NCT00945191

Combination Chemotherapy With CS-1008 to Treat Ovarian Cancer

Phase 2 Study of CS-1008 in Combination With Chemotherapy (Paclitaxel/Carboplatin) in Locally Advanced or Metastatic Ovarian Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Daiichi Sankyo · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This trial assessed the effect of treatment with CS-1008 in combination with paclitaxel/carboplatin on response in patients with locally advanced or metastatic ovarian cancer.

Detailed description

This trial assessed CS-1008 administered in combination with paclitaxel/carboplatin to patients with Stage IIIC or IV ovarian cancer who had suboptimal debulking surgery with residual measurable/evaluable disease and who had not received prior therapy for their disease. The effect of this first-line treatment in patients was assessed by complete response rate.

Conditions

• Ovarian Cancer Stage IIIC
• Ovarian Cancer Stage IV

Interventions

Type	Name	Description
DRUG	CS-1008	CS-1008 intravenous (IV) infusion 10 mg/kg on Day 1 of Cycle 1 and 8 mg/kg once every 3 weeks (1 cycle) for Cycle 2-6
DRUG	Paclitaxel	Paclitaxel 175 mg/m\^2 IV infusion once every 3 weeks (1 cycle) for 6 cycles
DRUG	Carboplatin	Carboplatin (target area under the concentration versus time curve of 6.0 mg/mL/min using the Calvert Formula) IV infusion once every 3 weeks (1 cycle) for 6 cycles

Timeline

• Start date: 2009-10-06
• Primary completion: 2011-08-23
• Completion: 2011-08-23
• First posted: 2009-07-24
• Last updated: 2021-04-08
• Results posted: 2020-11-18

Locations

3 sites across 1 country: United States