CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 52 enrolled
Drug / intervention
bortezomib +3 moredrug
Likely dose
Bortezomib IV in combination with paclitaxel IV, carboplatin IV, and concurrent 3-dimensional conformal radiation therapyAI-extracted
Key inclusion· 8
  • Histologically or cytologically confirmed NSCLC
  • Locally advanced stage IIIA or IIIB disease that is unresectable
  • No stage IV disease
  • Requires radiotherapy
Key exclusion· 7
  • No prior systemic chemotherapy for NSCLC
  • No prior radiotherapy to the chest
  • No peripheral neuropathy ≥grade 2
  • No uncontrolled infection

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

Search/NCT00093756
NCT00093756Phase 2Completed

Phase I/II Study of PS-341 in Combination With Paclitaxel, Carboplatin, and Concurrent Thoracic Radiation Therapy for Non-small Cell Lung Cancer (NSCLC)

National Cancer Institute (NCI)·interventional·Posted Oct 8, 2004·Updated Dec 7, 2017

In Brief

A Phase 2 clinical trial evaluating 3-dimensional conformal radiation therapy, bortezomib, and 2 other interventions for Recurrent Non-small Cell Lung Cancer and 2 related conditions. Completed, enrolled 52 participants across 143 sites.

Detailed Summary

This phase I/II trial (phase I closed to accrual as of 09/29/2009) is studying the side effects and best dose of bortezomib, paclitaxel, and carboplatin when given with radiation therapy and to see how well they work in treating patients with stage IIIA or stage IIIB non-small cell lung cancer that cannot be removed by surgery. Bortezomib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Bortezomib may increase the effectiveness of paclitaxel and carboplatin by making tumor cells more sensitive to the drugs. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving bortezomib, paclitaxel, and carboplatin together with radiation therapy may kill more tumor cells.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 8, 2004
Enrollment StartSep 1, 2004
Primary CompletionJan 1, 2012
Study CompletionMay 1, 2013
TodayJul 2, 2026
Enrollment to primary: 7.3 yearsPosted 21.7 years ago

Interventions

3-dimensional conformal radiation therapyradiation

bortezomibdrug

Given IV

paclitaxeldrug

Given IV

carboplatindrug

Given IV