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CompletedPhase 2NCT00028925
Official study title

Combination Chemotherapy With or Without Filgrastim in Treating Patients With Previously Untreated 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. Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. PURPOSE: Phase II trial to compare the effectiveness of combination chemotherapy with or without filgrastim in treating patients who have extensive-stage small cell lung cancer that has not been previously treated.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedfilgrastim and carboplatin

Plus 2 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 Dec 7, 2016 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?24 U.S. locations

Locations may change over time.

Who runs it?Alliance for Clinical Trials in Oncology

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
Alliance for Clinical Trials in Oncology
Interventions being studied
Biological: filgrastim; Drug: carboplatin; Drug: topotecan hydrochloride; Radiation: WBRT
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→
Study topics
After prior treatment→
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
  • Previously untreated with chemotherapy
  • No mixed histology
  • Metastatic disease outside the chest
  • Contralateral supraclavicular or hilar nodes that cannot be included in a single radiation port OR
  • Cytologically proven malignant pleural effusion
  • Measurable disease
  • No untreated CNS metastases
  • CNS metastases treated with whole-brain radiotherapy (WBRT) allowed after completion of WBRT PATIENT CHARACTERISTICS: Age:
  • 18 and over Performance status:
  • ECOG 0-2 Life expectancy:
  • Not specified Hematopoietic:
  • Absolute neutrophil count at least 1,500/mm\^3
  • Platelet count at least 100,000/mm\^3 Hepatic:
  • AST no greater than 5 times upper limit of normal (ULN)
  • Alkaline phosphatase no greater than 5 times ULN
  • Bilirubin no greater than 1.5 times ULN OR
  • Direct bilirubin no greater than ULN Renal:
  • Creatinine no greater than 1.5 times ULN OR
  • Creatinine clearance at least 50 mL/min Cardiovascular:
  • No uncontrolled angina pectoris
  • No congestive heart failure within the past 3 months unless ejection fraction is greater than 40%
  • No uncontrolled cardiac arrhythmias
  • No myocardial infarction within the past 3 months Other:
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No clinically significant infection
  • No hypersensitivity to E. coli-derived proteins
  • No other malignancy within the past 3 years except non-melanoma skin cancer, carcinoma in situ of the cervix, or localized prostate cancer PRIOR CONCURRENT THERAPY: Biologic therapy:
  • Not specified Chemotherapy:
  • See Disease Characteristics
  • At least 5 years since prior chemotherapy for another malignancy
  • No prior nitrosoureas Endocrine therapy:
  • Not specified Radiotherapy:
  • See Disease Characteristics
  • No prior thoracic radiotherapy
  • At least 1 day since prior palliative radiotherapy (except to chest)
  • No more than 3 fractions to chest for superior vena cava syndrome allowed
  • No concurrent radiotherapy (including thoracic radiotherapy) Surgery:
  • More than 3 weeks since prior major surgery

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

  • CCOP - Scottsdale Oncology ProgramScottsdale, Arizona
  • MBCCOP-Howard University Cancer CenterWashington D.C., District of Columbia
  • Mayo ClinicJacksonville, Florida
  • CCOP - Illinois Oncology Research AssociationPeoria, Illinois
  • CCOP - Carle Cancer CenterUrbana, Illinois
  • CCOP - Cedar Rapids Oncology ProjectCedar Rapids, Iowa
  • CCOP - Iowa Oncology Research AssociationDes Moines, Iowa
  • Siouxland Hematology-OncologySioux City, Iowa
  • CCOP - WichitaWichita, Kansas
  • Wichita Community Clinical Oncology ProgramWichita, Kansas
  • CCOP - OchsnerNew Orleans, Louisiana
  • CCOP - Ann Arbor RegionalAnn Arbor, Michigan

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Dec 7, 2016. Always confirm current availability with the study team.

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