Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00012220
Status:
COMPLETED
Last Update Posted:
2016-07-14
First Post:
2001-03-03
Brief Title:
Gemcitabine Alone or in Combination With Other Chemotherapy Drugs in Treating Patients With Metastatic Cancer of the Pancreas
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
A Randomized Phase II Study Of GemcitabineCisplatin GemcitabineDocetaxel GemcitabineIrinotecan Or Fixed Dose Rate Infusion Gemcitabine In Patients With Metastic Pancreatic Cancer
Status:
COMPLETED
Status Verified Date:
2016-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U10CA031946 | NIH | None | None |
| CALGB-89904 | None | None | None |
| CDR0000068495 | REGISTRY | NCI Physician Data Query | httpsreporternihgovquickSearchU10CA031946 |