CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 58 enrolled
Drug / intervention
docetaxel +3 moredrug
Likely dose
docetaxel 25 mgfrom 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/NCT00436501
NCT00436501Phase 2Completed

Phase I/II and Pharmacokinetic Study of Docetaxel Plus VEGF Trap (AVE0005, NSC# 724770) in Patients With Recurrent Ovarian, Primary Peritoneal, and Fallopian Tube Cancer

National Cancer Institute (NCI)·interventional·Posted Feb 19, 2007·Updated Feb 26, 2019

In Brief

A Phase 2 clinical trial evaluating docetaxel, ziv-aflibercept, and 2 other interventions for Fallopian Tube Cancer and 2 related conditions. Completed, enrolled 58 participants across 2 sites.

Detailed Summary

This phase I/II trial is studying the side effects and best dose of VEGF Trap when given together with docetaxel and to see how well they work in treating patients with persistent or recurrent ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer. VEGF Trap may stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving VEGF Trap together with docetaxel may kill more tumor cells

Study Details

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

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 19, 2007
Enrollment StartJan 1, 2007
Primary CompletionMar 1, 2011
Study CompletionNov 1, 2012
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 19.4 years ago

Interventions

docetaxeldrug

25 mg/m\^2 given intravenously (IV) over 1 hour (+/- 10 minutes) following VEGF Trap every 3 weeks starting cycle 1 (21 day cycles)

ziv-afliberceptbiological

Starting dose 2 mg/kg given IV Cycle 0. Phase I Group: Every 3 weeks beginning with Cycle 0 (Completed 03/14/2008); Phase II Group: Every 3 weeks starting cycle 1 (Opened 05/09/2008).

laboratory biomarker analysisother

Correlative studies

pharmacological studyother

Correlative studies