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

Phase 2
18 Years
Not Enrolling
Pancreatic Cancer

Thank you

Trial Information

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



- Determine the 6-month survival of patients with metastatic adenocarcinoma of the
pancreas treated with bevacizumab, gemcitabine, and oxaliplatin.


- 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

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

Inclusion Criteria


- 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

Performance status

- ECOG 0-2

Life expectancy

- 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

- 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


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


- 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

- No prior cytotoxic chemotherapy for metastatic disease

- No prior adjuvant oxaliplatin

- No other concurrent chemotherapy

Endocrine therapy

- 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

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Survival at 6 months

Safety Issue:


Principal Investigator

George P. Kim, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic


United States: Federal Government

Study ID:




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



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Queen's Cancer Institute at Queen's Medical Center Honolulu, Hawaii  96813
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