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Phase II Trial of Bevacizumab, Gemcitabine, Oxaliplatin in Patients With Metastatic Pancreatic Adenocarcinoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Pancreatic Cancer

Thank you

Trial Information

Phase II Trial of Bevacizumab, Gemcitabine, Oxaliplatin in Patients With Metastatic Pancreatic Adenocarcinoma


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.

PROJECTED ACCRUAL: A total of 83 patients will be accrued for this study within 9 months.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Survival at 6 months

Safety Issue:

No

Principal Investigator

George P. Kim, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Federal Government

Study ID:

CDR0000430845

NCT ID:

NCT00112528

Start Date:

June 2005

Completion Date:

Related Keywords:

  • Pancreatic Cancer
  • duct cell adenocarcinoma of the pancreas
  • recurrent pancreatic cancer
  • stage IV pancreatic cancer
  • Adenocarcinoma
  • Pancreatic Neoplasms

Name

Location

Mayo Clinic ScottsdaleScottsdale, Arizona  85259
Mayo Clinic - JacksonvilleJacksonville, Florida  32224
Mayo Clinic Cancer CenterRochester, Minnesota  55905
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
CCOP - WichitaWichita, Kansas  67214-3882
Hurley Medical CenterFlint, Michigan  48503
CCOP - Illinois Oncology Research AssociationPeoria, Illinois  61602
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
Aurora Presbyterian HospitalAurora, Colorado  80012
Boulder Community HospitalBoulder, Colorado  80301-9019
Penrose Cancer Center at Penrose HospitalColorado Springs, Colorado  80933
Porter Adventist HospitalDenver, Colorado  80210
Presbyterian - St. Luke's Medical CenterDenver, Colorado  80218
St. Joseph HospitalDenver, Colorado  80218
Rose Medical CenterDenver, Colorado  80220
Swedish Medical CenterEnglewood, Colorado  80110
Sky Ridge Medical CenterLone Tree, Colorado  80124
Hope Cancer Care Center at Longmont United HospitalLongmont, Colorado  80502
North Suburban Medical CenterThornton, Colorado  80229
Rush-Copley Cancer Care CenterAurora, Illinois  60507
Joliet Oncology-Hematology Associates, Limited - WestJoliet, Illinois  60435
Carle Cancer Center at Carle Foundation HospitalUrbana, Illinois  61801
Saint Anthony Memorial Health CentersMichigan City, Indiana  46360
Cedar Rapids Oncology AssociatesCedar Rapids, Iowa  52403
Mercy Medical Center - Sioux CitySioux City, Iowa  51104
Siouxland Hematology-Oncology Associates, LLPSioux City, Iowa  51101
St. Luke's Regional Medical CenterSioux City, Iowa  51104
CCOP - Michigan Cancer Research ConsortiumAnn Arbor, Michigan  48106
Oakwood Cancer Center at Oakwood Hospital and Medical CenterDearborn, Michigan  48123-2500
Genesys Hurley Cancer InstituteFlint, Michigan  48503
Van Elslander Cancer Center at St. John Hospital and Medical CenterGrosse Pointe Woods, Michigan  48236
Foote HospitalJackson, Michigan  49201
Sparrow Regional Cancer CenterLansing, Michigan  48912-1811
Seton Cancer Institute - SaginawSaginaw, Michigan  48601
St. John Macomb HospitalWarren, Michigan  48093
Fairview Ridges HospitalBurnsville, Minnesota  55337
Mercy and Unity Cancer Center at Mercy HospitalCoon Rapids, Minnesota  55433
Fairview Southdale HospitalEdina, Minnesota  55435
Mercy and Unity Cancer Center at Unity HospitalFridley, Minnesota  55432
Hutchinson Area Health CareHutchinson, Minnesota  55350
Meeker County Memorial HospitalLichfield, Minnesota  55355
HealthEast Cancer Care at St. John's HospitalMaplewood, Minnesota  55109
Hennepin County Medical Center - MinneapolisMinneapolis, Minnesota  55415
Regions Hospital Cancer Care CenterSt. Paul, Minnesota  55101
United HospitalSt. Paul, Minnesota  55102
Ridgeview Medical CenterWaconia, Minnesota  55387
CCOP - MeritCare HospitalFargo, North Dakota  58122
Geisinger Medical CenterDanville, Pennsylvania  17822-0001
Geisinger Medical Group - Scenery ParkState College, Pennsylvania  16801
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical CenterWilkes-Barre, Pennsylvania  18711
Medical X-Ray Center, PCSioux Falls, South Dakota  57105
Avera Cancer InstituteSioux Falls, South Dakota  57105
Rapid City Regional HospitalRapid City, South Dakota  57709
Methodist Medical Center of IllinoisPeoria, Illinois  61636
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
Hinsdale, Illinois  60521
Cancer Research Center of HawaiiHonolulu, Hawaii  96813
Mobile Infirmary Medical CenterMobile, Alabama  36640-0460
John Stoddard Cancer Center at Iowa Methodist Medical CenterDes Moines, Iowa  50309
St. Vincent Mercy Medical CenterToledo, Ohio  43608
CCOP - Colorado Cancer Research Program, IncorporatedDenver, Colorado  80224
Sioux Valley Hospital and University of South Dakota Medical CenterSioux Falls, South Dakota  57117-5134
CCOP - Toledo Community HospitalToledo, Ohio  43623-3456
Via Christi Cancer Center at Via Christi Regional Medical CenterWichita, Kansas  67214
Medical University of Ohio Cancer CenterToledo, Ohio  43614
Toledo HospitalToledo, Ohio  43606
St. Vincent Hospital Regional Cancer CenterGreen Bay, Wisconsin  54307-3508
Green Bay Oncology, Limited - EscanabaEscanaba, Michigan  49431
St. Mary's Hospital Medical Center - Green BayGreen Bay, Wisconsin  54303
Green Bay Oncology, Limited at St. Mary's HospitalGreen Bay, Wisconsin  54303
Bay Area Cancer Care Center at Bay Area Medical CenterMarinette, Wisconsin  54143
Green Bay Oncology, Limited - Oconto FallsOconto Falls, Wisconsin  54154
Green Bay Oncology, Limited - Sturgeon BaySturgeon Bay, Wisconsin  54235
Siouxland Regional Cancer CenterSioux City, Iowa  51101-1733
Southwest Medical CenterLiberal, Kansas  67901
Northern Rockies Radiation Oncology CenterBillings, Montana  59101
Hematology-Oncology Centers of the Northern Rockies - BillingsBillings, Montana  59101
St. Vincent HealthcareBillings, Montana  59101
Deaconess Billings Clinic - DowntownBillings, Montana  59101
Deaconess Billings Clinic Cancer CenterBillings, Montana  59107
Bozeman Deaconess HospitalBozeman, Montana  59715
St. James Community HospitalButte, Montana  59701
St. Peter's HospitalHelena, Montana  59601
Kalispell Medical OncologyKalispell, Montana  59901
Kalispell Regional Medical CenterKalispell, Montana  59901
Glacier Oncology, PLLCKalispell, Montana  59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences CenterMissoula, Montana  59802
Montana Cancer Specialists at Montana Cancer CenterMissoula, Montana  59802
Community Medical CenterMissoula, Montana  59801
Morgan Cancer Center at Lehigh Valley Hospital - Cedar CrestAllentown, Pennsylvania  18105
Front Range Cancer SpecialistsFort Collins, Colorado  80528
St. Mary-Corwin Regional Medical CenterPueblo, Colorado  81004
St. Joseph Medical CenterBloomington, Illinois  61701
Graham HospitalCanton, Illinois  61520
Memorial HospitalCarthage, Illinois  62321
Eureka Community HospitalEureka, Illinois  61530
Galesburg Cottage HospitalGalesburg, Illinois  61401
Galesburg ClinicGalesburg, Illinois  61401
Mason District HospitalHavana, Illinois  62644
Hopedale Medical ComplexHopedale, Illinois  61747
Kewanee HospitalKewanee, Illinois  61443
McDonough District HospitalMacomb, Illinois  61455
Trinity Medical Center - EastMoline, Illinois  61265
BroMenn Regional Medical CenterNormal, Illinois  61761
Community Cancer CenterNormal, Illinois  61761
Community Hospital of OttawaOttawa, Illinois  61350
Oncology Hematology Associates of Central Illinois, PC - OttawaOttawa, Illinois  61350
Cancer Treatment Center at Pekin HospitalPekin, Illinois  61554
Oncology Hematology Associates of Central Illinois, PC - PeoriaPeoria, Illinois  61615
OSF St. Francis Medical CenterPeoria, Illinois  61637
Proctor HospitalPeoria, Illinois  61614
Illinois Valley Community HospitalPeru, Illinois  61354
Perry Memorial HospitalPrinceton, Illinois  61356
St. Margaret's HospitalSpring Valley, Illinois  61362
McFarland Clinic, P. C.Ames, Iowa  50010
Bettendorf, Iowa  52722
St. Luke's HospitalCedar Rapids, Iowa  52402
Mercy Regional Cancer Center at Mercy Medical CenterCedar Rapids, Iowa  52403
John Stoddard Cancer Center at Iowa Lutheran HospitalDes Moines, Iowa  50316-2301
Mercy Capitol HospitalDes Moines, Iowa  50307
Medical Oncology and Hematology Associates at John Stoddard Cancer CenterDes Moines, Iowa  50309
Medical Oncology and Hematology Associates at Mercy Cancer CenterDes Moines, Iowa  50314
Mercy Cancer Center at Mercy Medical Center - Des MoinesDes Moines, Iowa  50314
Medical Oncology and Hematology Associates - West Des MoinesWest Des Moines, Iowa  50266
Cancer Center of Kansas, PA - Dodge CityDodge City, Kansas  67801
Hickman Cancer Center at Bixby Medical CenterAdrian, Michigan  49221
St. Joseph Mercy Cancer Center at St. Joseph Mercy HospitalAnn Arbor, Michigan  48106-0995
Green Bay Oncology, Limited - Iron MountainIron Mountain, Michigan  49801
Haematology-Oncology Associates of Ohio and Michigan, P.C.Lambertville, Michigan  48144
Community Cancer Center of MonroeMonroe, Michigan  48162
Mercy Memorial Hospital SystemMonroe, Michigan  48162
Alexandria, Minnesota  56308
MeritCare Clinic - BemidjiBemidji, Minnesota  56601
Brainerd Medical CenterBrainerd, Minnesota  56401
St. Joseph's Medical CenterBrainerd, Minnesota  56401
Virginia Piper Cancer Institute at Abbott-Northwestern HospitalMinneapolis, Minnesota  55407
Chippewa County - Montevideo HospitalMontevideo, Minnesota  56265
Hubert H. Humphrey Cancer Center at North Memorial Medical CenterRobbinsdale, Minnesota  55422-2900
Coborn Cancer CenterSaint Cloud, Minnesota  56303
CentraCare Clinic - River CampusSt. Cloud, Minnesota  56303
Park Nicollet Health ServicesSt. Louis Park, Minnesota  55416
St. Elizabeth Regional Medical CenterLincoln, Nebraska  68510
Cancer Care Center at Medcenter One HospitalBismarck, North Dakota  58501
Bismarck Cancer CenterBismarck, North Dakota  58501
St. Alexius Medical CenterBismarck, North Dakota  58502
Mid Dakota Clinic, P. C.Bismarck, North Dakota  58501
MeritCare Medical GroupFargo, North Dakota  58122
Wood County Oncology CenterBowling Green, Ohio  43402
Blanchard Valley Medical AssociatesFindlay, Ohio  45840
Fremont Memorial HospitalFremont, Ohio  43420
Kenton Oncology, IncorporatedKenton, Ohio  43326
Lima Memorial HospitalLima, Ohio  45804
St. Luke's HospitalMaumee, Ohio  43537
Northwest Ohio Oncology CenterMaumee, Ohio  43537
Toledo Clinic - OregonOregon, Ohio  43616
St. Charles Mercy HospitalOregon, Ohio  43616
North Coast Cancer Care, IncorporatedSandusky, Ohio  44870
Firelands Regional Medical CenterSandusky, Ohio  44870
Promedica Cancer Center at Flower HospitalSylvania, Ohio  43560
Mercy Hospital of TiffinTiffin, Ohio  44883
Toledo Clinic, Incorporated - Main ClinicToledo, Ohio  43623
Toledo Surgical SpecialistsToledo, Ohio  43623
Fulton County Health CenterWauseon, Ohio  43567
Green Bay Oncology, Limited at St. Vincent HospitalGreen Bay, Wisconsin  54301-3526
Welch Cancer Center at Sheridan Memorial HospitalSheridan, Wyoming  82801
St. Anthony's Memorial HospitalEffingham, Illinois  62401
Franciscan Skemp HealthcareLa Crosse, Wisconsin  54601-4796
Saint Francis Cancer CenterShakopee, Minnesota  55379
St. Joseph's HospitalSt Paul, Minnesota  55102
Adult and Pediatric Urology, P.L.L.P.St. Cloud, Minnesota  56303
Cancer Resource Center - LincolnLincoln, Nebraska  68510
Altru Cancer Center at Altru HospitalGrand Forks, North Dakota  58201
Allegheny Cancer Center at Allegheny General HospitalPittsburgh, Pennsylvania  15212
Cancer Center of Kansas, PA - ChanuteChanute, Kansas  66720
Cancer Center of Kansas, PA - El DoradoEl Dorado, Kansas  67042
Cancer Center of Kansas, PA - KingmanKingman, Kansas  67068
Cancer Center of Kansas, PA - NewtonNewton, Kansas  67114
Cancer Center of Kansas, PA - ParsonsParsons, Kansas  67357
Cancer Center of Kansas, PA - PrattPratt, Kansas  67124
Cancer Center of Kansas, PA - SalinaSalina, Kansas  67401
Cancer Center of Kansas, PA - WellingtonWellington, Kansas  67152
Cancer Center of Kansas, PA - WichitaWichita, Kansas  67214
Associates in Womens Health, PA - North ReviewWichita, Kansas  67208
Cancer Center of Kansas, PA - Medical Arts TowerWichita, Kansas  67208
Cancer Center of Kansas, PA - WinfieldWinfield, Kansas  67156
St. Francis Medical CenterHonolulu, Hawaii  96817
Queen's Cancer Institute at Queen's Medical CenterHonolulu, Hawaii  96813
Rutherford HospitalRutherfordton, North Carolina  28139
AnMed Health Cancer CenterAnderson, South Carolina  29621
Gibbs Regional Cancer Center at Spartanburg Regional Medical CenterSpartanburg, South Carolina  29303
Woodwinds Health CampusWoodbury, Minnesota  55125
Kapiolani Medical Center at Pali MomiAiea, Hawaii  96701
Kapiolani Medical Center for Women and ChildrenHonolulu, Hawaii  96826
Straub Clinic and Hospital, IncorporatedHonolulu, Hawaii  96813
OnCare Hawaii, Incorporated - KuakiniHonolulu, Hawaii  96817
OnCare Hawaii, Incorporated - LusitanaHonolulu, Hawaii  96813
Ottumwa Regional Health Center Cancer CenterOttumwa, Iowa  52501
Bryan LGH Medical Center - WestLincoln, Nebraska  68502