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
  Purpose

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.


Condition Intervention Phase
Ovarian Neoplasms
Drug: Sorafenib (Nexavar, BAY43-9006)
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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).


Other Outcome Measures:
  • 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).


Enrollment: 246
Study Start Date: November 2008
Study Completion Date: December 2012
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sorafenib (Nexavar, BAY43-9006)
Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
Drug: Sorafenib (Nexavar, BAY43-9006)
Patients in Sorafenib arm will receive 2 Sorafenib tablets (200 mg each) twice a day and in continuous administration.
Placebo Comparator: Placebo
Participants received 2 matching placebo tablets per oral twice daily
Drug: Placebo
Patients in Placebo arm will receive 2 matching placebo tablets twice a day and in continuous administration.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00791778

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Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided by Bayer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Therapeutic Area Head, Bayer Healthcare Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT00791778     History of Changes
Other Study ID Numbers: 12007, 2008-004429-41
Study First Received: November 14, 2008
Results First Received: November 1, 2012
Last Updated: March 1, 2013
Health Authority: United States: Food and Drug Administration
Belgium: Federal Agency for Medicinal Products and Health Products
Canada: Health Canada
Finland: Finnish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Hong Kong: Department of Health
Italy: Ministry of Health
Japan: Ministry of Health, Labor and Welfare
South Korea: Korea Food and Drug Administration (KFDA)
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Poland: Ministry of Health
Singapore: Health Sciences Authority
Spain: Ministry of Health

Keywords provided by Bayer:
Peritoneal Neoplasma

Additional relevant MeSH terms:
Neoplasms
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Sorafenib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 14, 2014