CompletedPhase 2NCT00004055
Official study title

Topotecan, Paclitaxel, and 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 study the effectiveness of topotecan, paclitaxel, and filgrastim in treating patients who have previously untreated extensive-stage small cell lung cancer.

Ask AI to explain this study
Start here

Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedfilgrastim and paclitaxel

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 13, 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?19 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: paclitaxel; Drug: topotecan hydrochloride
02
Explore related studies

How this study is categorized

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

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 previously untreated small cell lung cancer No mixed histology Extensive disease Metastatic disease outside the chest Contralateral supraclavicular nodes or contralateral hilar nodes outside a single radiation port OR Cytologically proven malignant pleural effusion Measurable or evaluable disease No untreated CNS metastases CNS metastases previously treated with whole brain radiotherapy allowed PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: AST no greater than 5 times upper limit of normal (ULN) Alkaline phosphatase no greater than 5 times ULN Total bilirubin no greater than 1.5 times ULN OR Direct bilirubin normal Renal: Creatinine no greater than 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 greater than 40% No uncontrolled arrhythmias No myocardial infarction within the past 3 months Other: No significant infection No hypersensitivity to E. coli derivatives No other malignancy within the past 3 years except nonmelanoma skin cancer, carcinoma in situ of the cervix, or localized prostate cancer Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 10 years since prior chemotherapy No prior nitrosourea based chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 10 years since prior thoracic radiotherapy No more than 3 fractions of prior thoracic radiotherapy for superior vena cava syndrome Prior palliative radiotherapy except to the chest allowed No prior radiotherapy to at least 20% bone marrow No concurrent radiotherapy (including thoracic), except whole brain radiotherapy for CNS progression Surgery: At least 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
  • 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
  • CCOP - DuluthDuluth, Minnesota
  • Mayo Clinic Cancer CenterRochester, Minnesota
  • CentraCare ClinicSaint Cloud, Minnesota
  • CCOP - Metro-MinnesotaSaint Louis Park, Minnesota
  • CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 13, 2016. Always confirm current availability with the study team.

View original record ↗