Efficacy of Neoadjuvant Chemoradiation for Potentially Resectable Pancreas Cancer

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
Amer Zureikat
Study ID
NCT00557492
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Avastin (bevacizumab) — DRUG
    10 mg/kg, days 1, 15, 29 and 43
  • Gemzar (Gemcitabine) — DRUG
    On days 1, 15, and 29, subjects will receive gemcitabine 1500 mg/m2 IV over 150 minutes at the fixed-dose rate (10 mg/m2/min).
  • external beam radiotherapy — RADIATION
    3 Gy/fraction utilizing a 95% isodose field over 10 consecutive weekdays, Monday to Friday, for a total of 30 Gy

Study Details

This study is to determine the efficacy of bevacizumab and gemcitabine in combination with radiation therapy in the preoperative treatment of potentially-resectable subjects with pancreatic cancer.

Key Dates

First listed
Nov 14, 2007
Start date
Dec 31, 2006
Status verified
Aug 2018
Primary completion
Mar 31, 2012
Completion
Dec 31, 2016

Study Design

Enrollment
59 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Single Arm
    Intervention: Drug: Avastin (bevacizumab) 10 mg/kg, days 1, 15, 29 and 43 Intervention: Drug: Gemzar (Gemcitabine) On days 1, 15, and 29, subjects will receive gemcitabine 1500 mg/m2 IV over 150 minutes at the fixed-dose rate (10 mg/m2/min). Intervention:Radiation: external beam radiotherapy 3 Gy/fraction utilizing a 95% isodose field over 10 consecutive weekdays, Monday to Friday, for a total of 30 Gy

Primary Outcome Measure

Rate of Margin Negative Surgical Resection (R0 Resection Rate) [ Time Frame: Up to 48 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Pittsburgh Medical CentersPittsburghPennsylvania15232-

Find similar trials in Pittsburgh, PA

By condition
Pancreatic cancer
By specialty
OncologyGI oncology
By research site
University of Pittsburgh Medical Centers· Pittsburgh, PA

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