NCT00001426

A Multi-Institutional Phase II Study of Cyclophosphamide, Paclitaxel, Cisplatin With G-CSF for Patients With Newly Diagnosed Advanced Stage Ovarian Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

A supra-additive cytotoxic effect was seen when CAI and paclitaxel were given to human ovarian cancer cells sequentially in tissue culture. We have demonstrated that CAI given for 8 days followed by paclitaxel is reasonably well tolerated and that paclitaxel administration causes a dose-dependent increase in CAI plasma concentration. CAI is a cytostatic drug and continuous exposure is needed. This study will evaluate the combination of continuously administered CAI with three-weekly paclitaxel.

Detailed description

A supra-additive cytotoxic effect was seen when CAI and paclitaxel were given to human ovarian cancer cells sequentially in tissue culture. We have demonstrated that CAI given for 8 days followed by paclitaxel is reasonably well tolerated and that paclitaxel administration causes a dose-dependent increase in CAI plasma concentration. CAI is a cytostatic drug and continuous exposure is needed. This study will evaluate the combination of continuously administered CAI with three-weekly paclitaxel.

Conditions

• Ovarian Neoplasm

Interventions

Type	Name	Description
DRUG	Cyclophosphamide
DRUG	Paclitaxel
DRUG	Cisplatin
DRUG	G-CSF

Timeline

• Start date: 1995-02-03
• Primary completion: 2007-10-15
• Completion: 2013-11-07
• First posted: 1999-11-04
• Last updated: 2018-04-05

Locations

1 site across 1 country: United States