Status:
COMPLETED
Phase I/II Trial of Radiation, Avastin and Tarceva for Pancreatic Adenocarcinoma
Lead Sponsor:
Duke University
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 o...
Detailed 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00735306
Start Date
July 1 2008
End Date
October 1 2011
Last Update
June 18 2015
Active Locations (1)
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1
Duke University Medical Center
Durham, North Carolina, United States, 27710