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S0124: Cisplatin Combined With Irinotecan or Etoposide For Extensive-Stage Small Cell Lung Cancer

NCT00045162 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 671

Last updated 2018-07-31

Study results available
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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.

Conditions

Interventions

DRUG

cisplatin

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

DRUG

etoposide

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

DRUG

irinotecan hydrochloride

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

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • North Central Cancer Treatment Group

    collaborator NETWORK

  • Cancer and Leukemia Group B

    collaborator NETWORK

  • SWOG Cancer Research Network

    lead NETWORK

Principal Investigators

  • Ronald B. Natale, MD · Cedars-Sinai Medical Center

  • David R. Gandara, MD · University of California, Davis

  • Primo N. Lara, MD · University of California, Davis

  • James R. Jett, MD · Mayo Clinic

  • Jane Carleton, MD · Don Monti Comprehensive Cancer Center at North Shore University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-11-30
Primary Completion
2008-03-31
Completion
2009-12-31

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00045162 on ClinicalTrials.gov