CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 112 enrolled
Drug / intervention
Docetaxel/Carboplatin/Bevacizumab/Erlotinib +1 moredrug
Likely dose
Docetaxel/Carboplatin/Bevacizumab/Erlotinib 75mg/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/NCT00621049
NCT00621049Phase 2Completed

Randomized Phase II Trial of Adjuvant Carboplatin, Docetaxel, Bevacizumab, and Erlotinib Versus Chemotherapy Alone in Patients With Resected Non-Small Cell Lung Cancer

SCRI Development Innovations, LLC·interventional·Posted Feb 22, 2008·Updated Jun 8, 2015

In Brief

A Phase 2 clinical trial evaluating Docetaxel/Carboplatin/Bevacizumab/Erlotinib and Docetaxel/Carboplatin for Non-Small Cell Lung Cancer. Completed, enrolled 112 participants across 26 sites.

Detailed Summary

Multicenter randomized phase II trial to examine the safety and efficacy of carboplatin, docetaxel, bevacizumab followed by maintenance bevacizumab and erlotinib in patients with completely resected stage IB, II, and select III NSCLC.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsGenentech, Inc., Sanofi

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 22, 2008
Enrollment StartDec 1, 2007
Primary CompletionJul 1, 2013
Study CompletionFeb 1, 2014
TodayJul 2, 2026
Enrollment to primary: 5.6 yearsPosted 18.4 years ago

Interventions

Docetaxel/Carboplatin/Bevacizumab/Erlotinibdrug

Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1 Bevacizumab 15mg/kg IV D1 Docetaxel should be administered before carboplatin. After completion of four cycles of treatment, patients in Cohort A will then proceed with Maintenance treatment defined as follows: Maintenance Treatment for patients in Cohort A: Bevacizumab 15mg/kg IV D1 Erlotinib 150mg PO daily Treatment cycle = 21 days. Patients will complete 8 cycles (24 weeks) of maintenance therapy unless there is evidence of disease recurrence or unacceptable toxicity.

Docetaxel/Carboplatindrug

Adjuvant Treatment Cohort B: Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1 Docetaxel should be administered before carboplatin. Treatment cycle = 21 days. Patients in Cohort B will complete 4 cycles of treatment.