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


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Oxaliplatin Injection

Eloxatin



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

This study is not yet open for patient recruitment.

Sponsors and Collaborators: North Central Cancer Treatment Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

Purpose

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.

Condition Treatment or Intervention Phase
duct cell adenocarcinoma of the pancreas
stage IVA pancreatic cancer
stage IVB pancreatic cancer
recurrent pancreatic cancer
 Drug: bevacizumab
 Drug: gemcitabine
 Drug: oxaliplatin
 Procedure: anti-cytokine therapy
 Procedure: antiangiogenesis therapy
 Procedure: antibody therapy
 Procedure: biological response modifier therapy
 Procedure: chemotherapy
 Procedure: growth factor antagonist therapy
 Procedure: monoclonal antibody therapy
Phase II

MedlinePlus related topics:  Pancreatic Cancer

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of Bevacizumab, Gemcitabine, and Oxaliplatin in Patients With Metastatic Adenocarcinoma of the Pancreas

Further Study Details: 

OBJECTIVES: Primary

Secondary

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.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

PATIENT CHARACTERISTICS: Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • At least 3 months

Hematopoietic

  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 9.0 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

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

Endocrine therapy

  • Not specified

Radiotherapy

Surgery

  • More than 4 weeks since prior major surgery 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

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00112528


Study chairs or principal investigators

George P. Kim, MD,  Study Chair,  Mayo Clinic - Jacksonville   
Anthony J. Jaslowski, MD,  CCOP - St. Vincent Hospital Cancer Center, Green Bay   

More Information

Clinical trial summary from the National Cancer Institute''''s PDQ® database

Study ID Numbers:  CDR0000430845; NCCTG-N034A
Record last reviewed:  May 2005
Last Updated:  June 2, 2005
Record first received:  June 2, 2005
ClinicalTrials.gov Identifier:  NCT00112528
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-06-07

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November 18, 2008



Page Updated: June 1, 2005
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