CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 41 enrolled
Drug / intervention
Paclitaxel +1 moredrug
Likely dose
Paclitaxel infusion on Mondays, Wednesdays, and Fridays with thoracic radiation in late afternoon after 4:00 PMAI-extracted
Key inclusion· 8
  • Histologically confirmed non-small-cell lung cancer
  • Inoperable stage I–II or unresectable stage IIIA–IIIB disease per AJCC 1998 criteria
  • Primary tumor must be radiographically measurable
  • Age >18
Key exclusion· 4
  • Small cell carcinoma or mesothelioma
  • Medical contraindication to chemotherapy or radiotherapy
  • Myocardial infarction within preceding 6 months or symptomatic heart disease (uncontrolled/unstable angina, congestive heart failure, arrhythmia)
  • Pregnant women

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

Search/NCT00178256
NCT00178256Phase 2Completed

A Phase I/II Clinical Trial Of Pulsed Paclitaxel And Daily Thoracic Radiotherapy For Inoperable (Stage I/II) Or Unresectable (Stage III) Lung Cancers

University of Rochester·interventional·Posted Sep 15, 2005·Updated Aug 21, 2015

In Brief

A Phase 2 clinical trial evaluating Paclitaxel and Radiation Therapy for Carcinoma, Non-Small-Cell Lung. Completed, enrolled 41 participants across 1 site.

Detailed Summary

A treatment study is being conducted by the University of Rochester Cancer Center (URCC) in which patients with non-small cell lung cancer will be treated with radiation therapy and a drug called paclitaxel. Paclitaxel is a natural product with anticancer properties. The first purpose of this study is to determine the dose of paclitaxel which, when given in combination with radiation therapy, will provide the greatest effect have the least side effects. To determine this, patients will be put on the study in groups of 3. The dose for each additional group will be higher than the previous dose until the maximum tolerated dose is reached. The second purpose is to determine if radiation therapy with paclitaxel is more effective in treating lung cancer than radiation therapy alone.

Study Details

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

Timeline

Phase 2CompletedFinished
199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 15, 2005
Enrollment StartJun 1, 1998
Primary CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 14.5 yearsPosted 20.8 years ago

Interventions

Paclitaxeldrug

On Mondays, Wednesdays, and Fridays, paclitaxel infusion will begin early in the morning and complete before 10:30 am.

Radiation Therapyprocedure

Thoracic XRT will be given in late afternoon, after 4:00 PM, if possible