Bevacizumab, Gemcitabine, And Oxaliplatin In Treating Patients With Metastatic Pancreatic Cancer

Study Overview

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

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.

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.

Pancreatic Cancer

BIOLOGICAL: bevacizumab
DRUG: gemcitabine hydrochloride
DRUG: oxaliplatin

NCCTG-N034A
NCI-2012-02655 (REGISTRY Identifier) (REGISTRY: CTRP (Clinical Trials Reporting System))
CDR0000430845 (REGISTRY Identifier) (REGISTRY: PDQ (Physician Data Query))

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2005-06-02	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2016-12-09
First Submitted that Met QC Criteria 2005-06-02	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2016-12-13
First Posted (ESTIMATED) 2005-06-03	Results First Posted N/A	Last Verified 2016-12

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
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 unaccept	BIOLOGICAL: bevacizumab DRUG: gemcitabine hydrochloride DRUG: oxaliplatin

Participant Group/Arm

Intervention/Treatment

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 unaccept

BIOLOGICAL: bevacizumab

DRUG: gemcitabine hydrochloride

DRUG: oxaliplatin

Primary Outcome Measures	Measure Description	Time Frame
Survival at 6 months		at 6 months

Secondary Outcome Measures	Measure Description	Time Frame
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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

18 and over

ECOG 0-2

At least 6 months

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

Bilirubin ≤ 2 times upper limit of normal (ULN) (stenting allowed)
AST ≤ 5 times ULN
No esophageal varices

Creatinine ≤ 2 times ULN
Proteinuria < 1+ by dipstick or urinalysis OR
Protein < 1 g/24-hr urine collection
No nephrotic syndrome

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

No hemoptysis within the past 6 months

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

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

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

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

Not specified

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

More than 4 weeks since prior major surgery or trauma and recovered
No concurrent surgery

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

National Cancer Institute (NCI)

Investigators

STUDY_CHAIR: George P. Kim, MD, Mayo Clinic

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Kim GP, Alberts SR, Oberg AL, et al.: Phase II trial of bevacizumab, gemcitabine, and oxaliplatin in patients with metastatic pancreatic adenocarcinoma. [Abstract] American Society of Clinical Oncology 2007 Gastrointestinal Cancers Symposium, 19 -21 January 2007, Orlando, Florida A-169, 2007.

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