CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 9 enrolled
Drug / intervention
carboplatin +2 moredrug
Likely dose
Bevacizumab 15 mg/kgfrom 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/NCT01219777
NCT01219777Phase 1Completed
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Phase I Evaluation of Intravenous Carboplatin With Weekly Paclitaxel and Bevacizumab in Patients Undergoing Neoadjuvant Chemotherapy for Epithelial Ovarian, Fallopian Tube, and Primary Peritoneal Cancer

Ritu Salani·interventional·Posted Oct 13, 2010·Updated Feb 8, 2018

In Brief

A Phase 1 clinical trial evaluating carboplatin, Bevacizumab, and 1 other intervention for Ovarian Cancer and 2 related conditions. Completed, enrolled 9 participants across 1 site.

Detailed Summary

The purpose of this study is to determine the maximum tolerated dose (MTD) of intravenous weekly paclitaxel given with intravenous carboplatin and bevacizumab in patients with epithelial ovarian, primary peritoneal, or fallopian tube carcinoma that are to receive neoadjuvant chemotherapy (prior to surgical cytoreduction). Patients will then undergo surgery which will allow an objective measure of response to the above regimen as well as assessment of surgical outcomes.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOvarian Cancer, Primary Peritoneal Cancer, Fallopian Tube Cancer
CountriesUnited States
CollaboratorsGenentech, Inc.

Timeline

Phase 1CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedOct 13, 2010
Enrollment StartSep 1, 2010
Primary CompletionMay 1, 2012
Study CompletionMay 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 15.7 years ago

Interventions

carboplatindrug

Carboplatin AUC 5.0 or 6.0 will be administered on day 1 during cycle 1-3. Treatment cycle consists of 21 days duration.

Bevacizumabdrug

Bevacizumab 15 mg/kg administered on Day 1 during cycle 1-3. Treatment cycle consists of 21 days duration.

Paclitaxeldrug

60-80 mg/m2 administered on Day 1, 8 \& 15 during cycle 1-3. Treatment cycle consists of 21 days duration.