CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 50 enrolled
Drug / intervention
Oral Hycamtin (topotecan) Capsules + IV Avastin (bevacizumab)drug
Likely dose
Oral Hycamtin (topotecan) Capsules + IV Avastin (bevacizumab) 2.3 mg/m2from 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/NCT00698516
NCT00698516Phase 2Completed
CompareCT.gov

An Open-label, Multicenter, Non-comparative, Phase II Study of Oral Topotecan in Combination With Bevacizumab for Second-line Treatment in Subjects With Relapsed Small-cell Lung Cancer (SCLC)

GlaxoSmithKline·interventional·Posted Jun 17, 2008·Updated Mar 27, 2012

In Brief

A Phase 2 clinical trial evaluating Oral Hycamtin (topotecan) Capsules + IV Avastin (bevacizumab) for Recurrent Small-cell Lung Cancer (SCLC) and Lung Cancer, Small Cell. Completed, enrolled 50 participants across 16 sites.

Detailed Summary

Combination of Hycamtin (topotecan) and Avastin (bevacizumab) could allow killing of both endothelial and neoplastic cells. We postulate that addition of bevacizumab to topotecan will increase delivery of topotecan to tumor cells and may enhance activity of topotecan in patients with previously treated small cell lung cancer and improve progression free survival.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRecurrent Small-cell Lung Cancer (SCLC), Lung Cancer, Small Cell
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 17, 2008
Enrollment StartJul 1, 2008
Primary CompletionMay 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 18.0 years ago

Interventions

Oral Hycamtin (topotecan) Capsules + IV Avastin (bevacizumab)drug

2.3 mg/m2 daily x 5 oral topotecan and 15 mg/kg IV bevacizumab on day 1 of every 21 days cycle.