CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 45 enrolled
Drug / intervention
cisplatin +7 moredrug
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/NCT01557959
NCT01557959Phase 2Completed

Phase II Study of Sequential Dose-Dense Chemotherapy and Dose-Intense Erlotinib for the Initial Treatment of Advanced Non-Small Cell Lung Cancer

Wake Forest University Health Sciences·interventional·Posted Mar 20, 2012·Updated Jun 29, 2018

In Brief

A Phase 2 clinical trial evaluating cisplatin, pegfilgrastim, and 6 other interventions for Adenocarcinoma of the Lung and 8 related conditions. Completed, enrolled 45 participants across 1 site.

Detailed Summary

This phase II trial is studying how well docetaxel given together with cisplatin and pegfilgrastim followed by erlotinib hydrochloride works in treating patients with stage IIIB or stage IV non-small cell lung cancer. Drugs used in chemotherapy, such as docetaxel and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Colony stimulating factors, such as pegfilgrastim, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving dose-dense combination chemotherapy together with pegfilgrastim and erlotinib hydrochloride may kill more tumor cells

Study Details

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 20, 2012
Enrollment StartJul 1, 2007
Primary CompletionFeb 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 14.3 years ago

Interventions

cisplatindrug

Given IV

pegfilgrastimbiological

Given SC

erlotinib hydrochloridedrug

Given PO

laboratory biomarker analysisother

Optional correlative study

polymorphism analysisgenetic

Correlative study

pharmacogenomic studiesother

Correlative study

genetic linkage analysisgenetic

Correlative study

docetaxeldrug

Given IV