Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00089024
Status:
COMPLETED
Last Update Posted:
2023-09-29
First Post:
2004-08-04
Brief Title:
Combination Chemotherapy and Radiation Therapy in Treating Patients With Locally Advanced Pancreatic Cancer
Sponsor:
University of Nebraska
Organization:
University of Nebraska
Study Overview
Official Title:
A Phase II Study Of Neo-Adjuvant Chemotherapy And Radiation In Patients With Locally Advanced Pancreatic Cancer
Status:
COMPLETED
Status Verified Date:
2023-09
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 work in different ways to stop tumor cells from dividing so they stop growing or die Radiation therapy uses high-energy x-rays to damage tumor cells Giving combination chemotherapy with radiation therapy before surgery may shrink the tumor so that it can be removed
PURPOSE This phase II trial is studying how well giving combination chemotherapy together with radiation therapy works in treating patients who may undergo surgery for locally advanced pancreatic cancer
PURPOSE This phase II trial is studying how well giving combination chemotherapy together with radiation therapy works in treating patients who may undergo surgery for locally advanced pancreatic cancer
Detailed Description:
OBJECTIVES
Determine the antitumor and clinical benefit response to neoadjuvant chemoradiotherapy comprising gemcitabine fluorouracil leucovorin calcium and oxaliplatin in patients with potentially resectable locally advanced adenocarcinoma of the pancreas
Determine the toxic effects of this regimen in these patients
Determine the achieved steady-state plasma levels of gemcitabine and fluorouracil in these patients and correlate these plasma levels with clinical toxicity associated with this regimen
Determine the potential importance of polymorphic variations in genomic DNA of pertinent genes whose protein products are targets of the antineoplastic drugs used in this study on response to and toxicity of this regimen in these patients
Determine the gene expression profiles of primary and metastatic pancreatic tumors before and after treatment with this regimen
OUTLINE
Neoadjuvant chemotherapy Patients receive gemcitabine IV over 30 minutes and fluorouracil IV continuously over 24 hours on days 2 and 9 and leucovorin calcium orally on days 1 and 8 and IV on days 2 and 9 Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity
Neoadjuvant chemoradiotherapy Beginning on day 42 patients undergo chemoradiotherapy comprising oxaliplatin IV over 2 hours on days 42 49 56 63 70 and 77 and fluorouracil IV continuously on days 42-78 with external beam radiotherapy
Surgery Patients undergo surgical resection 42-56 days after completion of chemoradiotherapy
Adjuvant chemotherapy After post-operative recovery patients receive 2 additional courses of gemcitabine fluorouracil and leucovorin calcium If surgical resection is not possible patients with stable or responsive disease resume gemcitabine fluorouracil and leucovorin calcium indefinitely in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 50 patients will be accrued for this study
Determine the antitumor and clinical benefit response to neoadjuvant chemoradiotherapy comprising gemcitabine fluorouracil leucovorin calcium and oxaliplatin in patients with potentially resectable locally advanced adenocarcinoma of the pancreas
Determine the toxic effects of this regimen in these patients
Determine the achieved steady-state plasma levels of gemcitabine and fluorouracil in these patients and correlate these plasma levels with clinical toxicity associated with this regimen
Determine the potential importance of polymorphic variations in genomic DNA of pertinent genes whose protein products are targets of the antineoplastic drugs used in this study on response to and toxicity of this regimen in these patients
Determine the gene expression profiles of primary and metastatic pancreatic tumors before and after treatment with this regimen
OUTLINE
Neoadjuvant chemotherapy Patients receive gemcitabine IV over 30 minutes and fluorouracil IV continuously over 24 hours on days 2 and 9 and leucovorin calcium orally on days 1 and 8 and IV on days 2 and 9 Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity
Neoadjuvant chemoradiotherapy Beginning on day 42 patients undergo chemoradiotherapy comprising oxaliplatin IV over 2 hours on days 42 49 56 63 70 and 77 and fluorouracil IV continuously on days 42-78 with external beam radiotherapy
Surgery Patients undergo surgical resection 42-56 days after completion of chemoradiotherapy
Adjuvant chemotherapy After post-operative recovery patients receive 2 additional courses of gemcitabine fluorouracil and leucovorin calcium If surgical resection is not possible patients with stable or responsive disease resume gemcitabine fluorouracil and leucovorin calcium indefinitely in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 50 patients will be accrued for this study
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 |
|---|---|---|---|
| P30CA036727 | NIH | None | httpsreporternihgovquickSearchP30CA036727 |