Weekly Topotecan With Docetaxel in Recurrent Small Cell Lung Cancer - Full Text View

Sponsors and Collaborators:	Aultman Hospital GlaxoSmithKline
Information provided by:	Aultman Hospital
ClinicalTrials.gov Identifier:	NCT00315211

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 II

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Docetaxel Topotecan hydrochloride Topotecan

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase 2 Study of Weekly Topotecan With Docetaxel for Recurrent Small Cell Lung Cancer

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

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

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

Keywords provided by Aultman Hospital:

Small Cell Lung Cancer Recurrent

Study placed in the following topic categories:

Thoracic Neoplasms
Carcinoma, Neuroendocrine
Thoracic Diseases
Recurrence
Carcinoma
Neuroendocrine Tumors
Docetaxel
Carcinoma, Small Cell
Neuroectodermal Tumors
Respiratory Tract Diseases

Lung Neoplasms
Neoplasms, Germ Cell and Embryonal
Lung Diseases
Neuroepithelioma
Topotecan
Adenocarcinoma
Mediastinal Neoplasms
Mediastinal Diseases
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents
Therapeutic Uses
Neoplasms, Nerve Tissue
Enzyme Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009