CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 612 enrolled
Drug / intervention
bexarotene with carboplatin and paclitaxel +1 moredrug
Likely dose
Bexarotene 400 mg/m²/day with carboplatin AUC 6 IV every 3 weeks and paclitaxel 200 mg/m² IV every 3 weeksAI-extracted
Key inclusion· 5
  • Pathologically confirmed (histologic or cytologic) NSCLC
  • Stage IIIB with malignant pleural effusion or Stage IV disease
  • At least one measurable or evaluable NSCLC lesion (not previously irradiated, or if irradiated >3 weeks prior with documented progression)
  • Adequate organ system function
Key exclusion· 3
  • Brain metastasis
  • Prior chemotherapy for NSCLC
  • Prior platinum-based chemotherapy for any indication

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

Search/NCT00050960
NCT00050960Phase 3Completed

Randomized Phase III Trial Comparing Targretin Capsules/Carboplatin/Paclitaxel Versus Carboplatin/Paclitaxel in Chemotherapy-Naïve Patients With Advanced or Metastatic Non-Small Cell Lung Cancer

Eisai Inc.·interventional·Posted Jan 3, 2003·Updated Jul 13, 2012

In Brief

A Phase 3 clinical trial evaluating bexarotene with carboplatin and paclitaxel and carboplatin and paclitaxel for Non-small Cell Lung Cancer. Completed, enrolled 612 participants across 154 sites in 6 countries.

Detailed Summary

This study evaluates the use of Targretin capsules (bexarotene) in combination with standard chemotherapy for the treatment of metastatic Non-Small Cell Lung Cancer (NSCLC) in patients who have not yet received chemotherapy for their lung cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustria, Canada, France, Germany, Spain, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 3, 2003
Enrollment StartMay 1, 2002
Primary CompletionJul 1, 2004
Study CompletionMar 1, 2005
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 23.5 years ago

Interventions

bexarotene with carboplatin and paclitaxeldrug

bexarotene capsules (400 mg/m\^2/day) in combination with carboplatin IV (AUC 6) every 3 weeks and paclitaxel IV (200 mg/m\^2) every 3 weeks. Subjects in this group also received an antilipid agent which was selected at the discretion of the investigator.

carboplatin and paclitaxeldrug

carboplatin IV (AUC 6) every 3 weeks and paclitaxel IV (200 mg/m\^2) every 3 weeks.