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CompletedPhase 2NCT00003281
Official study title

Topotecan and Paclitaxel in Treating Patients With Recurrent or Refractory 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. PURPOSE: Phase II trial to study the effectiveness of topotecan and paclitaxel in treating patients who have recurrent or refractory small cell lung cancer.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedpaclitaxel and topotecan hydrochloride

Plus 1 other study approaches.

Who it may be forSmall cell lung cancer (SCLC) · Recurrent or relapsed · Resistant or refractory

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
Drug: paclitaxel; Drug: topotecan hydrochloride; Radiation: radiation therapy
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)→
Disease setting
Recurrent or relapsed→Resistant or refractory→
Treatment approach
Chemotherapy→Radiation therapy→
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:
  • Stratum A (less than 3 months since prior therapy) closed to accrual effective 06/20/2000)
  • Histologically or cytologically confirmed recurrent or refractory small cell lung cancer
  • Only 1 prior regimen allowed (an alternating regimen with cyclophosphamide/doxorubicin/vincristine and etoposide/cisplatin is acceptable)
  • No mixed histology
  • Measurable or evaluable disease that has not been in the field of prior radiotherapy
  • No uncontrolled CNS metastases (treated CNS metastases eligible) PATIENT CHARACTERISTICS: Age:
  • 18 and over Performance status:
  • ECOG 0-2 Hematopoietic:
  • Absolute neutrophil count at least 2,000/mm\^3
  • Platelet count at least 100,000/mm\^3 Hepatic:
  • Total bilirubin no greater than 1.5 times upper limit of normal (ULN) OR
  • Direct bilirubin normal Renal:
  • Creatinine no greater than 1.5 times ULN Cardiovascular:
  • No unstable angina pectoris
  • No uncontrolled congestive heart failure
  • No myocardial infarction within the past 3 months Other:
  • No uncontrolled infections
  • No other concurrent malignancy except skin cancer or localized prostate cancer
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy:
  • Not specified Chemotherapy:
  • See Disease Characteristics
  • No prior topoisomerase I inhibitor (e.g., topotecan or irinotecan) or taxane (e.g., paclitaxel or docetaxel)
  • At least 3 months since other prior chemotherapy Radiotherapy:
  • See Disease Characteristics
  • At least 2 weeks since prior radiotherapy
  • No concurrent radiotherapy Surgery:
  • At least 3 weeks since any 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 - OchsnerNew Orleans, Louisiana
  • CCOP - DuluthDuluth, Minnesota
  • Mayo Clinic Cancer CenterRochester, Minnesota
  • CentraCare Health PlazaSaint Cloud, 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.

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