CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 14 enrolled
Drug / intervention
Paclitaxel +2 moredrug
Likely dose
Paclitaxel 150mgfrom 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/NCT00618826
NCT00618826Phase 2Completed
CompareCT.gov

A Phase II Trial of Biweekly Gemcitabine, Paclitaxel, and Avastin as Frontline Therapy for Metastatic Breast Cancer

Barbara Ann Karmanos Cancer Institute·interventional·Posted Feb 20, 2008·Updated Apr 14, 2017

In Brief

A Phase 2 clinical trial evaluating Paclitaxel, Gemcitabine, and 1 other intervention for Metastatic Breast Cancer. Completed, enrolled 14 participants across 1 site.

Detailed Summary

The purpose of this study is to look at a new chemotherapy schedule in metastatic breast cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Breast Cancer
CountriesUnited States
CollaboratorsEli Lilly and Company, Genentech, Inc.

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 20, 2008
Enrollment StartNov 1, 2006
Primary CompletionFeb 1, 2014
TodayJul 2, 2026
Enrollment to primary: 7.3 yearsPosted 18.4 years ago

Interventions

Paclitaxeldrug

Patients will be premedicated with dexamethasone and diphenhydramine hydrochloride. Patients will received 150mg of paclitaxel via IV over 120 mins.

Gemcitabinedrug

Patients will receive 1500mg of Gemcitabine via IV over 30-60 minutes. Gemcitabine will be given after Paclitaxel.

Avastindrug

10mg/kg will be given via IV over 90 mins (1st dose). Patients must remain under supervision for 1 hr after completion of the initial dose of Avastin. If no side effects occur, shortened, 60-min 2nd infusion, the post-infusion observation period for the subsequent infusions may be shortened to 20 minutes, and eliminated entirely with the fourth and subsequent infusions.