CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 671 enrolled
Drug / intervention
cisplatin +2 moredrug
Likely dose
Cisplatin 60-80 mg/m² IV on Day 1 every 4 weeks x4 cycles, plus either irinotecan 60 mg/m² IV on Days 1, 8, 15 every 4 weeks x4 cycles OR etoposide 100 mg/m² IV on Days 1-3 every 3 weeks x4 cyclesAI-extracted
Key inclusion· 9
  • ✓Histologically or cytologically confirmed extensive stage small cell lung cancer (SCLC)
  • ✓Measurable or evaluable disease by imaging or physical exam
  • ✓Age 18 years or older
  • ✓Zubrod performance status 0-1
Key exclusion· 6
  • ✕Prior systemic chemotherapy for SCLC
  • ✕Prior biologic therapy for SCLC
  • ✕Other malignancy within past 5 years except skin cancer or cervical carcinoma in situ
  • ✕Concurrent AIDS-related illness

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

Search/NCT00045162
NCT00045162Phase 3Completed
CompareCT.gov

Randomized Phase III Trial of Cisplatin and Irinotecan (NSC-616348) Versus Cisplatin and Etoposide in Patients With Extensive Stage Small Cell Lung Cancer (E-SCLC)

SWOG Cancer Research Network·interventional·Posted Jan 27, 2003·Updated Jul 31, 2018

In Brief

A Phase 3 clinical trial evaluating cisplatin, etoposide, and 1 other intervention for Lung Cancer. Completed, enrolled 671 participants across 408 sites in 2 countries.

Detailed Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known whether cisplatin combined with irinotecan is more effective than cisplatin combined with etoposide in treating extensive-stage small cell lung cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of cisplatin combined with either irinotecan or etoposide in treating patients who have extensive-stage small cell lung cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLung Cancer
CountriesCanada, United States
CollaboratorsNational Cancer Institute (NCI), North Central Cancer Treatment Group, Cancer and Leukemia Group B

Timeline

Phase 3CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 27, 2003
Enrollment StartNov 1, 2002
Primary CompletionMar 1, 2008
Study CompletionDec 1, 2009
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 23.4 years ago

Interventions

cisplatindrug

Arm 1: 60 mg/m2 IV (over 30-60 min) on Day 1, Q 4 weeks x 4 Cycles Arm 2: 80 mg/m2 IV (over 30-60 min) on Day 1, Q 4 weeks x 4 Cycles

etoposidedrug

100 mg/m2 IV (over 30-60 min) on Days 1 , 2 \& 3. Q 3 weeks x 4 Cycles

irinotecan hydrochloridedrug

60 mg/m2 IV (over 90 min)on Days 1, 8 \& 15. Q 4 weeks x 4 Cycles