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A Pilot Study of Bevacizumab Based Peri-Operative Therapy for Operable Pancreatic Adenocarcinoma

18 Years
Not Enrolling
Pancreatic Cancer

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Trial Information

A Pilot Study of Bevacizumab Based Peri-Operative Therapy for Operable Pancreatic Adenocarcinoma



- To determine the feasibility and safety of bevacizumab-based neoadjuvant and adjuvant
therapy in patients with resectable pancreatic adenocarcinoma.

- To determine the proportion of patients with margin-positive resections after
pancreatic resection.


- To estimate overall survival of patients treated with this regimen.

- To assess the time to recurrence in patients treated with this regimen.

- To measure the change in the number of circulating endothelial precursor cells (CEC)
and VEGF expression on CEC at baseline and after the start of neoadjuvant therapy and
examine their relationship with response, time to recurrence, and survival.

- To assess the utility of dynamic contrast-enhanced spiral CT scan as surrogate
endpoints for antiangiogenic therapy.

OUTLINE: This is a multicenter study.

- Neoadjuvant therapy: Patients receive gemcitabine IV over 30 minutes on days 1 and 8;
oral capecitabine twice daily on days 1-14; and bevacizumab* IV over 30-90 minutes on
day 1. Treatment repeats every 3 weeks for up to 3 courses in the absence of disease
progression or unacceptable toxicity.

NOTE: *Patients receive bevacizumab during courses 1 and 2 only.

- Surgical resection: Within 6-8 weeks after the last dose of bevacizumab, patients
undergo surgical resection of the pancreatic tumor.

- Adjuvant therapy: Beginning 6-10 weeks after surgery, patients receive up to 6
additional courses of gemcitabine, capecitabine, and bevacizumab as in neoadjuvant

Patients undergo blood sample collection at baseline and periodically during study for
biomarker correlative studies. Samples are analyzed by flow cytometry to measure levels of
circulating endothelial precursor cells and VEGF markers of angiogenesis. Patients also
undergo dynamic contrast-enhanced (DCE) spiral CT scan of the abdomen. DCE-CT imaging
studies are performed at baseline and after completion of neoadjuvant therapy (1-2 weeks
prior to surgical resection) to assess changes in tumor blood flow, blood volume, and tumor

After completion of study therapy, patients are followed periodically for at least 5 years.

Inclusion Criteria


- Histologically or cytologically confirmed pancreatic adenocarcinoma

- Resectable disease (i.e., stage I or II disease)

- No unresectable (i.e., locally advanced) disease

- No tumor invasion into the stomach or duodenum

- No CNS, brain, or systemic metastases


- ECOG performance status 0-1

- WBC > 3,000/μL

- ANC > 1,500/μL

- Platelet count > 100,000/μL

- Total bilirubin < 2 mg/dL

- AST or ALT < 2.5 times upper limit of normal (ULN)

- Creatinine < 1.5 mg/dL

- Creatinine clearance ≥ 50 mL/min

- Urine protein:creatinine ratio < 1.0

- Hemoglobin ≥ 9 g/dL (transfusion, epoetin alfa, or darbepoetin allowed)

- INR < 1.5 times ULN (except in patients receiving full-dose warfarin)

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No uncontrolled hypertension

- No unstable angina

- No New York Heart Association class II-IV congestive heart failure

- No myocardial infarction or stroke within the past 6 months

- No clinically significant peripheral vascular disease

- No evidence of bleeding diathesis or coagulopathy

- No significant traumatic injury within the past 28 days

- No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within
the past 6 months

- No esophageal or gastric varices

- No serious nonhealing wound, ulcer, or bone fracture


- No prior therapy for pancreatic cancer

- More than 4 weeks since prior and no concurrent participation in another experimental
drug study

- More than 28 days since prior major surgical procedure or open biopsy

- More than 7 days since prior minor surgical procedure (e.g., fine-needle aspiration
or core biopsy)

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Feasibility and safety

Safety Issue:


Principal Investigator

Renuka Iyer, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Roswell Park Cancer Institute


United States: Federal Government

Study ID:

I 68805



Start Date:

January 2007

Completion Date:

Related Keywords:

  • Pancreatic Cancer
  • stage I pancreatic cancer
  • stage II pancreatic cancer
  • adenocarcinoma of the pancreas
  • Adenocarcinoma
  • Pancreatic Neoplasms