CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 452 enrolled
Drug / intervention
Bevacizumab +6 morebiological
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/NCT00803062
NCT00803062Phase 3Completed

A Randomized Phase III Trial of Cisplatin Plus Paclitaxel With and Without NCI-Supplied Bevacizumab (NSC #704865) Versus the Non-platinum Doublet, Topotecan Plus Paclitaxel, With and Without NCI-Supplied Bevacizumab, in Stage IVB, Recurrent or Persistent Carcinoma of the Cervix

National Cancer Institute (NCI)·interventional·Posted Dec 5, 2008·Updated Jul 23, 2019

In Brief

A Phase 3 clinical trial evaluating Bevacizumab, Cisplatin, and 5 other interventions for Cervical Adenocarcinoma and 4 related conditions. Completed, enrolled 452 participants across 549 sites in 2 countries.

Detailed Summary

This randomized phase III trial studies the side effects of paclitaxel when given together with cisplatin or topotecan with or without bevacizumab and to compare how well they work in treating patients with stage IVB, cervical cancer that has come back or is persistent. Drugs used in chemotherapy, such as paclitaxel, cisplatin, and topotecan, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. It is not yet known whether paclitaxel is more effective when given together with cisplatin or topotecan with or without bevacizumab in treating patients with cervical cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSpain, United States
CollaboratorsNRG Oncology

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 5, 2008
Enrollment StartApr 1, 2009
Primary CompletionFeb 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 17.6 years ago

Interventions

Bevacizumabbiological

Given IV

Cisplatindrug

Given IV

Laboratory Biomarker Analysisother

Correlative studies

Paclitaxeldrug

Given IV

Quality-of-Life Assessmentother

Ancillary studies

Questionnaire Administrationother

Ancillary studies

Topotecan Hydrochloridedrug

Given IV