At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 399 enrolled

Drug / intervention

Topotecan/Docetaxel combination +1 moredrug

Likely dose

Weekly IV topotecan/docetaxel combination or docetaxel (specific doses not stated in eligibility/arms)AI-extracted

Key inclusion· 9

✓Confirmed advanced non-small cell lung carcinoma (NSCLC)
✓Received exactly one prior chemotherapy for metastatic NSCLC (excluding topotecan/HYCAMTIN or docetaxel/TAXOTERE)
✓Prior non-cytotoxic therapy (EGFR or angiogenesis inhibitor) is allowed
✓Measurable or non-measurable disease by imaging or physical exam

Key exclusion· 9

✕Concomitant or prior malignancy within 5 years
✕Symptomatic brain metastases requiring steroid treatment
✕Active infection
✕Severe comorbid medical conditions limiting ability to follow protocol

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00065182

NCT00065182Phase 2Completed

Compare CT.gov

WEEKLY IV TOPOTECAN/DOCETAXEL COMBINATION COMPARED TO DOCETAXEL IN PATIENTS WITH PRETREATED ADVANCED NSCLC: AN OPEN-LABEL MULTICENTER RANDOMIZED PHASE III TRIAL

GlaxoSmithKline·interventional·Posted Jul 18, 2003·Updated Jun 24, 2019

In Brief

A Phase 2 clinical trial evaluating Topotecan/Docetaxel combination and Docetaxel for Lung Cancer, Non-Small Cell and Non-Small-Cell Lung Cancer. Completed, enrolled 399 participants across 85 sites in 3 countries.

Detailed Summary

The purpose of this study is to compare the efficacy and safety of a weekly regimen of two FDA approved drugs in combination versus one FDA approved drug in subjects with advanced non-small cell lung cancer who have received one previous chemotherapy excluding TAXOTERE or HYCAMTIN.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsLung Cancer, Non-Small Cell, Non-Small-Cell Lung Cancer

CountriesCanada, Poland, United States

Collaborators--

Timeline

Phase 2CompletedFinished

2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

First PostedJul 2003

Enrollment StartAug 2003

Primary CompletionAug 2007

TodayJul 2026

First PostedJul 18, 2003

Enrollment StartAug 14, 2003

Primary CompletionAug 30, 2007

TodayJul 2, 2026

Enrollment to primary: 4.0 yearsPosted 23.0 years ago

Interventions

Topotecan/Docetaxel combinationdrug

Docetaxeldrug