TerminatedPhase 2NCT00087048

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

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.

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

StatusTerminated
PhasePhase 2
U.S. locations2
SponsorCase Comprehensive Cancer Center
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.

03
Public criteria

Who may be able to participate

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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