The Study Of An Oral Drug Called A Radiation Sensitizer In Patients With Newly Diagnosed Small Cell Lung Cancer (SCLC)

This study has been completed.

First Received on August 14, 2002. Last Updated on March 17, 2011 History of Changes

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00043862

Purpose

This study will gather information on the effectiveness and safety of a treatment program for small cell lung cancer (SCLC) that uses an FDA approved chemotherapy combination, radiation therapy, and an oral investigational drug that may enhance the effects of radiation therapy. Study patients will receive two additional courses of the standard chemotherapy combination after completing radiation therapy.

Condition	Intervention	Phase
Lung Cancer, Small Cell Small Cell Lung Cancer	Drug: topotecan	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:	A Phase II Trial of Twice Daily Oral Topotecan as a Radiation Sensitizer With Twice Daily Radiotherapy for Newly Diagnosed Small Cell Lung Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Topotecan hydrochloride Topotecan

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Response rate

Secondary Outcome Measures:

Time to Progression, response duration, survival, quantitative and qualitative assessment of tolerability

Enrollment:	60
Study Start Date:	August 2002

Intervention Details:

Other Name: topotecan

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients must have newly diagnosed, limited stage SCLC (small cell lung cancer), with no prior radiotherapy. Patients are allowed to have had a resection or biopsy.
Women of reproductive potential must have a negative serum pregnancy test at the study screening visit.
Patients must give written informed consent to participate in the study.
Patients must be able to take oral medication.
Patients should be completely recovered from recent surgery.
Laboratory criteria: Patients must have adequate bone marrow reserve and adequate kidney and liver function.
Patients must be evaluated by the radiation oncologist prior to study entry.

Exclusion Criteria:

Extensive Stage SCLC.
Women who are pregnant or lactating.
Use of an investigational drug within 30 days prior to the first dose of study medication.
Any medically/clinically significant active infection.
Symptoms of the SCLC spreading to the brain.
Patients with limited stage SCLC who have undergone complete resection with no measurable disease prior to starting chemotherapy.
Severe medical problems, unrelated to SCLC, that would limit the patient's full ability to follow all study rules and procedures, or that would expose the patient to extreme risk.
Other ongoing, immunotherapy or radiotherapy being administered at the time as study participation.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00043862

Show 31 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT00043862 History of Changes
Other Study ID Numbers:	104864/535
Study First Received:	August 14, 2002
Last Updated:	March 17, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

Hycamtin
oral
Radiation Sensitization
Small Cell Lung Cancer

newly diagnosed
limited stage
topotecan

Additional relevant MeSH terms:

Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms

Radiation-Sensitizing Agents
Topotecan
Physiological Effects of Drugs
Pharmacologic Actions
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 12, 2012