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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
Not Enrolling
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

- 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

Type of Study:


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:



United States: Food and Drug Administration

Study ID:




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



GSK Investigational Site Phoenix, Arizona  85013 - 4496
GSK Investigational Site Little Rock, Arkansas  72205
GSK Investigational Site Bakersfield, California  93309
GSK Investigational Site Gainesville, Florida  32610
GSK Investigational Site Indianapolis, Indiana  46260
GSK Investigational Site Lexington, Kentucky  40536-0098
GSK Investigational Site New Orleans, Louisiana  70112
GSK Investigational Site Scarborough, Maine  04074
GSK Investigational Site Springfield, Massachusetts  01107
GSK Investigational Site Duluth, Minnesota  55805
GSK Investigational Site St. Louis, Missouri  63141
GSK Investigational Site St. Louis, Montana  63110
GSK Investigational Site Albuquerque, New Mexico  87109
GSK Investigational Site Raleigh, North Carolina  27609
GSK Investigational Site Akron, Ohio  44304
GSK Investigational Site Fort Worth, Texas  76104
GSK Investigational Site Green Bay, Wisconsin  54301