Comparison of Nexavar/Placebo as Maintenance Therapy for Patients With Advanced Ovarian or Primary Peritoneal Cancer
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| ClinicalTrials.gov Identifier: NCT00791778 |
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Recruitment Status :
Completed
First Posted : November 17, 2008
Results First Posted : November 30, 2012
Last Update Posted : September 28, 2015
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Sponsor:
Bayer
Information provided by (Responsible Party):
Bayer
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Brief Summary:
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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Ovarian Neoplasms | Drug: Sorafenib (Nexavar, BAY43-9006) Drug: Placebo | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 246 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, 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 |
| Study Start Date : | November 2008 |
| Actual Primary Completion Date : | July 2011 |
| Actual Study Completion Date : | December 2012 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Ovarian cancer
| Arm | Intervention/treatment |
|---|---|
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Experimental: Sorafenib (Nexavar, BAY43-9006)
Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
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Drug: Sorafenib (Nexavar, BAY43-9006)
Patients in Sorafenib arm will receive 2 Sorafenib tablets (200 mg each) twice a day and in continuous administration. |
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Placebo Comparator: Placebo
Participants received 2 matching placebo tablets per oral twice daily
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Drug: Placebo
Patients in Placebo arm will receive 2 matching placebo tablets twice a day and in continuous administration. |
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 ]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 ]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 ]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 ]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) ]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) ]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) ]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) ]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) ]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) ]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 ]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) ]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) ]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) ]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) ]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) ]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) ]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 ]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) ]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) ]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) ]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) ]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) ]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) ]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).
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00791778
Locations
Show 60 study locations
Sponsors and Collaborators
Bayer
Investigators
| Study Director: | Bayer Study Director | Bayer |
Additional Information:
Publications of Results:
Publications of Results:
| Responsible Party: | Bayer |
| ClinicalTrials.gov Identifier: | NCT00791778 |
| Other Study ID Numbers: |
12007 2008-004429-41 ( EudraCT Number ) |
| First Posted: | November 17, 2008 Key Record Dates |
| Results First Posted: | November 30, 2012 |
| Last Update Posted: | September 28, 2015 |
| Last Verified: | June 2015 |
Keywords provided by Bayer:
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Peritoneal Neoplasma |
Additional relevant MeSH terms:
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Ovarian Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Neoplasms, Female Urogenital Neoplasms |
Endocrine System Diseases Gonadal Disorders Sorafenib Antineoplastic Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |