center at Medcenter One Hospital
- Mid Dakota Clinic, P. C.
- St. Alexius Medical Center
- CCOP - MeritCare Hospital
- MeritCare Medical Group
- Altru Cancer Center at Altru Hospital
- Wood County Oncology Center
- Blanchard Valley Medical Associates
- Fremont Memorial Hospital
- Kenton Oncology, Incorporated
- Lima Memorial Hospital
- Northwest Ohio Oncology Center
- St. Luke's Hospital
- St. Charles Mercy Hospital
- Toledo Clinic - Oregon
- Firelands Regional Medical Center
- North Coast Cancer Care, Incorporated
- Promedica Cancer Center at Flower Hospital
- Mercy Hospital of Tiffin
- Toledo Hospital
- St. Vincent Mercy Medical Center
- Medical University of Ohio Cancer Center
- CCOP - Toledo Community Hospital
- Toledo Clinic, Incorporated - Main Clinic
- Toledo Surgical Specialists
- Fulton County Health Center
- Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
- Geisinger Medical Center
- Allegheny Cancer Center at Allegheny General Hospital
- Geisinger Medical Group - Scenery Park
- Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
- AnMed Health Cancer Center
- CCOP - Upstate Carolina
- Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
- Rapid City Regional Hospital
- Avera Cancer Institute
- Medical X-Ray Center, PC
- Sioux Valley Hospital and University of South Dakota Medical Center
- Green Bay Oncology, Limited at St. Vincent Hospital
- Green Bay Oncology, Limited at St. Mary's Hospital
- St. Mary's Hospital Medical Center - Green Bay
- St. Vincent Hospital Regional Cancer Center
- Franciscan Skemp Healthcare
- Bay Area Cancer Care Center at Bay Area Medical Center
- Green Bay Oncology, Limited - Oconto Falls
- Green Bay Oncology, Limited - Sturgeon Bay
- Welch Cancer Center at Sheridan Memorial Hospital
Arms of the Study
Arm 1
Experimental
gemcitabine + bevacizumab + oxaliplatin
Patients receive gemcitabine IV over 100 minutes and bevacizumab IV over 30-90 minutes on days 1 and 15. Patients also receive oxaliplatin IV over 120 minutes on days 2 and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 2 courses of therapy beyond CR. After completion of study treatment, patients are followed every 3-6 months for up to 5 years.