Description Module

Description Module

The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.

Description Module path is as follows:

Study -> Protocol Section -> Description Module

Description Module


Ignite Creation Date: 2025-12-25 @ 2:47 AM
Ignite Modification Date: 2025-12-25 @ 2:47 AM
NCT ID: NCT00030433
Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have extensive-stage small cell lung cancer.
Detailed Description: OBJECTIVES: * Determine the survival of patients with extensive stage small cell lung cancer treated with gemcitabine and irinotecan. * Determine the response rates (confirmed and unconfirmed, complete and partial) of patients treated with this regimen. * Determine the overall toxic effects of this regimen in these patients. OUTLINE: This is a multicenter study. Patients receive gemcitabine IV over 30 minutes followed by irinotecan IV over 90 minutes on days 1 and 8. Treatment repeats every 21 days for a total of 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 months for 3 years. PROJECTED ACCRUAL: A total of 75 patients will be accrued for this study within 12 months.
Study: NCT00030433
Study Brief:
Protocol Section: NCT00030433