A Double-Blind, Randomized Phase II Study Evaluating the Efficacy and Safety of Sorafenib Compared to Placebo in Ovarian Epithelial Cancer or Primary Peritoneal Cancer Patients Who Have Achieved a Complete Clinical Response After Standard Platinum/Taxane Containing Chemotherapy
18 Years
N/A
Both
Ovarian Neoplasms
Trial Information
A Double-Blind, Randomized Phase II Study Evaluating the Efficacy and Safety of Sorafenib Compared to Placebo in Ovarian Epithelial Cancer or Primary Peritoneal Cancer Patients Who Have Achieved a Complete Clinical Response After Standard Platinum/Taxane Containing Chemotherapy
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Outcome Measure:
Progression-free Survival (PFS), Based on Radiological or Pathologic Assessment
Outcome Description:
Time from randomization to the first documented disease progression by radiological or pathologic assessment or death due to any cause whichever occurred first. For patients who had not progressed or died at the time of analysis, PFS was censored at the date of their last evaluable tumor scan.
Outcome Time Frame:
From randomization of the first patient until 32.5 months later, assessed every 8 weeks
Safety Issue:
No
Principal Investigator
Bayer Study Director
Investigator Role:
Study Director
Investigator Affiliation:
Bayer
Authority:
United States: Food and Drug Administration
Study ID:
12007
NCT ID:
NCT00791778
Start Date:
November 2008
Completion Date:
December 2012
Related Keywords:
- Ovarian Neoplasms
- Peritoneal Neoplasma
- Neoplasms
- Ovarian Neoplasms
Name | Location |
|---|---|
| Albany, Georgia 31701 | |
| Fountain Valley, California 92708 | |
| Miami, Florida 33176 | |
| Scarborough, Maine 04074 |
