CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 86 enrolled
Drug / intervention
Carboplatin +3 moredrug
Likely dose
Erlotinib 150 mg or 1500 mg (two doses being compared) followed by carboplatin and paclitaxel 200 mg/m²AI-extracted
Key inclusion· 6
  • Pathologically confirmed non-small cell lung cancer
  • Stage IIIB, IV, or recurrent disease
  • Measurable or evaluable indicator lesions
  • History of smoking ≥100 cigarettes in lifetime
Key exclusion· 6
  • No prior chemotherapy for advanced NSCLC
  • No prior EGFR/HER-directed agents (gefitinib, cetuximab, trastuzumab)
  • No gastrointestinal tract disease or inability to take oral medication
  • No prior malignancy within 2 years except nonmelanoma skin cancer or cervical carcinoma in situ

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

Search/NCT00287989
NCT00287989Phase 2Completed

A Randomized Phase II Trial Comparing Two Doses of Pulsed Erlotinib Prechemotherapy (PEP-C) in Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins·interventional·Posted Feb 7, 2006·Updated Dec 6, 2018

In Brief

A Phase 2 clinical trial evaluating Carboplatin, erlotinib hydrochloride, and 1 other intervention for Lung Cancer. Completed, enrolled 86 participants across 2 sites.

Detailed Summary

RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving erlotinib together with paclitaxel and carboplatin may kill more tumor cells. PURPOSE: This randomized phase II trial is studying two different doses of erlotinib when given together with paclitaxel and carboplatin to compare how well they work in treating patients with stage III, stage IV, or recurrent non-small cell lung cancer.

Study Details

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

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 7, 2006
Enrollment StartNov 1, 2004
Primary CompletionAug 1, 2007
Study CompletionMay 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 20.4 years ago

Interventions

Carboplatindrug

erlotinib hydrochloridedrug

150mg

Paclitaxeldrug

200mg/m2

erlotinib hydrochloridedrug

1500mg