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.