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

This study has been completed.
Sponsor:
Collaborator:
Genentech, Inc.
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

August 13, 2008
May 21, 2013
July 2008
August 2011   (final data collection date for primary outcome measure)
Tarceva Maximum Tolerated Dose in mg [ Time Frame: 1 yr ] [ Designated as safety issue: Yes ]
Tarceva maximum tolerated dose in mg
Determine the maximal tolerated dose and/or recommended phase II dose [ Time Frame: 1 yr ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00735306 on ClinicalTrials.gov Archive Site
  • 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
  • Report the frequency and nature of grade 3-4 and grade 1-2 toxicities [ Time Frame: Within 30 days of completing radiation ] [ Designated as safety issue: Yes ]
  • Estimate the 1 year disease free and overall survival rates for the patients studied on this protocol [ Time Frame: 1 yr ] [ Designated as safety issue: No ]
  • Estimate the clinical and pathological response rates associated with this regimen [ Time Frame: 1 yr ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Phase I/II Trial of Radiation, Avastin and Tarceva for Pancreatic Adenocarcinoma
A Phase I/II Trial of Radiation, Avastin and Tarceva for Resectable or Locally Advanced Pancreatic Adenocarcinoma

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.

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

Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Pancreatic Cancer
  • 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
Experimental: 1
Avastin, Tarceva and Radiation Therapy
Interventions:
  • Drug: Avastin
  • Drug: Tarceva
  • Radiation: Radiation Therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
October 2011
August 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00735306
Pro00001597
No
Duke University
Duke University
Genentech, Inc.
Principal Investigator: Brian Czito, MD Duke University Medical Center, Dept Radiation Oncology
Duke University
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP