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

This study has been completed.
Sponsor:
Collaborator:
Genentech
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00735306
First received: August 13, 2008
Last updated: May 21, 2013
Last verified: December 2011
  Purpose

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 Intervention Phase
Pancreatic Cancer
Drug: Avastin
Drug: Tarceva
Radiation: Radiation Therapy
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I/II Trial of Radiation, Avastin and Tarceva for Resectable or Locally Advanced Pancreatic Adenocarcinoma

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Tarceva Maximum Tolerated Dose in mg [ Time Frame: 1 yr ] [ Designated as safety issue: Yes ]
    Tarceva maximum tolerated dose in mg


Secondary Outcome Measures:
  • Number of Dose Limiting Toxicities [ Time Frame: Within 30 days of completing radiation ] [ Designated as safety issue: Yes ]
  • Overall Survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Average survival (months) from date of diagnosis to death


Enrollment: 12
Study Start Date: July 2008
Study Completion Date: October 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00735306

Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Genentech
Investigators
Principal Investigator: Brian Czito, MD Duke University Medical Center, Dept Radiation Oncology
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00735306     History of Changes
Other Study ID Numbers: Pro00001597
Study First Received: August 13, 2008
Results First Received: October 14, 2011
Last Updated: May 21, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
Locally advanced
Unresectable

Additional relevant MeSH terms:
Adenocarcinoma
Pancreatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Bevacizumab
Erlotinib
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 19, 2014