Cancer

Title
Study of an Investigational Medication in Patients with Stage III-IV Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancers
Trial Number
204702
Number of Participants
2,000
Principal Investigator

Ronald K. Potkul

M.D., FACS, FACOG
Gynecologic Oncology
Mary Isabelle Caestecker Professor of Obstetrics and Gynecology
Eligibility

Participants must be 18 years of age or older, with FIGO Stages III-IV epithelial ovarian, primary peritoneal or fallopian tube cancer with an indication for first-line treatment with paclitaxel and carboplatin for six weeks. Patients with FIGO Stage IIIA or IIIB disease must have undergone PDS for ovarian, primary peritoneal or fallopian tube within 12 weeks prior to randomization. Patients must have an ECOG Performance Status of 0 or 1. Patients also must have adequate bone marrow, renal and hepatic function.

Purpose

The purpose of this study is to find out more about the experimental treatment, AMG 386, in women with advanced epithelial ovarian, primary peritoneal or fallopian tube cancers. This study also will see if treatment with paclitaxel and carboplatin (chemotherapy) plus AMG 386 followed by 18 months of AMG 386 continued after the chemotherapy will have an improved outcome compared with treatment with paclitaxel and carboplatin plus a placebo (an inactive substance), which would be followed by 18 months of a placebo.

Enrollment

(708) 327-2831

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