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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 : August 20, 2018
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Aultman Health Foundation

April 17, 2006
April 18, 2006
August 20, 2018
November 2004
June 2007   (Final data collection date for primary outcome measure)
To determine the overall response rate of patients treated with at least two cycles of topotecan and docetaxel [ Time Frame: 3 years ]
To determine the overall response rate of patients treated with at least two cycles of topotecan and docetaxel
Not Provided
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.

The main objective of this study was to determine the overall response rate of patients treated with at least 2 cycles of topotecan and docetaxel. The secondary objectives were to determine the feasibility and toxicities of this combination. The final secondary objective is overall survival for patients that received 2 or more cycles.

Methods: Eligible pts with recurrent small cell lung cancer had to be at least 3 months from initial treatment. Pts received Docetaxel 30 mg/m2 IV followed by Topotecan 3 mg/m2 IV Days 1 and 8 of a 21 day cycle. Disease assessment was done every 2 cycles. Toxicity was measured each cycle.

Interventional
Phase 2
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
    Other Name: Hycamtin
  • Drug: Intravenous Docetaxel
    Docetaxel 30 mg/m2 IV over 60 minutes on Days 1 & 8 of a 21 day cycle
    Other Name: Taxotere
Arm A
Weekly intravenous topotecan with intravenous docetaxel
Interventions:
  • Drug: Intravenous Topotecan
  • Drug: Intravenous Docetaxel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
7
40
November 8, 2007
June 2007   (Final data collection date for primary outcome measure)

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)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00315211
Hycamtin study #102143
Lung 01 ( Other Identifier: Aultman Health Foundation )
Not Provided
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Aultman Health Foundation
Aultman Health Foundation
GlaxoSmithKline
Principal Investigator: Raza Khan, MD Aultman Hospital
Aultman Health Foundation
August 2018

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