Phase I/II Trial of Radiation, Avastin and Tarceva for Pancreatic Adenocarcinoma (TART)

Duke University

Status and phase

Completed

Phase 1

Conditions

Pancreatic Cancer

Treatments

Drug: Tarceva

Radiation: Radiation Therapy

Drug: Avastin

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00735306

Pro00001597

Details and patient eligibility

About

The primary purpose of this trial is to define the maximum tolerated and/or recommended phase II dose of the combination of Avastin and Tarceva in patients undergoing radiation therapy for carcinoma of the pancreas. An additional primary objective is to describe the frequency and nature of grade III/IV and grade I/II toxicities associated with this regimen. Secondary objectives include describing 1-year disease-free survival and overall survival rates as well as to estimate clinical and pathologic complete response rates associated with this regimen.

Full description

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

Enrollment

12 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 indicated.
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 equation)
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