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A Phase II Trial of Twice Daily Oral Topotecan as a Radiation Sensitizer With Twice Daily Radiotherapy for Newly Diagnosed Small Cell Lung Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Lung Cancer, Small Cell, Small Cell Lung Cancer

Thank you

Trial Information

A Phase II Trial of Twice Daily Oral Topotecan as a Radiation Sensitizer With Twice Daily Radiotherapy for Newly Diagnosed Small Cell Lung Cancer


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate

Principal Investigator

GSK Clinical Trials, MD

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

United States: Food and Drug Administration

Study ID:

104864/535

NCT ID:

NCT00043862

Start Date:

August 2002

Completion Date:

Related Keywords:

  • Lung Cancer, Small Cell
  • Small Cell Lung Cancer
  • Hycamtin
  • oral
  • Radiation Sensitization
  • Small Cell Lung Cancer
  • newly diagnosed
  • limited stage
  • topotecan
  • Lung Neoplasms
  • Small Cell Lung Carcinoma

Name

Location

GSK Investigational SitePhoenix, Arizona  85013 - 4496
GSK Investigational SiteLittle Rock, Arkansas  72205
GSK Investigational SiteBakersfield, California  93309
GSK Investigational SiteGainesville, Florida  32610
GSK Investigational SiteIndianapolis, Indiana  46260
GSK Investigational SiteLexington, Kentucky  40536-0098
GSK Investigational SiteNew Orleans, Louisiana  70112
GSK Investigational SiteScarborough, Maine  04074
GSK Investigational SiteSpringfield, Massachusetts  01107
GSK Investigational SiteDuluth, Minnesota  55805
GSK Investigational SiteSt. Louis, Missouri  63141
GSK Investigational SiteSt. Louis, Montana  63110
GSK Investigational SiteAlbuquerque, New Mexico  87109
GSK Investigational SiteRaleigh, North Carolina  27609
GSK Investigational SiteAkron, Ohio  44304
GSK Investigational SiteFort Worth, Texas  76104
GSK Investigational SiteGreen Bay, Wisconsin  54301