Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003426
Status:
COMPLETED
Last Update Posted:
2013-06-21
First Post:
1999-11-01
Brief Title:
Gemcitabine Plus Radiation Therapy in Treating Patients With Pancreatic Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
A Phase I Trial of Combined Modality Gemcitabine Plus Radiation Therapy for Patients With Locally Advanced Unresectable Pancreatic Adenocarcinoma
Status:
COMPLETED
Status Verified Date:
2013-06
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 Radiation therapy uses high-energy x-rays to damage tumor cells Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining radiation therapy with chemotherapy may kill more tumor cells
PURPOSE Phase I trial to study the effectiveness of gemcitabine plus radiation therapy in treating patients with pancreatic cancer that can not be surgically removed
PURPOSE Phase I trial to study the effectiveness of gemcitabine plus radiation therapy in treating patients with pancreatic cancer that can not be surgically removed
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose of gemcitabine in combination with radiation therapy to patients with locally advanced andor unresectable adenocarcinoma of the pancreas II Determine the dose limiting toxic effects of this combination therapy in these patients III Evaluate the ability of these patients to tolerate induction and then maintenance therapy with gemcitabine preceding and following combination therapy IV Evaluate the efficacy response rate pattern of failure and survival of this combination therapy in these patients
OUTLINE This is a dose escalation study of gemcitabine Part I Patients receive gemcitabine as a continuous infusion over 30 minutes once weekly for 3 weeks followed by 1 week of rest Part II Gemcitabine IV is administered as a 30 minute infusion twice a week Monday and Thursday for 5-6 weeks Patients receive radiation therapy 5 days a week for 5-6 weeks In the absence of dose-limiting toxicity DLT in the first 6 patients treated subsequent cohorts of 6 patients each receive escalating doses of gemcitabine on the same schedule If DLT occurs in 2 of 6 patients at a given dose level then dose escalation ceases and the next lower dose is declared the maximum tolerated dose Part III In the absence of toxicity and disease progression patients continue gemcitabine for 3 additional courses Maintenance gemcitabine starts 4 weeks after the completion of radiation therapy and is administered once weekly for 3 weeks followed by 1 week of rest Patients are followed until death
PROJECTED ACCRUAL This study will accrue 15-30 patients in approximately 24 months
OUTLINE This is a dose escalation study of gemcitabine Part I Patients receive gemcitabine as a continuous infusion over 30 minutes once weekly for 3 weeks followed by 1 week of rest Part II Gemcitabine IV is administered as a 30 minute infusion twice a week Monday and Thursday for 5-6 weeks Patients receive radiation therapy 5 days a week for 5-6 weeks In the absence of dose-limiting toxicity DLT in the first 6 patients treated subsequent cohorts of 6 patients each receive escalating doses of gemcitabine on the same schedule If DLT occurs in 2 of 6 patients at a given dose level then dose escalation ceases and the next lower dose is declared the maximum tolerated dose Part III In the absence of toxicity and disease progression patients continue gemcitabine for 3 additional courses Maintenance gemcitabine starts 4 weeks after the completion of radiation therapy and is administered once weekly for 3 weeks followed by 1 week of rest Patients are followed until death
PROJECTED ACCRUAL This study will accrue 15-30 patients in approximately 24 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 |
|---|---|---|---|
| NCI-H98-0020 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000066451 | REGISTRY | None | None |