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A Phase I/II Trial of Radiation, Avastin and Tarceva for Resectable or Locally Advanced Pancreatic Adenocarcinoma

Phase 1
18 Years
Not Enrolling
Pancreatic Cancer

Thank you

Trial Information

A Phase I/II Trial of Radiation, Avastin and Tarceva for Resectable or Locally Advanced Pancreatic Adenocarcinoma

This is a phase I/II study in which up to 18 patients will be enrolled in the phase I
portion and up to an additional 26 patients in the phase II portion. Patients will be
treated with Tarceva (cohort specified dose), along with fixed doses of Avastin and
radiation therapy.

Avastin will be given as an IV dose on days 1, 15, and 29. Tarceva will be given as a once
daily by mouth. On radiation days Tarceva will be taken immediately before or after XRT.

XRT will be given to a total dose of 50.4 Gy in 28 fractions, each fraction given once daily
on Monday through Friday for 5.5 weeks

Inclusion Criteria:

- Age > 18 years

- Histologically and/or cytologically confirmed adenocarcinoma of the pancreas, T1-4,
N0-1, M0. Patients should have disease for which combined modality therapy is

- Performance status 0-2

- Life expectancy > 3 months

- Adequate hematologic, renal, hepatic function

- Calculated creatinine Cl > 50 mL/min

- Use of effective means of contraception in patients of child-bearing potential.

Exclusion Criteria:

- No prior therapy for pancreatic cancer

- Previous treatment with bevacizumab or erlotinib

- Evidence of duodenal invasion or gastric outlet obstruction

- Presence of bleeding diathesis or coagulopathy

- History or prior arterial thrombotic event

- Conditions leading to inadequate gastrointestinal tract absorption

- Poorly controlled diarrhea .

- Presence of baseline proteinuria or renal dysfunction (CrCl < 50 (Cockcroft-Gault

- Inadequately controlled hypertension

- New York Heart Association (NYHA) Grade II or greater congestive heart failure

- Clinically significant peripheral vascular disease

- Presence of central nervous system or brain metastases

- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
prior to Day 0, anticipation of need for major surgical procedure during the course
of the study

- Minor surgical procedures such as fine needle aspirations or core biopsies within 7
days prior to Day 0

- Pregnant or lactating females

- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal
abscess within 6 months prior to Day 0

- Serious, non-healing wound, ulcer, or bone fracture

- Inability to comply with study and/or follow-up procedures

- Treatment for other carcinomas within the last five years, except cured non-melanoma
skin cancer, curatively treated in-situ cervical cancer, or localized prostate cancer
with a current PSA of <1.0 mg/dL on 2 successive evaluations, at least 3 months
apart, with the most recent evaluation no more than 4 weeks prior to entry.

- Comorbid conditions that would complicate safety or compliance

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Tarceva Maximum Tolerated Dose in mg

Outcome Description:

Tarceva maximum tolerated dose in mg

Outcome Time Frame:

1 yr

Safety Issue:


Principal Investigator

Brian Czito, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Duke University Medical Center, Dept Radiation Oncology


United States: Institutional Review Board

Study ID:




Start Date:

July 2008

Completion Date:

October 2011

Related Keywords:

  • Pancreatic Cancer
  • Locally advanced
  • Unresectable
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Pancreatic Neoplasms



Duke University Medical Center Durham, North Carolina  27710