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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

Brief Summary:

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 or disease Intervention/treatment Phase
Mediastinal Neoplasms Drug: Intravenous Topotecan Drug: Intravenous Docetaxel Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Study of Weekly Topotecan With Docetaxel for Recurrent Small Cell Lung Cancer
Study Start Date : November 2004
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00315211     History of Changes
Other Study ID Numbers: Hycamtin study #102143
Aultman Lung 01
First Posted: April 18, 2006    Key Record Dates
Last Update Posted: November 2, 2007
Last Verified: October 2007

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
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors