CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 30 enrolled
Drug / intervention
Intervention A: Irinotecan; Oxaliplatin; Neulasta +1 moredrug
Likely dose
Intervention A: Irinotecan 150–200 mg/m² IV day 1 every 5 weeks + Oxaliplatin 85 mg/m² IV day 1 every 5 weeks + Neulasta 6 mg SC day 1 every 5 weeks; Intervention B: Etoposide 100 mg/m² IV days 1–3 every 5 weeks + Carboplatin AUC 6 IV day 1 every 5 weeks + Neulasta 6 mg SC day 4 every 5 weeksAI-extracted
Key inclusion· 8
  • ✓Histologically or cytologically confirmed SCLC
  • ✓Measurable or assessable tumor parameters
  • ✓ECOG performance status 0–2
  • ✓Age 18–79 years (or >18 in Alabama)
Key exclusion· 9
  • ✕Symptomatic brain metastases
  • ✕Concurrent cancer chemotherapy, biologic therapy, or radiotherapy
  • ✕Peripheral neuropathy ≥Grade 2 at baseline
  • ✕Chronic diarrhea or >2–3 stools/day above normal in past 2 weeks

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

Search/NCT00240097
NCT00240097Phase 2Completed
CompareCT.gov

Study of Sequential Topoisomerase, Irinotecan/Oxaliplatin-Etoposide/Carboplatin in Extensive SCLC

University of Alabama at Birmingham·interventional·Posted Oct 17, 2005·Updated Nov 27, 2014

In Brief

A Phase 2 clinical trial evaluating Intervention A: Irinotecan; Oxaliplatin; Neulasta and Intervention B: Etoposide; Carboplatin; Neulasta for Non-Small Cell Lung Cancer. Completed, enrolled 30 participants across 1 site.

Detailed Summary

The primary objective of Part I of the study is to determine tumor response rate of sequential topoisomerase targeting with irinotecan/oxaliplatin followed by etoposide /carboplatin in chemotherapy-naïve patients with extensive small cell lung cancer. The primary objective of Part II of the study is to determine the objective tumor response rate of irinotecan/oxaliplatin in patients with either refractory disease or who have relapsed to first line chemotherapy or chemoradiotherapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-Small Cell Lung Cancer
CountriesUnited States
CollaboratorsSanofi-Synthelabo, Amgen

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 17, 2005
Enrollment StartJun 1, 2005
Primary CompletionJun 1, 2010
TodayJul 2, 2026
Enrollment to primary: 5 yearsPosted 20.7 years ago

Interventions

Intervention A: Irinotecan; Oxaliplatin; Neulastadrug

Irinotecan (I.V.) 150-200 mg/m2; Day 1 (every 5 weeks) Oxaliplatin (I.V.) 85 mg/m2; Day 1 (every 5 weeks) Neulasta (subcutaneous) 6 mg; Day 1 (every 5 weeks)

Intervention B: Etoposide; Carboplatin; Neulastadrug

Etoposide (I.V.) 100 mg/m2; Day 1, 2, 3 (every 5 weeks) Carboplatin (I.V.) AUC 6; Day 1 (every 5 weeks) Neulasta (subcutaneous) 6 mg; Day 4 (every 5 weeks)