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

Ovarian Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00791778
• Other study ID #: 12007
• Secondary ID: 2008-004429-41
• Status: Completed
• Phase: Phase 2
• First received: November 14, 2008
• Last updated: August 26, 2015
• Start date: November 2008
• Est. completion date: December 2012

Study information

• Verified date: June 2015
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationBelgium: Federal Agency for Medicinal Products and Health ProductsCanada: Health CanadaFinland: Finnish Medicines AgencyFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesHong Kong: Department of HealthItaly: Ministry of HealthJapan: Ministry of Health, Labor and WelfareSouth Korea: Korea Food and Drug Administration (KFDA)Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)Poland: Ministry of HealthSingapore: Health Sciences AuthoritySpain: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 246
• Est. completion date: December 2012
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Ovarian Neoplasms

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  Finland,  France,  Germany,  Hong Kong,  Italy,  Japan,  Korea, Republic of,  Netherlands,  Poland,  Singapore,  Spain, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Functional Assessment of Cancer Therapy (FACT)/National Comprehensive Cancer Network (NCCN) Ovarian Symptom Index (FOSI) Total Score at Cycle 1/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).	At Cycle 1 (4 weeks per Cycle)/baseline	No
Other	FOSI Total Score at Cycle 3	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).	At Cycle 3 (4 weeks per Cycle)	No
Other	Change From Baseline in FOSI Total Score at Cycle 3	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).	Baseline and Cycle 3 (4 weeks per Cycle)	No
Other	FOSI Total Score at Cycle 5	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).	At Cycle 5 (4 weeks per Cycle)	No
Other	Change From Baseline in FOSI Total Score at Cycle 5	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).	Baseline and Cycle 5 (4 weeks per Cycle)	No
Other	FOSI Total Score at End of Treatment	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).	At End of treatment (up to Cycle 33, 4 weeks per Cycle)	No
Other	Change From Baseline in FOSI Total Score at End of Treatment	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).	Baseline and End of treatment (up to Cycle 33, 4 weeks per Cycle)	No
Other	EuroQol-5D (EQ-5D) Index Score at Cycle 1/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.	At Cycle 1 (4 weeks per Cycle)/baseline	No
Other	EQ-5D Index Score at Cycle 3	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.	At Cycle 3 (4 weeks per Cycle)	No
Other	Change From Baseline in EQ-5D Index Score at Cycle 3	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).	Baseline and Cycle 3 (4 weeks per Cycle)	No
Other	EQ-5D Index Score at Cycle 5	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.	At Cycle 5 (4 weeks per Cycle)	No
Other	Change From Baseline in EQ-5D Index Score at Cycle 5	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).	Baseline and Cycle 5 (4 weeks per Cycle)	No
Other	EQ-5D Index Score at End of Treatment	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.	At End of treatment (up to Cycle 33, 4 weeks per Cycle)	No
Other	Change From Baseline in EQ-5D Index Score at End of Treatment	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).	Baseline and End of treatment (up to Cycle 33, 4 weeks per Cycle)	No
Other	EQ-5D Visual Analogue Scale (VAS) Score at Cycle 1/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).	At Cycle 1 (4 weeks per Cycle)/baseline	No
Other	EQ-5D VAS Score at Cycle 3	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).	At Cycle 3 (4 weeks per Cycle)	No
Other	Change From Baseline in EQ-5D VAS Score at Cycle 3	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).	Baseline and Cycle 3 (4 weeks per Cycle)	No
Other	EQ-5D VAS Score at Cycle 5	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).	At Cycle 5 (4 weeks per Cycle)	No
Other	Change From Baseline in EQ-5D VAS Score at Cycle 5	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).	Baseline and Cycle 5 (4 weeks per Cycle)	No
Other	EQ-5D VAS Score at End of Treatment	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).	At End of treatment (up to Cycle 33, 4 weeks per Cycle)	No
Other	Change From Baseline in EQ-5D VAS Score at End of Treatment	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).	Baseline and End of treatment (up to Cycle 33, 4 weeks per Cycle)	No
Primary	Progression-free Survival (PFS), Based on Radiological or Pathologic Assessment	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.	From randomization of the first patient until 32.5 months later, assessed every 8 weeks	No
Secondary	Time to First Pathologic CA-125 (Cancer-associated Tumor Marker) Serum Level	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.	From randomization of the first patient until 32.5 months later, assessed every 8 weeks	No
Secondary	Overall Survival (OS)	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).	From randomization of the first patient until 32.5 months later	No

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