TRINOVA-3/Amgen: GOG 3001 Study

TRINOVA-3/Amgen: GOG 3001 Study

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A phase 3 randomized, double-blind, placebo-controlled, multicenter study of AMG 386 with paclitaxel and carboplatin as first-line treatment of subjects with FIGO stage III-IV epithelial ovarian, primary peritoneal or fallopian tube cancers.

PROTOCOL ID

GOG 3001

PROTOCOL DESCRIPTION

Ovarian cancer is the sixth most common cause of cancer mortality in the U.S. Fallopian tube and peritoneal carcinomas are much less frequent but because of their marked similarity in biology and clinical presentation with ovarian cancer, they are usually grouped with together with ovarian carcinoma.

Typically patients with these types of cancer are treated with surgery or a combination of surgery and chemotherapy. The standard first line treatment of chemotherapy typically being Paclitaxel and Carboplatin.

AMG 386 is a first in class, investigational, anti-angiogenic drug that provides potent and selective inhibition of angiopoietins. In short, this means that AMG 386 is a man-made medication designed to stop the development of blood vessels in cancer tissues which are critical for the growth and spread of cancer.

The purpose of this study is to see if treatment with Paclitaxel and Carboplatin plus AMG 386, followed by 18 months of maintenance therapy with AMG386, will have an improved outcome compared to treatment with Paclitaxel and Carboplatin plus AMG 386 placebo, followed by 18 months of maintenance therapy with AMG 386 placebo. The study will also look at the safety and tolerability of the AMG 386 as well as the length of time the medication stays in the body and the method by which it leaves the body.

ELIGIBILITY CRITERIA

You may qualify for this study if you:

  • Female
  • 18 years of age or older
  • FIGO Stage III-IV epithelial ovarian, fallopian tube, or primary peritoneal cancer
  • Be willing to have surgery performed as part of their treatment
  • Life expectancy of at least 3 months
  • Generally well controlled blood pressure (Anti-Hypertensive medications for the control of hypertension allowed)
  • Adequate organ and blood function as evidenced by laboratory studies

Primary Investigator(s)

Janet L. Osborne, M.D.

Contact Information

Vickie Yates, RN
Clinical Research Nurse Coordinator
Phone: 540-204-7635
Email: vlyates@carilionclinic.org