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NCT00112528

Bevacizumab, Gemcitabine, and Oxaliplatin in Treating Patients With Metastatic Pancreatic Cancer

Last Updated: 2016-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Study Completion Date

2010-11-30

Brief Summary

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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

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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.

Conditions

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Pancreatic Cancer

Keywords

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duct cell adenocarcinoma of the pancreas recurrent pancreatic cancer stage IV pancreatic cancer

Study Design

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Allocation Method

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

bevacizumab

Intervention Type BIOLOGICAL

gemcitabine hydrochloride

Intervention Type DRUG

oxaliplatin

Intervention Type DRUG

Interventions

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bevacizumab

Intervention Type BIOLOGICAL

gemcitabine hydrochloride

Intervention Type DRUG

oxaliplatin

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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George P. Kim, MD

Role: STUDY_CHAIR

Mayo Clinic

Locations

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Mobile Infirmary Medical Center

Mobile, Alabama, United States

Site Status

Mayo Clinic Scottsdale

Scottsdale, Arizona, United States

Site Status

Aurora Presbyterian Hospital

Aurora, Colorado, United States

Site Status

Boulder Community Hospital

Boulder, Colorado, United States

Site Status

Penrose Cancer Center at Penrose Hospital

Colorado Springs, Colorado, United States

Site Status

Porter Adventist Hospital

Denver, Colorado, United States

Site Status

Presbyterian - St. Luke's Medical Center

Denver, Colorado, United States

Site Status

St. Joseph Hospital

Denver, Colorado, United States

Site Status

Rose Medical Center

Denver, Colorado, United States

Site Status

CCOP - Colorado Cancer Research Program, Incorporated

Denver, Colorado, United States

Site Status

Swedish Medical Center

Englewood, Colorado, United States

Site Status

Front Range Cancer Specialists

Fort Collins, Colorado, United States

Site Status

Sky Ridge Medical Center

Lone Tree, Colorado, United States

Site Status

Hope Cancer Care Center at Longmont United Hospital

Longmont, Colorado, United States

Site Status

St. Mary-Corwin Regional Medical Center

Pueblo, Colorado, United States

Site Status

North Suburban Medical Center

Thorton, Colorado, United States

Site Status

Mayo Clinic - Jacksonville

Jacksonville, Florida, United States

Site Status

Cancer Research Center of Hawaii

Honolula, Hawaii, United States

Site Status

OnCare Hawaii, Incorporated - Lusitana

Honolulu, Hawaii, United States

Site Status

Queen's Cancer Institute at Queen's Medical Center

Honolulu, Hawaii, United States

Site Status

Straub Clinic and Hospital, Incorporated

Honolulu, Hawaii, United States

Site Status

OnCare Hawaii, Incorporated - Kuakini

Honolulu, Hawaii, United States

Site Status

St. Francis Medical Center

Honolulu, Hawaii, United States

Site Status

Kapiolani Medical Center for Women and Children

Honolulu, Hawaii, United States

Site Status

Kapiolani Medical Center at Pali Momi

‘Aiea, Hawaii, United States

Site Status

Rush-Copley Cancer Care Center

Aurora, Illinois, United States

Site Status

St. Joseph Medical Center

Bloomington, Illinois, United States

Site Status

Graham Hospital

Canton, Illinois, United States

Site Status

Memorial Hospital

Carthage, Illinois, United States

Site Status

St. Anthony's Memorial Hospital

Effingham, Illinois, United States

Site Status

Eureka Community Hospital

Eureka, Illinois, United States

Site Status

Galesburg Clinic

Galesburg, Illinois, United States

Site Status

Galesburg Cottage Hospital

Galesburg, Illinois, United States

Site Status

Mason District Hospital

Havana, Illinois, United States

Site Status

Hopedale Medical Complex

Hopedale, Illinois, United States

Site Status

Joliet Oncology-Hematology Associates, Limited - West

Joliet, Illinois, United States

Site Status

Kewanee Hospital

Kewanee, Illinois, United States

Site Status

McDonough District Hospital

Macomb, Illinois, United States

Site Status

Trinity Medical Center - East

Moline, Illinois, United States

Site Status

Moline, Illinois, United States

Site Status

BroMenn Regional Medical Center

Normal, Illinois, United States

Site Status

Community Cancer Center

Normal, Illinois, United States

Site Status

Community Hospital of Ottawa

Ottawa, Illinois, United States

Site Status

Oncology Hematology Associates of Central Illinois, PC - Ottawa

Ottawa, Illinois, United States

Site Status

Cancer Treatment Center at Pekin Hospital

Pekin, Illinois, United States

Site Status

Proctor Hospital

Peoria, Illinois, United States

Site Status

CCOP - Illinois Oncology Research Association

Peoria, Illinois, United States

Site Status

Oncology Hematology Associates of Central Illinois, PC - Peoria

Peoria, Illinois, United States

Site Status

Methodist Medical Center of Illinois

Peoria, Illinois, United States

Site Status

OSF St. Francis Medical Center

Peoria, Illinois, United States

Site Status

Illinois Valley Community Hospital

Peru, Illinois, United States

Site Status

Perry Memorial Hospital

Princeton, Illinois, United States

Site Status

St. Margaret's Hospital

Spring Valley, Illinois, United States

Site Status

Carle Cancer Center at Carle Foundation Hospital

Urbana, Illinois, United States

Site Status

CCOP - Carle Cancer Center

Urbana, Illinois, United States

Site Status

Saint Anthony Memorial Health Centers

Michigan City, Indiana, United States

Site Status

McFarland Clinic, P. C.

Ames, Iowa, United States

Site Status

Bettendorf, Iowa, United States

Site Status

St. Luke's Hospital

Cedar Rapids, Iowa, United States

Site Status

Cedar Rapids Oncology Associates

Cedar Rapids, Iowa, United States

Site Status