Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003332
Status:
COMPLETED
Last Update Posted:
2011-03-28
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy Followed by Chemotherapy and Radiation Therapy andor Surgery in Treating Patients Who Have Pancreatic Cancer
Sponsor:
NYU Langone Health
Organization:
NYU Langone Health
Study Overview
Official Title:
Phase III Study of Induction Chemotherapy With Gemcitabine and Cisplatin Followed by Combined Chemo-radiation andor Surgical Resection for Locally Advanced Pancreatic Cancer
Status:
COMPLETED
Status Verified Date:
2011-03
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 Combining more than one drug with radiation therapy andor surgery may kill more tumor cells
PURPOSE Phase III trial to study the effectiveness of combination chemotherapy consisting of gemcitabine and cisplatin followed by chemotherapy and radiation therapy andor surgery in treating patients who have pancreatic cancer
PURPOSE Phase III trial to study the effectiveness of combination chemotherapy consisting of gemcitabine and cisplatin followed by chemotherapy and radiation therapy andor surgery in treating patients who have pancreatic cancer
Detailed Description:
OBJECTIVES
Determine the response rate of patients with locally advanced pancreatic cancer after induction therapy with gemcitabine and cisplatin
Determine the maximum tolerated dose of gemcitabine and cisplatin chemotherapy combined with radiation therapy in these patients
Determine the overall response rates in these patients after this combined modality regimen following induction chemotherapy
Determine the resectability rate for locally advanced pancreatic lesions treated with this regimen
Determine the time to failure for the entire treatment program
OUTLINE This is a dose-escalation study
Patients receive gemcitabine IV over 30 minutes on days 1 8 and 15 Following gemcitabine patients receive cisplatin IV over 1 hour on days 1 8 and 15 Course is repeated every 4 weeks After 2 courses of induction chemotherapy disease is restaged
Patients may then receive radiotherapy in addition to chemotherapy Radiotherapy is given daily for 5 weeks and 3 days During radiotherapy cohorts of 3 patients are treated with escalating doses of gemcitabine and cisplatin administered as described above in induction chemotherapy The maximum tolerated dose MTD is defined as the lowest dose at which no more than 2 of 6 or 2 of 3 patients experience dose limiting toxicity When the MTD has been determined additional patients accrued into the study receive the dose level immediately below the MTD
If after 2 courses of induction chemotherapy with gemcitabine and cisplatin the tumor is radiographically considered resectable by operating surgeon the patient undergoes surgical exploration or laparoscopy for staging and verification of resectability If the tumor is found to be resectable without evidence of distant disease the patient undergoes complete surgical resection and radiation plus adjuvant gemcitabine and cisplatin
Patients are followed every 3 months until death
PROJECTED ACCRUAL Approximately 15-36 patients will be accrued for the Phase I portion of this study and there will be 14-25 patients accrued into the Phase II portion of this study
Determine the response rate of patients with locally advanced pancreatic cancer after induction therapy with gemcitabine and cisplatin
Determine the maximum tolerated dose of gemcitabine and cisplatin chemotherapy combined with radiation therapy in these patients
Determine the overall response rates in these patients after this combined modality regimen following induction chemotherapy
Determine the resectability rate for locally advanced pancreatic lesions treated with this regimen
Determine the time to failure for the entire treatment program
OUTLINE This is a dose-escalation study
Patients receive gemcitabine IV over 30 minutes on days 1 8 and 15 Following gemcitabine patients receive cisplatin IV over 1 hour on days 1 8 and 15 Course is repeated every 4 weeks After 2 courses of induction chemotherapy disease is restaged
Patients may then receive radiotherapy in addition to chemotherapy Radiotherapy is given daily for 5 weeks and 3 days During radiotherapy cohorts of 3 patients are treated with escalating doses of gemcitabine and cisplatin administered as described above in induction chemotherapy The maximum tolerated dose MTD is defined as the lowest dose at which no more than 2 of 6 or 2 of 3 patients experience dose limiting toxicity When the MTD has been determined additional patients accrued into the study receive the dose level immediately below the MTD
If after 2 courses of induction chemotherapy with gemcitabine and cisplatin the tumor is radiographically considered resectable by operating surgeon the patient undergoes surgical exploration or laparoscopy for staging and verification of resectability If the tumor is found to be resectable without evidence of distant disease the patient undergoes complete surgical resection and radiation plus adjuvant gemcitabine and cisplatin
Patients are followed every 3 months until death
PROJECTED ACCRUAL Approximately 15-36 patients will be accrued for the Phase I portion of this study and there will be 14-25 patients accrued into the Phase II portion of this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-G98-1423 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA016087 |
| P30CA016087 | NIH | None | None |
| NYU-9703 | None | None | None |