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TerminatedPhase 2NCT00087048
Official study title

Topotecan in Treating Patients With Recurrent Extensive-Stage Small Cell Lung Cancer

Study summary

RATIONALE: Drugs used in chemotherapy, such as topotecan, work in different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: This phase II trial is studying how well high-dose topotecan works as second-line therapy in treating patients with recurrent 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 studiedtopotecan hydrochloride

The study team can explain what participation involves.

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

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Mar 22, 2016 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?2 U.S. locations

Locations may change over time.

Who runs it?Case Comprehensive Cancer Center

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
Case Comprehensive Cancer Center
Interventions being studied
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.

Cancer type
Small cell lung cancer (SCLC)→
Disease setting
Recurrent or relapsed→
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 confirmed small cell lung cancer (SCLC)
  • Recurrent extensive stage disease
  • No mixed histology
  • Measurable disease
  • At least 1 bidimensionally measurable, non-central nervous system (CNS), indicator lesion confirmed by CT scan or MRI
  • Sensitive disease
  • Responded to prior first-line therapy AND relapsed ≥ 60 days after response (90 days after initiation of first-line therapy)
  • Eligible for high-dose chemotherapy
  • No symptomatic brain metastases affecting performance status PATIENT CHARACTERISTICS: Age
  • 18 and over Performance status
  • Eastern Cooperative Oncology Group (ECOG) 0-2 Life expectancy
  • At least 2 months Hematopoietic
  • Absolute neutrophil count ≥ 1,500/mm\^3
  • Platelet count ≥ 100,000/mm\^3
  • Hemoglobin ≥ 9.0 g/dL
  • Hematocrit \> 35% (without transfusion) Hepatic
  • Serum glutamic-oxaloacetic transaminase (SGOT) and serum glutamate pyruvate transaminase (SGPT) ≤ 2 times normal\
  • Alkaline phosphatase ≤ 2 times normal\
  • Bilirubin ≤ 2.0 mg/dL
  • Albumin \> 2.5 g/dL
  • Hepatitis B surface antigen negative
  • No significant hepatic disease Note: \*≤ 5 times upper limit of normal if liver metastases are present Renal
  • Creatinine clearance ≥ 40 mL/min Cardiovascular
  • No history of cardiac arrhythmias
  • No congestive heart failure
  • No ischemic heart disease
  • No stroke or other embolic disease requiring daily treatment that would preclude study participation Other
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after study participation
  • HIV negative
  • No known seizure disorder
  • No active infection requiring systemic therapy within the past 2 weeks
  • No known hypersensitivity to topotecan hydrochloride
  • No medical or psychiatric condition that would preclude study participation
  • No other malignancy except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or stage A low-grade prostate cancer PRIOR CONCURRENT THERAPY: Biologic therapy
  • Not specified Chemotherapy
  • See Disease Characteristics
  • More than 4 weeks since prior antineoplastic and/or myelosuppressive chemotherapy
  • No more than 1 prior chemotherapy regimen (except for adjuvant chemotherapy) for SCLC
  • No prior topotecan hydrochloride Endocrine therapy
  • Not specified Radiotherapy
  • Not specified Surgery
  • Not specified Other
  • More than 2 months since prior investigational agent
  • No other concurrent investigational agent

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

  • Josephine Ford Cancer Center at Henry Ford HospitalDetroit, Michigan
  • Case Comprehensive Cancer CenterCleveland, Ohio

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Mar 22, 2016. Always confirm current availability with the study team.

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