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Weekly Topotecan With Docetaxel in Recurrent Small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT00315211
Recruitment Status : Terminated (Slow Accrual)
First Posted : April 18, 2006
Last Update Posted : November 2, 2007
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
Aultman Hospital

April 17, 2006
April 18, 2006
November 2, 2007
November 2004
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To determine the overall response rate of patients treated with at least two cycles of this regimen [ Time Frame: 3 years ]
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Complete list of historical versions of study NCT00315211 on ClinicalTrials.gov Archive Site
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Weekly Topotecan With Docetaxel in Recurrent Small Cell Lung Cancer
Phase 2 Study of Weekly Topotecan With Docetaxel for Recurrent Small Cell Lung Cancer

The purposes of this study are:

  • To determine the overall response rate of patients treated with at least 2 cycles of this regimen.
  • To determine the feasibility and toxicity of the combination of topotecan and docetaxel.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Mediastinal Neoplasms
  • Drug: Intravenous Topotecan
    Topotecan 3 mg/m2 IV over 30 minutes on Days 1 and 8 every 21 days
  • Drug: Intravenous Docetaxel
    Docetaxel 30 mg/m2 IV over 60 minutes on Days 1 & 8 of a 21 day cycle
Arm A
Interventions:
  • Drug: Intravenous Topotecan
  • Drug: Intravenous Docetaxel
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
40
Same as current
June 2007
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Inclusion Criteria:

  • Recurred greater than 90 days after initial treatment
  • At least 1 measurable lesion
  • Only 1 prior chemotherapy
  • Must be over 18 years of age
  • ECOG performance status of 0 - 2
  • Adequate hematologic, renal, and hepatic function

Exclusion Criteria:

  • No prior use of topotecan, docetaxel, or irinotecan
  • No symptomatic brain metastases
  • History of cardiac arrhythmias, congestive heart failure, stroke, or embolic events
  • No prior investigational agents within 1 month prior
  • Lung cancer of mixed histology
  • Known uncontrolled seizure disorders
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00315211
Hycamtin study #102143
Aultman Lung 01
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Aultman Hospital
GlaxoSmithKline
Principal Investigator: Raza Khan, MD Aultman Hospital
Aultman Hospital
October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP