Weekly Topotecan With Docetaxel in Recurrent Small Cell Lung Cancer

This study has been terminated.

( Slow Accrual )

First Received on April 17, 2006. Last Updated on October 31, 2007 History of Changes

Sponsor:	Aultman Hospital
Collaborator:	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

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:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Docetaxel Topotecan hydrochloride Topotecan

U.S. FDA Resources

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

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:

Neoplasms
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
Topotecan
Docetaxel
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012