CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 12 enrolled
Drug / intervention
Avastin +2 moredrug
Likely dose
Avastin 10 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00735306
NCT00735306Phase 1Completed

A Phase I/II Trial of Radiation, Avastin and Tarceva for Resectable or Locally Advanced Pancreatic Adenocarcinoma

Duke University·interventional·Posted Aug 14, 2008·Updated Jun 18, 2015

In Brief

A Phase 1 clinical trial evaluating Avastin, Tarceva, and 1 other intervention for Pancreatic Cancer. Completed, enrolled 12 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsGenentech, Inc.

Timeline

Phase 1CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 14, 2008
Enrollment StartJul 1, 2008
Primary CompletionAug 1, 2011
Study CompletionOct 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 17.9 years ago

Interventions

Avastindrug

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

Tarcevadrug

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

Radiation Therapyradiation

Radiation to the pancreas Monday through Friday for 28 treatments