CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 75 enrolled
Drug / intervention
Docetaxel +3 moredrug
Likely dose
Docetaxel 30 mg/m² on days 1 and 8 of 21-day cycles (3 cycles); Gemcitabine 1000 mg/m² on days 1 and 8 of 21-day cycles (3 cycles); Carboplatin AUC 1.5 weekly × 7 weeks; followed by radiation to 63 GyAI-extracted
Key inclusion· 7
  • ✓Histologically confirmed non-small cell lung cancer
  • ✓Clinical stage IB, II, or select stage III disease
  • ✓Must be operable candidate
  • ✓Measurable or evaluable disease
Key exclusion· 3
  • ✕Stage IV disease
  • ✕Prior malignancy within 5 years
  • ✕Pregnant or breast-feeding

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

Search/NCT00193427
NCT00193427Phase 2Completed
CompareCT.gov

Phase II Trial of Preoperative (Neo-adjuvant) Therapy in Patients With Stages IB, II, IIIA, and Selected IIIB Patients With Non-Small Cell Lung Cancer

SCRI Development Innovations, LLC·interventional·Posted Sep 19, 2005·Updated Mar 3, 2022

In Brief

A Phase 2 clinical trial evaluating Docetaxel, Gemcitabine, and 2 other interventions for Lung Cancer. Completed, enrolled 75 participants across 1 site.

Detailed Summary

This trial is designed to study the role of docetaxel/gemcitabine, an active and relatively non-toxic combination in advanced NSCLC. This study will help to better define optimal preoperative regimens for patients with resectable NSCLC. Since both of these drugs are potent radio-sensitizers, the concurrent use with radiation therapy at these weekly doses may produce not only radio-sensitization, but also considerable antitumor efficacy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLung Cancer
CountriesUnited States
CollaboratorsAventis Pharmaceuticals, Eli Lilly and Company

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 19, 2005
Enrollment StartApr 1, 2004
Primary CompletionNov 1, 2008
Study CompletionDec 1, 2008
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 20.8 years ago

Interventions

Docetaxeldrug

30mg/m2 administered on days 1 and 8, 21-cycle days, 3 cycles

Gemcitabinedrug

1000 mg/m2 administered by 30-minute IV infusion on day 1 and 8, 21-cycle days, 3 cycles

Carboplatindrug

AUC = 1.5 weekly x 7

Radiationradiation

To 63 Gy