CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 50 enrolled
Drug / intervention
Carboplatin +1 moredrug
Likely dose
irinotecan hydrochloride 50 mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT00469898
NCT00469898Phase 2Completed

A Phase II Trial of Carboplatin and Irinotecan (CPT-11) as First-Line Therapy for Patients With Extensive Stage Small Cell Lung Cancer

Vanderbilt-Ingram Cancer Center·interventional·Posted May 7, 2007·Updated Jul 27, 2012

In Brief

A Phase 2 clinical trial evaluating Carboplatin and irinotecan hydrochloride for Lung Cancer. Completed, enrolled 50 participants across 8 sites in 2 countries.

Detailed Summary

RATIONALE: The general results of combining irinotecan and platin-based chemotherapies have been very encouraging. As the toxicity profile associated with carboplatin is preferable over cisplatin it is our expectation that patients and physicians would prefer to use this combination if it is equally or more efficacious. To date there has been no agreement regarding the optimal combination of these agents. Based on the trials described in the protocol and our experience with carboplatin/irinotecan in the treatment of non-small cell lung cancer the present trial will utilize a 21-day cycle of irinotecan 50 mg/m2 given on days 1 and 8 and carboplatin AUC 5 (based on the Calvert formula) on day 1. PURPOSE: This phase II trial is studying how well giving irinotecan together with carboplatin works as first-line therapy in treating patients with extensive-stage small cell lung cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLung Cancer
CountriesCanada, United States

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 7, 2007
Enrollment StartDec 1, 2003
Primary CompletionJul 1, 2008
Study CompletionJul 1, 2010
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 19.2 years ago

Interventions

Carboplatindrug

Carboplatin dosage calculation to be given on day 1, every 21 days: Carboplatin (mg) = (AUC of 5) x (GFR + 25) \*up to 6 cycles at physician's discretion

irinotecan hydrochloridedrug

50 mg/m2 IV on days 1 and 8 every 21 days Should be infused IV over 30- 90 minutes.