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

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00791778
First received: November 14, 2008
Last updated: March 1, 2013
Last verified: March 2013

November 14, 2008
March 1, 2013
November 2008
July 2011   (final data collection date for primary outcome measure)
Progression-free Survival (PFS), Based on Radiological or Pathologic Assessment [ Time Frame: From randomization of the first patient until 32.5 months later, assessed every 8 weeks ] [ Designated as safety issue: No ]
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.
To compare the treatment groups in terms of progression free survival (PFS) which in this setting is based on time to CT-ocumented relapse [ Time Frame: Study completion ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00791778 on ClinicalTrials.gov Archive Site
  • Time to First Pathologic CA-125 (Cancer-associated Tumor Marker) Serum Level [ Time Frame: From randomization of the first patient until 32.5 months later, assessed every 8 weeks ] [ Designated as safety issue: No ]
    Time from randomization to the first documented increase of CA-125 above the upper limit of normal. Patients without pathologic CA-125 increase at the time of analysis were censored at their last date of evaluation of CA-125.
  • Overall Survival (OS) [ Time Frame: From randomization of the first patient until 32.5 months later ] [ Designated as safety issue: No ]
    The OS time was measured from the date of randomization until the date of death due to any cause. Patients who were alive at the time of analysis were censored at the date of the last contact (last time the patient was known to be alive).
  • Time to first pathologic CA125 serum levels (needs to be confirmed with a second measurement within 2 weeks) [ Time Frame: Study completion ] [ Designated as safety issue: Yes ]
  • Overall survival (OS) [ Time Frame: Study completion ] [ Designated as safety issue: Yes ]
  • Ovarian cancer symptom response [ Time Frame: Study completion ] [ Designated as safety issue: Yes ]
  • General health status [ Time Frame: Study completion ] [ Designated as safety issue: Yes ]
  • Functional Assessment of Cancer Therapy (FACT)/National Comprehensive Cancer Network (NCCN) Ovarian Symptom Index (FOSI) Total Score at Cycle 1/Baseline [ Time Frame: At Cycle 1 (4 weeks per Cycle)/baseline ] [ Designated as safety issue: No ]
    The FOSI is an 8-item index derived from the FACT-Ovarian Cancer (FACT-O) to measure symptom response to treatment for ovarian cancer. The FOSI total score ranges from 0 (severely symptomatic) to 32 (asymptomatic).
  • FOSI Total Score at Cycle 3 [ Time Frame: At Cycle 3 (4 weeks per Cycle) ] [ Designated as safety issue: No ]
    The FOSI is an 8-item index derived from the FACT-Ovarian Cancer (FACT-O) to measure symptom response to treatment for ovarian cancer. The FOSI total score ranges from 0 (severely symptomatic) to 32 (asymptomatic).
  • Change From Baseline in FOSI Total Score at Cycle 3 [ Time Frame: Baseline and Cycle 3 (4 weeks per Cycle) ] [ Designated as safety issue: No ]
    The FOSI is an 8-item index derived from the FACT-Ovarian Cancer (FACT-O) to measure symptom response to treatment for ovarian cancer. The change is calculated as score at Cycle 3 minus baseline score. The change in FOSI total score ranges from -32 (most deterioration from baseline) to 32 (most improvement from baseline).
  • FOSI Total Score at Cycle 5 [ Time Frame: At Cycle 5 (4 weeks per Cycle) ] [ Designated as safety issue: No ]
    The FOSI is an 8-item index derived from the FACT-Ovarian Cancer (FACT-O) to measure symptom response to treatment for ovarian cancer. The FOSI total score ranges from 0 (severely symptomatic) to 32 (asymptomatic).
  • Change From Baseline in FOSI Total Score at Cycle 5 [ Time Frame: Baseline and Cycle 5 (4 weeks per Cycle) ] [ Designated as safety issue: No ]
    The FOSI is an 8-item index derived from the FACT-Ovarian Cancer (FACT-O) to measure symptom response to treatment for ovarian cancer. The change is calculated as score at Cycle 5 minus baseline score. The change in FOSI total score ranges from -32 (most deterioration from baseline) to 32 (most improvement from baseline).
  • FOSI Total Score at End of Treatment [ Time Frame: At End of treatment (up to Cycle 33, 4 weeks per Cycle) ] [ Designated as safety issue: No ]
    The FOSI is an 8-item index derived from the FACT-Ovarian Cancer (FACT-O) to measure symptom response to treatment for ovarian cancer. The FOSI total score ranges from 0 (severely symptomatic) to 32 (asymptomatic).
  • Change From Baseline in FOSI Total Score at End of Treatment [ Time Frame: Baseline and End of treatment (up to Cycle 33, 4 weeks per Cycle) ] [ Designated as safety issue: No ]
    The FOSI is an 8-item index derived from the FACT-Ovarian Cancer (FACT-O) to measure symptom response to treatment for ovarian cancer. The change is calculated as score at End of treatment minus baseline score. The change in FOSI total score ranges from -32 (most deterioration from baseline) to 32 (most improvement from baseline).
  • EuroQol-5D (EQ-5D) Index Score at Cycle 1/Baseline [ Time Frame: At Cycle 1 (4 weeks per Cycle)/baseline ] [ Designated as safety issue: No ]
    The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. These five health dimensions are summarized into a single score, the EQ-5D index score which ranges from -0.594 (worst) to 1 (best) when the United Kingdom (UK) weights are applied.
  • EQ-5D Index Score at Cycle 3 [ Time Frame: At Cycle 3 (4 weeks per Cycle) ] [ Designated as safety issue: No ]
    The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. These five health dimensions are summarized into a single score, the EQ-5D index score which ranges from -0.594 (worst) to 1 (best) when the United Kingdom (UK) weights are applied.
  • Change From Baseline in EQ-5D Index Score at Cycle 3 [ Time Frame: Baseline and Cycle 3 (4 weeks per Cycle) ] [ Designated as safety issue: No ]
    The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. These five health dimensions are summarized into a single score, the EQ-5D index. The change is calculated as score at Cycle 3 minus baseline score. The change in EQ-5D index ranges from -1.594 (most deterioration from baseline) to 1.594 (most improvement from baseline).
  • EQ-5D Index Score at Cycle 5 [ Time Frame: At Cycle 5 (4 weeks per Cycle) ] [ Designated as safety issue: No ]
    The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. These five health dimensions are summarized into a single score, the EQ-5D index score which ranges from -0.594 (worst) to 1 (best) when the United Kingdom (UK) weights are applied.
  • Change From Baseline in EQ-5D Index Score at Cycle 5 [ Time Frame: Baseline and Cycle 5 (4 weeks per Cycle) ] [ Designated as safety issue: No ]
    The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. These five health dimensions are summarized into a single score, the EQ-5D index. The change is calculated as score at Cycle 5 minus baseline score. The change in EQ-5D index ranges from -1.594 (most deterioration from baseline) to 1.594 (most improvement from baseline).
  • EQ-5D Index Score at End of Treatment [ Time Frame: At End of treatment (up to Cycle 33, 4 weeks per Cycle) ] [ Designated as safety issue: No ]
    The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. These five health dimensions are summarized into a single score, the EQ-5D index score which ranges from -0.594 (worst) to 1 (best) when the United Kingdom (UK) weights are applied.
  • Change From Baseline in EQ-5D Index Score at End of Treatment [ Time Frame: Baseline and End of treatment (up to Cycle 33, 4 weeks per Cycle) ] [ Designated as safety issue: No ]
    The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. These five health dimensions are summarized into a single score, the EQ-5D index. The change is calculated as score at End of treatment minus baseline score. The change in EQ-5D index ranges from -1.594 (most deterioration from baseline) to 1.594 (most improvement from baseline).
  • EQ-5D Visual Analogue Scale (VAS) Score at Cycle 1/Baseline [ Time Frame: At Cycle 1 (4 weeks per Cycle)/baseline ] [ Designated as safety issue: No ]
    The EQ-5D also contains a VAS, which records the respondent's self-rated health status on a vertical graduated scale. The scale ranges from 0 (worst imaginable health state) to 100 (best imaginable health state).
  • EQ-5D VAS Score at Cycle 3 [ Time Frame: At Cycle 3 (4 weeks per Cycle) ] [ Designated as safety issue: No ]
    The EQ-5D also contains a VAS, which records the respondent's self-rated health status on a vertical graduated scale. The scale ranges from 0 (worst imaginable health state) to 100 (best imaginable health state).
  • Change From Baseline in EQ-5D VAS Score at Cycle 3 [ Time Frame: Baseline and Cycle 3 (4 weeks per Cycle) ] [ Designated as safety issue: No ]
    The EQ-5D also contains a VAS, which records the respondent's self-rated health status on a vertical graduated scale. The change is calculated as score at Cycle 3 minus baseline score. The change in EQ-5D VAS ranges from -100 (most deterioration from baseline) to 100 (most improvement from baseline).
  • EQ-5D VAS Score at Cycle 5 [ Time Frame: At Cycle 5 (4 weeks per Cycle) ] [ Designated as safety issue: No ]
    The EQ-5D also contains a VAS, which records the respondent's self-rated health status on a vertical graduated scale. The scale ranges from 0 (worst imaginable health state) to 100 (best imaginable health state).
  • Change From Baseline in EQ-5D VAS Score at Cycle 5 [ Time Frame: Baseline and Cycle 5 (4 weeks per Cycle) ] [ Designated as safety issue: No ]
    The EQ-5D also contains a VAS, which records the respondent's self-rated health status on a vertical graduated scale. The change is calculated as score at Cycle 5 minus baseline score. The change in EQ-5D VAS ranges from -100 (most deterioration from baseline) to 100 (most improvement from baseline).
  • EQ-5D VAS Score at End of Treatment [ Time Frame: At End of treatment (up to Cycle 33, 4 weeks per Cycle) ] [ Designated as safety issue: No ]
    The EQ-5D also contains a VAS, which records the respondent's self-rated health status on a vertical graduated scale. The scale ranges from 0 (worst imaginable health state) to 100 (best imaginable health state).
  • Change From Baseline in EQ-5D VAS Score at End of Treatment [ Time Frame: Baseline and End of treatment (up to Cycle 33, 4 weeks per Cycle) ] [ Designated as safety issue: No ]
    The EQ-5D also contains a VAS, which records the respondent's self-rated health status on a vertical graduated scale. The change is calculated as score at End of treatment minus baseline score. The change in EQ-5D VAS ranges from -100 (most deterioration from baseline) to 100 (most improvement from baseline).
Not Provided
 
Comparison of Nexavar/Placebo as Maintenance Therapy for Patients With Advanced Ovarian or Primary Peritoneal Cancer
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Ovarian Neoplasms
  • Drug: Sorafenib (Nexavar, BAY43-9006)
    Patients in Sorafenib arm will receive 2 Sorafenib tablets (200 mg each) twice a day and in continuous administration.
  • Drug: Placebo
    Patients in Placebo arm will receive 2 matching placebo tablets twice a day and in continuous administration.
  • Experimental: Sorafenib (Nexavar, BAY43-9006)
    Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
    Intervention: Drug: Sorafenib (Nexavar, BAY43-9006)
  • Placebo Comparator: Placebo
    Participants received 2 matching placebo tablets per oral twice daily
    Intervention: Drug: Placebo
Herzog TJ, Scambia G, Kim BG, Lhommé C, Markowska J, Ray-Coquard I, Sehouli J, Colombo N, Shan M, Petrenciuc O, Oza A. A randomized phase II trial of maintenance therapy with Sorafenib in front-line ovarian carcinoma. Gynecol Oncol. 2013 Jul;130(1):25-30. doi: 10.1016/j.ygyno.2013.04.011. Epub 2013 Apr 13.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
246
December 2012
July 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy,   United States,   Belgium,   Canada,   Finland,   France,   Germany,   Hong Kong,   Spain,   Japan,   Korea, Republic of,   Netherlands,   Poland,   Singapore
 
NCT00791778
12007, 2008-004429-41
No
Therapeutic Area Head, Bayer Healthcare Pharmaceuticals Inc.
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP