Weekly Topotecan With Docetaxel in Recurrent Small Cell Lung Cancer

This study has been terminated.
(Slow Accrual)
Information provided by:
Aultman Hospital
ClinicalTrials.gov Identifier:
First received: April 17, 2006
Last updated: October 31, 2007
Last verified: October 2007

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.

Condition Intervention Phase
Mediastinal Neoplasms
Drug: Intravenous Topotecan
Drug: Intravenous Docetaxel
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 2 Study of Weekly Topotecan With Docetaxel for Recurrent Small Cell Lung Cancer

Resource links provided by NLM:

Further study details as provided by Aultman Hospital:

Primary Outcome Measures:
  • To determine the overall response rate of patients treated with at least two cycles of this regimen [ Time Frame: 3 years ]

Estimated Enrollment: 40
Study Start Date: November 2004
Study Completion Date: June 2007
Arms Assigned Interventions
Arm A 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


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00315211

United States, Ohio
Aultman Hospital
Canton, Ohio, United States, 44710
Sponsors and Collaborators
Aultman Hospital
Principal Investigator: Raza Khan, MD Aultman Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00315211     History of Changes
Other Study ID Numbers: Hycamtin study #102143, Aultman Lung 01
Study First Received: April 17, 2006
Last Updated: October 31, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by Aultman Hospital:
Small Cell Lung Cancer Recurrent

Additional relevant MeSH terms:
Lung Neoplasms
Mediastinal Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Mediastinal Diseases
Thoracic Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014