Weekly Topotecan With Docetaxel in Recurrent Small Cell Lung Cancer

This study has been terminated.
(Slow Accrual)
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
Aultman Hospital
ClinicalTrials.gov Identifier:
NCT00315211
First received: April 17, 2006
Last updated: October 31, 2007
Last verified: October 2007
  Purpose

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

  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Ohio
Aultman Hospital
Canton, Ohio, United States, 44710
Sponsors and Collaborators
Aultman Hospital
GlaxoSmithKline
Investigators
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
Small Cell Lung Carcinoma
Mediastinal Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Mediastinal Diseases
Thoracic Diseases
Docetaxel
Topotecan
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 18, 2014