Skip to content
Triangle logo TriangleGet started
← Study library

NCT00003917 · CITED IN SOURCE DOCUMENTS

Topotecan in Treating Patients With Relapsed Small Cell Lung Cancer

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE3
Status at capture
COMPLETED
Registry last update
2014-01-09

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if topotecan is more effective given by infusion or by mouth. PURPOSE: Randomized phase III trial to compare the effectiveness of topotecan given by infusion with that of topotecan given by mouth in treating patients who have small cell lung cancer that has relapsed following previous therapy.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed limited or extensive stage small cell lung cancer (SCLC) Disease recurring at least 90 days following completion of first line chemotherapy Partial or complete response to first line therapy Must have at least one bidimensionally measurable non CNS lesion May be within a prior radiation port if at least 6 weeks since prior radiotherapy and progressing Brain and/or leptomeningeal metastases allowed if asymptomatic and not requiring corticosteroids PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 2 months Hematopoietic: WBC at least 3,500/mm3 Neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9.0 g/dL (after transfusion, if needed) Hepatic: Bilirubin no greater than 2.0 mg/dL SGOT and SGPT no greater than 2 times upper limit of normal (ULN) (no greater than 5 times ULN if liver metastases present) Alkaline phosphatase no greater than 2 times ULN (no greater than 5 times ULN if liver metastases present) Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Other: No active uncontrolled infection No other malignancies within the past 5 years except curatively treated basal or squamous cell skin cancer, carcinoma in situ of the cervix, or stage I low grade prostate cancer No other severe medical conditions that would preclude study or cause exposure to extreme risk or decreased life expectancy No uncontrolled emesis No active peptic ulcer, diabetes mellitus, chronic gastritis, significant ascites, or other gastrointestinal (GI) conditions (e.g., removal of a portion of the stomach or recent GI obstruction) that would alter absorption or GI motility No history of allergic reactions to compounds chemically related to topotecan Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception for 3 months prior to, during, and at least 4 weeks after the study PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 months since prior immunotherapy No concurrent immunotherapy for SCLC Chemotherapy: See Disease Characteristics No prior topotecan Only one prior chemotherapy regimen allowed No other concurrent chemotherapy for SCLC Endocrine therapy: See Disease Characteristics Radiotherapy: See Disease Characteristics At least 24 hours since prior radiotherapy No concurrent radiotherapy for SCLC Surgery: At least 4 weeks since prior surgery Other: At least 30 days or five half lives since other prior investigational drugs No prior drugs (e.g., cisapride) that would alter absorption or GI motility No other concurrent investigational therapy for SCLC
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
interventions
  1. name
    topotecan hydrochloride
    type
    DRUG
Study design
allocation
RANDOMIZED
intervention Model
SINGLE_GROUP
primary Purpose
TREATMENT
Enrollment
count
4
type
ACTUAL
Registered outcome plans (not posted results)
Full study description
brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if topotecan is more effective given by infusion or by mouth. PURPOSE: Randomized phase III trial to compare the effectiveness of topotecan given by infusion with that of topotecan given by mouth in treating patients who have small cell lung cancer that has relapsed following previous therapy.
detailed Description
OBJECTIVES: I. Compare the response rate, response duration, time to response, time to progression, and survival of patients with relapsed limited or extensive stage small cell lung cancer treated with oral vs intravenous topotecan. II. Compare the qualitative and quantitative toxicities of these treatment regimens in this patient population. III. Compare the quality of life in these patients. OUTLINE: This is randomized, multicenter study. Patients are stratified according to gender, liver metastases (yes vs no), and duration of response to prior chemotherapy (6 months or less vs greater than 6 months). Patients are randomized to one of two treatment arms. Arm I: Patients receive topotecan IV over 30 minutes on days 1-5. Arm II: Patients receive topotecan orally on days 1-5. Treatment repeats every 3 weeks in the absence of unacceptable toxicity. Patients experiencing complete or partial response continue until progression or for at least 2 courses past maximal response. Patients with stable disease should receive at least 4 courses. Quality of life is assessed Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 300 patients (150 per treatment arm) will be accrued for this study.
Source references
references
  1. citation
    Eckardt JR, von Pawel J, Pujol JL, Papai Z, Quoix E, Ardizzoni A, Poulin R, Preston AJ, Dane G, Ross G. Phase III study of oral compared with intravenous topotecan as second-line therapy in small-cell lung cancer. J Clin Oncol. 2007 May 20;25(15):2086-92. doi: 10.1200/JCO.2006.08.3998.
    pmid
    17513814
    type
    RESULT
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-7ad944f6deaf1f5cd6122126
      edge id
      nct-edge-2261848771ecd45ebf6d
      requested nct id
      NCT00003917
      primary nct id
      NCT00003917
      source kind
      nci_explicit_reference_or_link
      source record id
      Source null
      source file sha256
      def8807fa9dced3053a5e17815e0b3a72969a547af852b3a8a8c6960753960cd
      payload sha256
      25bb2222682638f1ce1444cc14119ff8017fc90f80d45c77a85e43cdb66792ea
      payload
      clinical indication matching status
      not_inferred
      end exclusive
      true
      id
      nct-edge-2261848771ecd45ebf6d
      link basis
      explicit_NCT_identifier_in_acquired_source
      nct id
      NCT00003917
      occurrences
      1. context exact
        13.9 weeks for BSC alone (<em>P</em> = .01).[<a href="#cit/section_7.10">10</a>]</li><li>A randomized phase III trial (CWRU-SKF-1598 [<a href="/clinicaltrials/NCT00003917">NCT00003917</a>]) of 304 patients assessed the use of oral topotecan (2.3 mg/m<span class="sup">2</span>/day for 5 days every 21 days) or intravenous topoteca
        end
        178848
        exact text
        NCT00003917
        start
        178837
      2. context exact
        or BSC alone (<em>P</em> = .01).[<a href="#cit/section_7.10">10</a>]</li><li>A randomized phase III trial (CWRU-SKF-1598 [<a href="/clinicaltrials/NCT00003917">NCT00003917</a>]) of 304 patients assessed the use of oral topotecan (2.3 mg/m<span class="sup">2</span>/day for 5 days every 21 days) or intravenous topotecan (1.5 mg/m<s
        end
        178861
        exact text
        NCT00003917
        start
        178850
      offset unit
      unicode_code_points
      source file
      /tmp/cancer-full-research/nci/raw/2cbbafe249fd41eec1.html
      source file sha256
      def8807fa9dced3053a5e17815e0b3a72969a547af852b3a8a8c6960753960cd
      source json pointer
      Source null
      source kind
      nci_explicit_reference_or_link
      source record id
      Source null
      source retrieved at
      2026-09-09T23:21:59.810322+00:00
      source string basis
      UTF-8_text_with_universal_newline_translation
      source string sha256
      b376c91ad09eb8f2c14d2bbdf7eadfa5634343c1e1f1e7885a272dfdb4eb487c
      source title
      Small Cell Lung Cancer Treatment (PDQ®)–Health Professional Version
      source update dates
      1. context
        Updated: May 14, 2025
        datetime
        2025-05-14T12:00:00Z
        display
        May 14, 2025

    Preserved source evidence · Not medical advice