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

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ClinicalTrials.gov Identifier: NCT00735306
Recruitment Status : Completed
First Posted : August 14, 2008
Results First Posted : November 24, 2011
Last Update Posted : June 18, 2015
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Duke University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: Avastin Drug: Tarceva Radiation: Radiation Therapy Phase 1

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Trial of Radiation, Avastin and Tarceva for Resectable or Locally Advanced Pancreatic Adenocarcinoma
Study Start Date : July 2008
Actual Primary Completion Date : August 2011
Actual Study Completion Date : October 2011

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
Avastin, Tarceva and Radiation Therapy
 Drug: Avastin
Avastin 10 mg/kg IV on days 1, 15 and 29 Begins the first day of radiation therapy
Other Name: bevacizumab

Drug: Tarceva
Daily by mouth per assigned dose, for 5.5 weeks Begins the first day of radiation therapy
Other Name: erlotinib

Radiation: Radiation Therapy
Radiation to the pancreas Monday through Friday for 28 treatments


Outcome Measures
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Primary Outcome Measures :
  1. Tarceva Maximum Tolerated Dose in mg [ Time Frame: 1 yr ]
    Tarceva maximum tolerated dose in mg


Secondary Outcome Measures :
  1. Number of Dose Limiting Toxicities [ Time Frame: Within 30 days of completing radiation ]
  2. One Year Overall Survival From Time of Diagnosis [ Time Frame: 1 year ]
    One year survival from time of diagnosis for patients who completed this regimen


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00735306


Locations
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United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Genentech, Inc.
Investigators
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Principal Investigator: Brian Czito, MD Duke University Medical Center, Dept Radiation Oncology
More Information
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00735306    
Other Study ID Numbers: Pro00001597
First Posted: August 14, 2008    Key Record Dates
Results First Posted: November 24, 2011
Last Update Posted: June 18, 2015
Last Verified: April 2015
Keywords provided by Duke University:
Locally advanced
Unresectable
Additional relevant MeSH terms:
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Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Bevacizumab
Erlotinib Hydrochloride
Antineoplastic Agents, Immunological
Antineoplastic Agents
 Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action