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CompletedPhase 3NCT00045162
Official study title

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

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedcisplatin and etoposide

Plus 1 other study approaches.

Who it may be forSmall cell lung cancer (SCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jul 31, 2018 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 3

Interventional

Where is it offered?408 U.S. locations

Locations may change over time.

Who runs it?SWOG Cancer Research Network

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 3
Sponsor
SWOG Cancer Research Network
Interventions being studied
Drug: cisplatin; Drug: etoposide; Drug: irinotecan hydrochloride
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Small cell lung cancer (SCLC)→
Treatment approach
Chemotherapy→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • DISEASE CHARACTERISTICS:
  • Histologically or cytologically confirmed extensive stage small cell lung cancer (SCLC)
  • Measurable or evaluable disease by CT scan, MRI, x-ray, physical exam, or nuclear exam
  • Brain metastases allowed if previously treated with radiotherapy and/or surgery and are neurologically stable (i.e., no progressing symptoms and off steroids and anticonvulsants) PATIENT CHARACTERISTICS: Age
  • 18 and over Performance status
  • Zubrod 0-1 Life expectancy
  • Not specified Hematopoietic
  • WBC at least 3,000/mm\^3
  • Absolute granulocyte count at least 1,500/mm\^3
  • Platelet count at least 100,000/mm\^3 Hepatic
  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • AST or ALT no greater than 2.5 times ULN Renal
  • Creatinine normal
  • Creatinine clearance at least 50 mL/min Other
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
  • HIV negative
  • No concurrent AIDS-related illness PRIOR CONCURRENT THERAPY: Biologic therapy
  • No prior biologic therapy for SCLC
  • No filgrastim (G-CSF) within 24 hours of chemotherapy Chemotherapy
  • No prior systemic chemotherapy for SCLC Endocrine therapy
  • See Disease Characteristics Radiotherapy
  • See Disease Characteristics
  • At least 21 days since prior brain radiotherapy and recovered
  • No other prior radiotherapy for SCLC Surgery
  • See Disease Characteristics
  • At least 21 days since prior thoracic or other major surgery and recovered Other
  • No concurrent enzyme inducing antiepileptic drugs (phenytoin, phenobarbital, oxcarboxepine, or carbamazepine)

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Northeast Alabama Regional Medical CenterAnniston, Alabama
  • Huntsville HospitalHuntsville, Alabama
  • Mobile Infirmary Medical CenterMobile, Alabama
  • East Alabama Medical CenterOpelika, Alabama
  • Alaska Regional Hospital Cancer CenterAnchorage, Alaska
  • Mayo Clinic ScottsdaleScottsdale, Arizona
  • Arizona Cancer Center at University of Arizona Health Sciences CenterTucson, Arizona
  • Hembree Mercy Cancer Center at St. Edward Mercy Medical CenterFort Smith, Arkansas
  • Arkansas Cancer Research Center at University of Arkansas for Medical SciencesLittle Rock, Arkansas
  • Providence Saint Joseph Medical Center - BurbankBurbank, California
  • Cancer Care Center at John Muir Health - Concord CampusConcord, California
  • Washington Township HospitalFremont, California

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 31, 2018. Always confirm current availability with the study team.

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