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

NCT00735306 | Completed Phase 1 Results

• 1 other identifier: Pro00001597
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer

Keywords

Locally advanced; Unresectable

Outcome Measures

Primary Outcomes (1)

• Tarceva Maximum Tolerated Dose in mg

  Tarceva maximum tolerated dose in mg

  1 yr

Secondary Outcomes (2)

• Number of Dose Limiting Toxicities

  Within 30 days of completing radiation

• One Year Overall Survival From Time of Diagnosis

  1 year

Study Arms (1)

1

EXPERIMENTAL

Avastin, Tarceva and Radiation Therapy

Drug: Avastin; Drug: Tarceva; Radiation: Radiation Therapy

Interventions

Avastin DRUG

Avastin 10 mg/kg IV on days 1, 15 and 29 Begins the first day of radiation therapy

Also known as: bevacizumab

1

Tarceva DRUG

Daily by mouth per assigned dose, for 5.5 weeks Begins the first day of radiation therapy

Also known as: erlotinib

1

Radiation Therapy RADIATION

Radiation to the pancreas Monday through Friday for 28 treatments

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead
• Genentech, Inc.: collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Bevacizumab; Erlotinib Hydrochloride; Radiotherapy

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Therapeutics

Results Point of Contact

• Title: Dr. Brian Czito
• Organization: Duke University

brian.czito@duke.edu

919-668-7336

Study Officials

• Brian Czito, MD

  Duke University Medical Center, Dept Radiation Oncology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2008
• First Posted: August 14, 2008
• Study Start: July 1, 2008
• Primary Completion: August 1, 2011
• Study Completion: October 1, 2011
• Last Updated: June 18, 2015
• Results First Posted: November 24, 2011

Record last verified: 2015-04

Locations

US (1)