CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 38 enrolled
Drug / intervention
bevacizumab +3 morebiological
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/NCT01344824
NCT01344824Phase 2Completed

A Multicenter Phase II Trial of Carboplatin, Pemetrexed, and Bevacizumab Followed By Pemetrexed and Bevacizumab Maintenance Therapy in Patients With a Light or Never Smoking History

UNC Lineberger Comprehensive Cancer Center·interventional·Posted Apr 29, 2011·Updated Oct 30, 2017

In Brief

A Phase 2 clinical trial evaluating bevacizumab, carboplatin, and 2 other interventions for Lung Cancer. Completed, enrolled 38 participants across 4 sites.

Detailed Summary

RATIONALE: Drugs used in chemotherapy, such as carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Pemetrexed disodium may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of non-small cell lung cancer by blocking blood flow to the tumor. Giving carboplatin and pemetrexed disodium together with bevacizumab may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving carboplatin and pemetrexed disodium together with bevacizumab works in treating patients with stage III or stage IV non-small cell lung cancer who are light or never smokers.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLung Cancer
CountriesUnited States

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 29, 2011
Enrollment StartMar 1, 2010
Primary CompletionMay 24, 2016
Study CompletionJul 20, 2016
TodayJul 2, 2026
Enrollment to primary: 6.2 yearsPosted 15.2 years ago

Interventions

bevacizumabbiological

15 mg/kg once per 21 day cycle (up to 4 cycles).

carboplatindrug

Area Under the Curve (AUC)=6, once every 21 day cycle (up to 4 cycles)

erlotinib hydrochloridedrug

150mg, daily for 21 day cycle (up to 4 cycles)

pemetrexed disodiumdrug

500 mg/m2 on day 1 of a 21 day cycle (up to 4 cycles)