Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00043862
First received: August 14, 2002
Last updated: March 1, 2013
Last verified: March 2013
  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 2

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:


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
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: topotecan
    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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 1, 2013
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
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Radiation-Sensitizing Agents
Topotecan
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Topoisomerase I Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on November 25, 2014