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

Primary Purpose

Pancreatic Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Avastin
Tarceva
Radiation Therapy
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring Locally advanced, Unresectable

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Duke University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Avastin, Tarceva and Radiation Therapy

Outcomes

Primary Outcome Measures

Tarceva Maximum Tolerated Dose in mg
Tarceva maximum tolerated dose in mg

Secondary Outcome Measures

Number of Dose Limiting Toxicities
One Year Overall Survival From Time of Diagnosis
One year survival from time of diagnosis for patients who completed this regimen

Full Information

First Posted
August 13, 2008
Last Updated
May 22, 2015
Sponsor
Duke University
Collaborators
Genentech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00735306
Brief Title
Phase I/II Trial of Radiation, Avastin and Tarceva for Pancreatic Adenocarcinoma
Acronym
TART
Official Title
A Phase I/II Trial of Radiation, Avastin and Tarceva for Resectable or Locally Advanced Pancreatic Adenocarcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
Genentech, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.
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 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
Locally advanced, Unresectable

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Avastin, Tarceva and Radiation Therapy
Intervention Type
Drug
Intervention Name(s)
Avastin
Other Intervention Name(s)
bevacizumab
Intervention Description
Avastin 10 mg/kg IV on days 1, 15 and 29 Begins the first day of radiation therapy
Intervention Type
Drug
Intervention Name(s)
Tarceva
Other Intervention Name(s)
erlotinib
Intervention Description
Daily by mouth per assigned dose, for 5.5 weeks Begins the first day of radiation therapy
Intervention Type
Radiation
Intervention Name(s)
Radiation Therapy
Intervention Description
Radiation to the pancreas Monday through Friday for 28 treatments
Primary Outcome Measure Information:
Title
Tarceva Maximum Tolerated Dose in mg
Description
Tarceva maximum tolerated dose in mg
Time Frame
1 yr
Secondary Outcome Measure Information:
Title
Number of Dose Limiting Toxicities
Time Frame
Within 30 days of completing radiation
Title
One Year Overall Survival From Time of Diagnosis
Description
One year survival from time of diagnosis for patients who completed this regimen
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Czito, MD
Organizational Affiliation
Duke University Medical Center, Dept Radiation Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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