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Completed

NCT Number: NCT00791778

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

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.

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Key information

Conditions

Ovarian Neoplasms Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Bruxelles - Brussel, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sorafenib (Nexavar, BAY43-9006)

Drug

Patients in Sorafenib arm will receive 2 Sorafenib tablets (200 mg each) twice a day and in continuous administration.

Placebo

Drug

Patients in Placebo arm will receive 2 matching placebo tablets twice a day and in continuous administration.

Primary outcomes

  1. 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

    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 outcomes

  1. 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

    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.

  2. Overall Survival (OS)

    Time frame: From randomization of the first patient until 32.5 months later

    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 outcomes

  1. 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

    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).

  2. FOSI Total Score at Cycle 3

    Time frame: At Cycle 3 (4 weeks per Cycle)

    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).

  3. Change From Baseline in FOSI Total Score at Cycle 3

    Time frame: Baseline and Cycle 3 (4 weeks per Cycle)

    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).

  4. FOSI Total Score at Cycle 5

    Time frame: At Cycle 5 (4 weeks per Cycle)

    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).

  5. Change From Baseline in FOSI Total Score at Cycle 5

    Time frame: Baseline and Cycle 5 (4 weeks per Cycle)

    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).

  6. FOSI Total Score at End of Treatment

    Time frame: At End of treatment (up to Cycle 33, 4 weeks per Cycle)

    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).

  7. 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)

    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).

  8. EuroQol-5D (EQ-5D) Index Score at Cycle 1/Baseline

    Time frame: At Cycle 1 (4 weeks per Cycle)/baseline

    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.

  9. EQ-5D Index Score at Cycle 3

    Time frame: At Cycle 3 (4 weeks per Cycle)

    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.

  10. Change From Baseline in EQ-5D Index Score at Cycle 3

    Time frame: Baseline and Cycle 3 (4 weeks per Cycle)

    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).

  11. EQ-5D Index Score at Cycle 5

    Time frame: At Cycle 5 (4 weeks per Cycle)

    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.

  12. Change From Baseline in EQ-5D Index Score at Cycle 5

    Time frame: Baseline and Cycle 5 (4 weeks per Cycle)

    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).

  13. EQ-5D Index Score at End of Treatment

    Time frame: At End of treatment (up to Cycle 33, 4 weeks per Cycle)

    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.

  14. 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)

    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).

  15. EQ-5D Visual Analogue Scale (VAS) Score at Cycle 1/Baseline

    Time frame: At Cycle 1 (4 weeks per Cycle)/baseline

    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).

  16. EQ-5D VAS Score at Cycle 3

    Time frame: At Cycle 3 (4 weeks per Cycle)

    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).

  17. Change From Baseline in EQ-5D VAS Score at Cycle 3

    Time frame: Baseline and Cycle 3 (4 weeks per Cycle)

    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).

  18. EQ-5D VAS Score at Cycle 5

    Time frame: At Cycle 5 (4 weeks per Cycle)

    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).

  19. Change From Baseline in EQ-5D VAS Score at Cycle 5

    Time frame: Baseline and Cycle 5 (4 weeks per Cycle)

    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).

  20. EQ-5D VAS Score at End of Treatment

    Time frame: At End of treatment (up to Cycle 33, 4 weeks per Cycle)

    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).

  21. 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)

    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).

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2011
Study completion
2012
First posted
Nov 17, 2008
Registry last updated
Sep 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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