Comparison of Nexavar/Placebo as Maintenance Therapy for Patients With Advanced Ovarian or Primary Peritoneal Cancer

Completed · Phase 2 · Has a placebo group

Conditions studied: Ovarian Neoplasms

In brief

Comparison of Nexavar with a placebo as maintenance therapy for patients with advanced Ovarian or primary Peritoneal cancers in complete remission following surgery and one regimen of chemotherapy.

Key facts

Study ID

NCT00791778

Run by

Bayer

People needed

246

Starts

2008-11-01

Expected to finish

2012-12-01

Last updated by the study team

2015-09-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed International Federation of Gynecology and Obstetrics (FIGO) stage (67) III or IV ovarian epithelial cancer or primary peritoneal cancer at presentation. Patients must have achieved a clinical complete response (disappearance of all clinical and radiological evidence of tumor) after only one regimen (4-6 cycles) of platinum and taxane-based standard chemotherapy received after tumor debulkment.
• Normal serum CA125 (cancer-associated tumor marker) level within 7 days of first dose of sorafenib.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• All scans used to document complete response must be done within 30 days prior to randomization.
• Patients must be able to swallow and retain oral medication.

You may not qualify if…

• Patients with any residual cancer tissue after the completion of chemotherapy detectable by standard Computed tomography (CT) or magnetic resonance imaging (MRI).
• Prior local radiotherapy, neoadjuvant chemotherapy or intraperitoneal chemotherapy.
• Histologic subtypes of ovarian cancer other than epithelial (i.e. sarcoma, lymphoma, germ cell).
• Major surgery, open biopsy, or significant traumatic injury within 30 days prior to randomization.

Where it is running

• Study site — Jacksonville, Florida, United States
• Study site — Augusta, Georgia, United States
• Study site — Scarborough, Maine, United States
• Study site — Bruxelles - Brussel, Belgium
• Study site — Bruxelles - Brussel, Belgium
• Study site — Edegem, Belgium
• Study site — La Louvière, Belgium
• Study site — Leuven, Belgium
• Study site — Wilrijk, Belgium
• Study site — Hamilton, Ontario, Canada
• Study site — London, Ontario, Canada
• Study site — Toronto, Ontario, Canada
• Study site — Montreal, Quebec, Canada
• Study site — Jyväskylä, Finland
• Study site — Kuopio, Finland
• Study site — Angers, France
• Study site — Caen, France
• Study site — Lyon, France
• Study site — Tours, France
• Study site — Villejuif, France
• Study site — Berlin, State of Berlin, Germany
• Study site — Hong Kong, Hong Kong
• Study site — Meldola, Forlì, Italy
• Study site — Campobasso, Italy
• Study site — La Jolla, California, United States

Full record on ClinicalTrials.gov

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