NCT00989131

Study of Paclitaxel in Patients With Ovarian Cancer

An Open, Randomized, Multicenter Study in Patients With Recurrent Epithelian Cancer, Primary Peritoneal Cancer or Fallopian Tube Cancer to Compare the Efficay and Safety of Paclitaxel (Micellar) Nanoparticles and Paclitaxel (Cremophor® EL)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 789 (actual)
• Sponsor: Oasmia Pharmaceutical AB · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Paclitaxel is one of the most widely used human anticancer agents. Paclitaxel has a low degree of solubility and Cremophor EL is typically used as the solubiliser. Cremophor EL is known to cause hypersensitivity reactions that can be life-threatening. As Paclical® does not contain Cremophor EL, hypersensitivity reactions can be expected to be less. PURPOSE: To study the efficay and safety of two different formulations of paclitaxel, Paclical® and Taxol®.

Conditions

• Epithelial Ovarian Cancer
• Primary Peritoneal Cancer
• Fallopian Tube Cancer

Interventions

Type	Name	Description
DRUG	Paclical®	250 mg/m2 of Paclical® is given as a one-hour IV infusion, followed by carboplatin, on day 1 of each 21 day cycle. Number of Cycles: 6. Cycle 2-6 will be given with 3 weeks interval between treatments.
DRUG	Taxol®	175 mg/m2 of Taxol® is given as 3 hour IV infusion, followed by carboplatin on day 1 of each 21 day cycle. Number of Cycles: 6. Cycle 2-6 will be given with 3 weeks interval between treatments.

Timeline

• Start date: 2009-02-01
• Primary completion: 2013-10-01
• Completion: 2013-10-01
• First posted: 2009-10-02
• Last updated: 2014-02-04

Locations

84 sites across 16 countries: Belarus, Belgium, Bulgaria, Croatia, Czechia, Denmark, Finland, Hungary, Latvia, Lithuania, Romania, Russia, Serbia, Slovakia, Sweden, Ukraine