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 @ 4:15 AM
Ignite Modification Date:
2025-12-25 @ 4:15 AM
NCT ID:
NCT00012220
Brief Summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if gemcitabine is more effective when given alone or in combination with another chemotherapy drug in treating cancer of the pancreas.
PURPOSE: Randomized phase II trial to compare the effectiveness of gemcitabine given alone or in combination with other chemotherapy drugs in treating patients who have metastatic cancer of the pancreas.
Detailed Description:
OBJECTIVES:
* Compare the overall survival rate of patients with metastatic pancreatic cancer treated with gemcitabine alone vs with cisplatin vs with docetaxel vs with irinotecan.
* Compare the time to disease progression in patients treated with these regimens.
* Compare the CA 19-9 biomarker response in patients treated with these regimens.
* Correlate the CA 19-9 biomarker response with survival in patients treated with these regimens.
* Compare the toxicity of these regimens in these patients.
* Compare the response in patients with measurable disease treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of four treatment arms.
* Arm I: Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15 followed by cisplatin IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for at least 2 courses in the absence of disease progression or unacceptable toxicity.
* Arm II: Patients receive gemcitabine IV over 150 minutes on days 1, 8, and 15. Treatment repeats every 28 days for at least 2 courses in the absence of disease progression or unacceptable toxicity.
* Arm III: Patients receive gemcitabine IV over 30 minutes followed by docetaxel IV over 60 minutes on days 1 and 8. Treatment repeats every 21 days for at least 3 courses in the absence of disease progression or unacceptable toxicity.
* Arm IV: 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 at least 3 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 1 year and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 240 patients (60 per arm) will be accrued for this study within 30 months.
Study:
NCT00012220
Study Brief:
Protocol Section:
NCT00012220