EFC 10547
| Principal Investigator: | Peter Kozuch, MD |
| Time frame of study: | Ongoing |
| Location of Study: | Beth Israel Medical Center |
| Contact: | Continuum Cancer Research Program |
Summary:
Since 1997, Gemcitabine has remained the standard of care for the treatment
of metastatic pancreatic cancer (MPC) and has demonstrated a statistically
significant improvement in clinical benefit response for these patients.
Aflibercept was designed to prevent the growth of primary and metastatic
tumors by reducing tumor blood flow. It also enhances intratumoral delivery
of chemotherapy (gemcitabine). We therefore propose this randomized study
to investigate the efficacy and safety of the addition of Aflibercept
to Gemcitabine in the first-line treatment of MPC.
Eligibility and Treatment Plan:
Patients = 18 years old with cytologically/histologically confirmed adenocarcinoma
of the exocrine pancreas with metastatic disease, & have had no prior
chemotherapy for pancreatic disease.
Patients will be randomly assigned to one of the following study arms:
Arm A) Aflibercept + Gemcitabine
Arm B) Placebo + Gemcitabine
Benefits and/or Compensation:
Participants will receive the investigational agent Aflibercept or placebo
at no charge under the supervision and care of a team of medical professionals.
Patients and/or their health plan will need to pay for some or all the
other costs of treating your cancer in this trial. The information gathered
from this study may be beneficial to future patients, and Aflibercept
may improve the overall survival for patients with metastatic pancreatic
cancer.
Copyright © 2008