Bevacizumab, Gemcitabine, and Oxaliplatin in Treating Patients With Metastatic Pancreatic Cancer
- Conditions
- Pancreatic Cancer
- Interventions
- Registration Number
- NCT00112528
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief Summary
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of pancreatic cancer by blocking blood flow to the tumor. Drugs used in chemotherapy, such as gemcitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab together with gemcitabine and oxaliplatin may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving bevacizumab together with gemcitabine and oxaliplatin works in treating patients with metastatic pancreatic cancer.
- Detailed Description
OBJECTIVES:
Primary
* Determine the 6-month survival of patients with metastatic adenocarcinoma of the pancreas treated with bevacizumab, gemcitabine, and oxaliplatin.
Secondary
* Determine the objective response rate in patients with measurable disease treated with this regimen.
* Determine median survival, progression-free survival, time to treatment failure, and overall survival of patients treated with this regimen.
* Determine the toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study.
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 53
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description gemcitabine + bevacizumab + oxaliplatin bevacizumab 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. gemcitabine + bevacizumab + oxaliplatin gemcitabine hydrochloride 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. gemcitabine + bevacizumab + oxaliplatin 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.
- Primary Outcome Measures
Name Time Method Survival at 6 months at 6 months
- Secondary Outcome Measures
Name Time Method Objective response rate as measured by RECIST criteria Up to 5 years Median survival Up to 5 years Progression-free survival Up to 5 years Time to treatment failure Up to 5 years Overall survival Up to 5 years
Trial Locations
- Locations (196)
Kapiolani Medical Center at Pali Momi
🇺🇸Aiea, Hawaii, United States
St. Mary-Corwin Regional Medical Center
🇺🇸Pueblo, Colorado, United States
Mayo Clinic - Jacksonville
🇺🇸Jacksonville, Florida, United States
Sky Ridge Medical Center
🇺🇸Lone Tree, Colorado, United States
Memorial Hospital
🇺🇸Carthage, Illinois, United States
Rush-Copley Cancer Care Center
🇺🇸Aurora, Illinois, United States
Trinity Medical Center - East
🇺🇸Moline, Illinois, United States
Eureka Community Hospital
🇺🇸Eureka, Illinois, United States
Hopedale Medical Complex
🇺🇸Hopedale, Illinois, United States
Siouxland Hematology-Oncology Associates, LLP
🇺🇸Sioux City, Iowa, United States
St. Anthony's Memorial Hospital
🇺🇸Effingham, Illinois, United States
Community Hospital of Ottawa
🇺🇸Ottawa, Illinois, United States
Cancer Center of Kansas, PA - El Dorado
🇺🇸El Dorado, Kansas, United States
Cancer Center of Kansas, PA - Kingman
🇺🇸Kingman, Kansas, United States
Cancer Center of Kansas, PA - Winfield
🇺🇸Winfield, Kansas, United States
Kewanee Hospital
🇺🇸Kewanee, Illinois, United States
Illinois Valley Community Hospital
🇺🇸Peru, Illinois, United States
Ottumwa Regional Health Center Cancer Center
🇺🇸Ottumwa, Iowa, United States
Galesburg Cottage Hospital
🇺🇸Galesburg, Illinois, United States
St. Margaret's Hospital
🇺🇸Spring Valley, Illinois, United States
Proctor Hospital
🇺🇸Peoria, Illinois, United States
St. Joseph Medical Center
🇺🇸Bloomington, Illinois, United States
BroMenn Regional Medical Center
🇺🇸Normal, Illinois, United States
CCOP - Carle Cancer Center
🇺🇸Urbana, Illinois, United States
Cancer Center of Kansas, PA - Wellington
🇺🇸Wellington, Kansas, United States
Mercy Regional Cancer Center at Mercy Medical Center
🇺🇸Cedar Rapids, Iowa, United States
Cancer Center of Kansas, PA - Medical Arts Tower
🇺🇸Wichita, Kansas, United States
Southwest Medical Center
🇺🇸Liberal, Kansas, United States
OSF St. Francis Medical Center
🇺🇸Peoria, Illinois, United States
Cancer Center of Kansas, PA - Wichita
🇺🇸Wichita, Kansas, United States
McFarland Clinic, P. C.
🇺🇸Ames, Iowa, United States
CCOP - Wichita
🇺🇸Wichita, Kansas, United States
Cancer Treatment Center at Pekin Hospital
🇺🇸Pekin, Illinois, United States
Cancer Center of Kansas, PA - Dodge City
🇺🇸Dodge City, Kansas, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center
🇺🇸Grosse Pointe Woods, Michigan, United States
Fairview Ridges Hospital
🇺🇸Burnsville, Minnesota, United States
Cancer Center of Kansas, PA - Chanute
🇺🇸Chanute, Kansas, United States
Hickman Cancer Center at Bixby Medical Center
🇺🇸Adrian, Michigan, United States
Genesys Hurley Cancer Institute
🇺🇸Flint, Michigan, United States
HealthEast Cancer Care at St. John's Hospital
🇺🇸Maplewood, Minnesota, United States
Toledo Clinic - Oregon
🇺🇸Oregon, Ohio, United States
Medical University of Ohio Cancer Center
🇺🇸Toledo, Ohio, United States
St. Joseph's Medical Center
🇺🇸Brainerd, Minnesota, United States
Sioux Valley Hospital and University of South Dakota Medical Center
🇺🇸Sioux Falls, South Dakota, United States
St. John Macomb Hospital
🇺🇸Warren, Michigan, United States
Mid Dakota Clinic, P. C.
🇺🇸Bismarck, North Dakota, United States
CCOP - Montana Cancer Consortium
🇺🇸Billings, Montana, United States
Rapid City Regional Hospital
🇺🇸Rapid City, South Dakota, United States
Adult and Pediatric Urology, P.L.L.P.
🇺🇸Sartell, Minnesota, United States
Toledo Clinic, Incorporated - Main Clinic
🇺🇸Toledo, Ohio, United States
Seton Cancer Institute - Saginaw
🇺🇸Saginaw, Michigan, United States
CCOP - MeritCare Hospital
🇺🇸Fargo, North Dakota, United States
Mercy Memorial Hospital System
🇺🇸Monroe, Michigan, United States
St. Joseph's Hospital
🇺🇸St Paul, Minnesota, United States
Park Nicollet Health Services
🇺🇸St. Louis Park, Minnesota, United States
Blanchard Valley Medical Associates
🇺🇸Findlay, Ohio, United States
St. Elizabeth Regional Medical Center
🇺🇸Lincoln, Nebraska, United States
MeritCare Clinic - Bemidji
🇺🇸Bemidji, Minnesota, United States
Lima Memorial Hospital
🇺🇸Lima, Ohio, United States
Green Bay Oncology, Limited - Iron Mountain
🇺🇸Iron Mountain, Michigan, United States
Glacier Oncology, PLLC
🇺🇸Kalispell, Montana, United States
St. Vincent Mercy Medical Center
🇺🇸Toledo, Ohio, United States
Altru Cancer Center at Altru Hospital
🇺🇸Grand Forks, North Dakota, United States
Ridgeview Medical Center
🇺🇸Waconia, Minnesota, United States
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
🇺🇸Allentown, Pennsylvania, United States
Hutchinson Area Health Care
🇺🇸Hutchinson, Minnesota, United States
Mercy Hospital of Tiffin
🇺🇸Tiffin, Ohio, United States
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
🇺🇸Missoula, Montana, United States
CentraCare Clinic - River Campus
🇺🇸St. Cloud, Minnesota, United States
Bryan LGH Medical Center - West
🇺🇸Lincoln, Nebraska, United States
Toledo Hospital
🇺🇸Toledo, Ohio, United States
Northern Rockies Radiation Oncology Center
🇺🇸Billings, Montana, United States
Toledo Surgical Specialists
🇺🇸Toledo, Ohio, United States
Saint Francis Cancer Center
🇺🇸Shakopee, Minnesota, United States
Brainerd Medical Center
🇺🇸Brainerd, Minnesota, United States
St. Vincent Hospital Regional Cancer Center
🇺🇸Green Bay, Wisconsin, United States
Woodwinds Health Campus
🇺🇸Woodbury, Minnesota, United States
Bismarck Cancer Center
🇺🇸Bismarck, North Dakota, United States
St. Alexius Medical Center
🇺🇸Bismarck, North Dakota, United States
MeritCare Medical Group
🇺🇸Fargo, North Dakota, United States
Chippewa County - Montevideo Hospital
🇺🇸Montevideo, Minnesota, United States
CCOP - Metro-Minnesota
🇺🇸Saint Louis Park, Minnesota, United States
Northwest Ohio Oncology Center
🇺🇸Maumee, Ohio, United States
Fulton County Health Center
🇺🇸Wauseon, Ohio, United States
Geisinger Medical Center
🇺🇸Danville, Pennsylvania, United States
Allegheny Cancer Center at Allegheny General Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
CCOP - Toledo Community Hospital
🇺🇸Toledo, Ohio, United States
North Coast Cancer Care, Incorporated
🇺🇸Sandusky, Ohio, United States
CCOP - Upstate Carolina
🇺🇸Spartanburg, South Carolina, United States
St. Mary's Hospital Medical Center - Green Bay
🇺🇸Green Bay, Wisconsin, United States
Green Bay Oncology, Limited at St. Vincent Hospital
🇺🇸Green Bay, Wisconsin, United States
Bay Area Cancer Care Center at Bay Area Medical Center
🇺🇸Marinette, Wisconsin, United States
Green Bay Oncology, Limited - Sturgeon Bay
🇺🇸Sturgeon Bay, Wisconsin, United States
Franciscan Skemp Healthcare
🇺🇸La Crosse, Wisconsin, United States
Green Bay Oncology, Limited - Oconto Falls
🇺🇸Oconto Falls, Wisconsin, United States
Swedish Medical Center
🇺🇸Englewood, Colorado, United States
Hope Cancer Care Center at Longmont United Hospital
🇺🇸Longmont, Colorado, United States
Galesburg Clinic
🇺🇸Galesburg, Illinois, United States
Mason District Hospital
🇺🇸Havana, Illinois, United States
Perry Memorial Hospital
🇺🇸Princeton, Illinois, United States
Siouxland Regional Cancer Center
🇺🇸Sioux City, Iowa, United States
Mercy Medical Center - Sioux City
🇺🇸Sioux City, Iowa, United States
St. Luke's Regional Medical Center
🇺🇸Sioux City, Iowa, United States
Cancer Care Center at Medcenter One Hospital
🇺🇸Bismarck, North Dakota, United States
Geisinger Medical Group - Scenery Park
🇺🇸State College, Pennsylvania, United States
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
🇺🇸Wilkes-Barre, Pennsylvania, United States
Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
🇺🇸Minneapolis, Minnesota, United States
Cancer Center of Kansas, PA - Parsons
🇺🇸Parsons, Kansas, United States
Cancer Center of Kansas, PA - Pratt
🇺🇸Pratt, Kansas, United States
Welch Cancer Center at Sheridan Memorial Hospital
🇺🇸Sheridan, Wyoming, United States
Associates in Womens Health, PA - North Review
🇺🇸Wichita, Kansas, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
🇺🇸Wichita, Kansas, United States
Cancer Center of Kansas, PA - Newton
🇺🇸Newton, Kansas, United States
Graham Hospital
🇺🇸Canton, Illinois, United States
St. Joseph Hospital
🇺🇸Denver, Colorado, United States
Rose Medical Center
🇺🇸Denver, Colorado, United States
CCOP - Colorado Cancer Research Program, Incorporated
🇺🇸Denver, Colorado, United States
Kalispell Medical Oncology
🇺🇸Kalispell, Montana, United States
Community Medical Center
🇺🇸Missoula, Montana, United States
Bozeman Deaconess Hospital
🇺🇸Bozeman, Montana, United States
Montana Cancer Specialists at Montana Cancer Center
🇺🇸Missoula, Montana, United States
St. Vincent Healthcare
🇺🇸Billings, Montana, United States
Hennepin County Medical Center - Minneapolis
🇺🇸Minneapolis, Minnesota, United States
Carle Cancer Center at Carle Foundation Hospital
🇺🇸Urbana, Illinois, United States
Medical Oncology and Hematology Associates - West Des Moines
🇺🇸West Des Moines, Iowa, United States
Boulder Community Hospital
🇺🇸Boulder, Colorado, United States
Mobile Infirmary Medical Center
🇺🇸Mobile, Alabama, United States
Porter Adventist Hospital
🇺🇸Denver, Colorado, United States
Mayo Clinic Scottsdale
🇺🇸Scottsdale, Arizona, United States
Penrose Cancer Center at Penrose Hospital
🇺🇸Colorado Springs, Colorado, United States
Presbyterian - St. Luke's Medical Center
🇺🇸Denver, Colorado, United States
Front Range Cancer Specialists
🇺🇸Fort Collins, Colorado, United States
Cancer Research Center of Hawaii
🇺🇸Honolula, Hawaii, United States
North Suburban Medical Center
🇺🇸Thorton, Colorado, United States
Joliet Oncology-Hematology Associates, Limited - West
🇺🇸Joliet, Illinois, United States
McDonough District Hospital
🇺🇸Macomb, Illinois, United States
Oncology Hematology Associates of Central Illinois, PC - Ottawa
🇺🇸Ottawa, Illinois, United States
Community Cancer Center
🇺🇸Normal, Illinois, United States
Oncology Hematology Associates of Central Illinois, PC - Peoria
🇺🇸Peoria, Illinois, United States
Methodist Medical Center of Illinois
🇺🇸Peoria, Illinois, United States
CCOP - Illinois Oncology Research Association
🇺🇸Peoria, Illinois, United States
Saint Anthony Memorial Health Centers
🇺🇸Michigan City, Indiana, United States
St. Luke's Hospital
🇺🇸Maumee, Ohio, United States
Cedar Rapids Oncology Associates
🇺🇸Cedar Rapids, Iowa, United States
Cancer Center of Kansas, PA - Salina
🇺🇸Salina, Kansas, United States
Green Bay Oncology, Limited - Escanaba
🇺🇸Escanaba, Michigan, United States
Oakwood Cancer Center at Oakwood Hospital and Medical Center
🇺🇸Dearborn, Michigan, United States
Hurley Medical Center
🇺🇸Flint, Michigan, United States
Foote Hospital
🇺🇸Jackson, Michigan, United States
Haematology-Oncology Associates of Ohio and Michigan, P.C.
🇺🇸Lambertville, Michigan, United States
Sparrow Regional Cancer Center
🇺🇸Lansing, Michigan, United States
Community Cancer Center of Monroe
🇺🇸Monroe, Michigan, United States
Fairview Southdale Hospital
🇺🇸Edina, Minnesota, United States
Mercy and Unity Cancer Center at Mercy Hospital
🇺🇸Coon Rapids, Minnesota, United States
Meeker County Memorial Hospital
🇺🇸Lichfield, Minnesota, United States
Mercy and Unity Cancer Center at Unity Hospital
🇺🇸Fridley, Minnesota, United States
Hubert H. Humphrey Cancer Center at North Memorial Medical Center
🇺🇸Robbinsdale, Minnesota, United States
Coborn Cancer Center
🇺🇸Saint Cloud, Minnesota, United States
Regions Hospital Cancer Care Center
🇺🇸St. Paul, Minnesota, United States
United Hospital
🇺🇸St. Paul, Minnesota, United States
Hematology-Oncology Centers of the Northern Rockies - Billings
🇺🇸Billings, Montana, United States
Deaconess Billings Clinic - Downtown
🇺🇸Billings, Montana, United States
St. James Community Hospital
🇺🇸Butte, Montana, United States
St. Peter's Hospital
🇺🇸Helena, Montana, United States
Kalispell Regional Medical Center
🇺🇸Kalispell, Montana, United States
Cancer Resource Center - Lincoln
🇺🇸Lincoln, Nebraska, United States
Rutherford Hospital
🇺🇸Rutherfordton, North Carolina, United States
Kenton Oncology, Incorporated
🇺🇸Kenton, Ohio, United States
Wood County Oncology Center
🇺🇸Bowling Green, Ohio, United States
Fremont Memorial Hospital
🇺🇸Fremont, Ohio, United States
St. Charles Mercy Hospital
🇺🇸Oregon, Ohio, United States
Firelands Regional Medical Center
🇺🇸Sandusky, Ohio, United States
AnMed Health Cancer Center
🇺🇸Anderson, South Carolina, United States
Medical X-Ray Center, PC
🇺🇸Sioux Falls, South Dakota, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
🇺🇸Spartanburg, South Carolina, United States
Green Bay Oncology, Limited at St. Mary's Hospital
🇺🇸Green Bay, Wisconsin, United States
Avera Cancer Institute
🇺🇸Sioux Falls, South Dakota, United States
Aurora Presbyterian Hospital
🇺🇸Aurora, Colorado, United States
CCOP - Michigan Cancer Research Consortium
🇺🇸Ann Arbor, Michigan, United States
St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital
🇺🇸Ann Arbor, Michigan, United States
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
Promedica Cancer Center at Flower Hospital
🇺🇸Sylvania, Ohio, United States
OnCare Hawaii, Incorporated - Lusitana
🇺🇸Honolulu, Hawaii, United States
Queen's Cancer Institute at Queen's Medical Center
🇺🇸Honolulu, Hawaii, United States
Straub Clinic and Hospital, Incorporated
🇺🇸Honolulu, Hawaii, United States
OnCare Hawaii, Incorporated - Kuakini
🇺🇸Honolulu, Hawaii, United States
St. Francis Medical Center
🇺🇸Honolulu, Hawaii, United States
Kapiolani Medical Center for Women and Children
🇺🇸Honolulu, Hawaii, United States
Mercy Capitol Hospital
🇺🇸Des Moines, Iowa, United States
CCOP - Iowa Oncology Research Association
🇺🇸Des Moines, Iowa, United States
John Stoddard Cancer Center at Iowa Methodist Medical Center
🇺🇸Des Moines, Iowa, United States
Mercy Cancer Center at Mercy Medical Center - Des Moines
🇺🇸Des Moines, Iowa, United States
Medical Oncology and Hematology Associates at John Stoddard Cancer Center
🇺🇸Des Moines, Iowa, United States
Medical Oncology and Hematology Associates at Mercy Cancer Center
🇺🇸Des Moines, Iowa, United States
John Stoddard Cancer Center at Iowa Lutheran Hospital
🇺🇸Des Moines, Iowa, United States
Deaconess Billings Clinic Cancer Center
🇺🇸Billings, Montana, United States