CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 66 enrolled
Drug / intervention
Cyclophosphamide +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00001426
NCT00001426Phase 2Completed

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

National Cancer Institute (NCI)·interventional·Posted Nov 4, 1999·Updated Apr 5, 2018

In Brief

A Phase 2 clinical trial evaluating Cyclophosphamide, Paclitaxel, and 2 other interventions for Ovarian Neoplasm. Completed, enrolled 66 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
199519961997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 4, 1999
Enrollment StartFeb 3, 1995
Primary CompletionOct 15, 2007
Study CompletionNov 7, 2013
TodayJul 2, 2026
Enrollment to primary: 12.7 yearsPosted 26.7 years ago

Interventions

Cyclophosphamidedrug

Paclitaxeldrug

Cisplatindrug

G-CSFdrug