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

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ClinicalTrials.gov Identifier: NCT00043862
Recruitment Status : Completed
First Posted : August 15, 2002
Last Update Posted : May 31, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Lung Cancer, Small Cell Small Cell Lung Cancer Drug: topotecan Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : August 2002
Primary Completion Date : November 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Response rate

Secondary Outcome Measures :
  1. Time to Progression, response duration, survival, quantitative and qualitative assessment of tolerability

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

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): NCT00043862


  Show 31 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
More Information

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00043862     History of Changes
Other Study ID Numbers: 104864/535
First Posted: August 15, 2002    Key Record Dates
Last Update Posted: May 31, 2017
Last Verified: March 2013

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
Topotecan
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents