Ignite Creation Date:
2024-05-05 @ 4:51 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00323583
Status:
UNKNOWN
Last Update Posted:
2007-05-08
First Post:
2006-05-05
Brief Title:
Weekly Dosing of an Integrative Chemotherapy Combination to Treat Advanced Pancreatic Cancer
Sponsor:
Seattle Cancer Treatment and Wellness Center
Organization:
Seattle Cancer Treatment and Wellness Center
Study Overview
Official Title:
Phase II Study of Paclitaxel Oxaliplatin Leucovorin and 5-Fluorouracil POLF in Gemcitabine-Refractory Advanced Pancreatic Cancer
Status:
UNKNOWN
Status Verified Date:
2007-05
Last Known Status:
RECRUITING
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 such as paclitaxel oxaliplatin leucovorin and 5-fluoruracil work in different ways separately and in combination to stop tumor cells from dividing so they stop growing or die The use of metronomic dosing of chemotherapy minimizes side effects and increases efficacy by anti-angiogenic effects The pilot study demonstrated promising responses in all patients It is not yet known how effective this drug and dosing combination is in treating advanced pancreatic cancer
PURPOSE This non-randomized phase II trial is studying giving weekly doses of paclitaxel oxaliplatin leucovorin and 5-fluorouracil together as second or third-line therapy in treating patient with locally advanced unresectable or metastatic adenocarcinoma of the pancreas following demonstrated progression after first-line gemcitabine
PURPOSE This non-randomized phase II trial is studying giving weekly doses of paclitaxel oxaliplatin leucovorin and 5-fluorouracil together as second or third-line therapy in treating patient with locally advanced unresectable or metastatic adenocarcinoma of the pancreas following demonstrated progression after first-line gemcitabine
Detailed Description:
OBJECTIVES
The primary objective is to determine the effectiveness the chemotherapy combination in improving the experience of those with advanced pancreatic cancer in
Pain control and other aspects of quality of life
Reduction of the tumor size or stabilization of tumor growth
Progression free survival
Overall survival
The secondary objective is to determine the safety of this chemotherapy combination by monitoring and the managing the potential side effects
DOSE REGIMEN OUTLINE Paclitaxel 60mgm2 IV weekly Oxaliplatin 50mgm2 IV weekly Leucovorin 20 mgm2 IV weekly minimum of 40 mg 5FU 425mgm2 IV weekly Weekly for 12 weeks Calcium and magnesium 1gram each IV prior to and after Oxaliplatin therapy Glutathione 1500mgm2 prior to Oxaliplatin
DURATION OF STUDY PERIOD Patient will continue study treatment until death disease progression unacceptable toxicity patient refusal or treatment delay greater than 3 weeks 12 weeks initially can than continue at discretion of investigator
EXPECTED NUMBER OF PATIENTS A total of 80 patients 40 second line of treatment and 40 third line or greater of treatment will be enrolled for this study beginning in May 2006
QUALITY OF LIFE Quality of life will be assessed at baseline each month of treatment and at the end of study therapy
The primary objective is to determine the effectiveness the chemotherapy combination in improving the experience of those with advanced pancreatic cancer in
Pain control and other aspects of quality of life
Reduction of the tumor size or stabilization of tumor growth
Progression free survival
Overall survival
The secondary objective is to determine the safety of this chemotherapy combination by monitoring and the managing the potential side effects
DOSE REGIMEN OUTLINE Paclitaxel 60mgm2 IV weekly Oxaliplatin 50mgm2 IV weekly Leucovorin 20 mgm2 IV weekly minimum of 40 mg 5FU 425mgm2 IV weekly Weekly for 12 weeks Calcium and magnesium 1gram each IV prior to and after Oxaliplatin therapy Glutathione 1500mgm2 prior to Oxaliplatin
DURATION OF STUDY PERIOD Patient will continue study treatment until death disease progression unacceptable toxicity patient refusal or treatment delay greater than 3 weeks 12 weeks initially can than continue at discretion of investigator
EXPECTED NUMBER OF PATIENTS A total of 80 patients 40 second line of treatment and 40 third line or greater of treatment will be enrolled for this study beginning in May 2006
QUALITY OF LIFE Quality of life will be assessed at baseline each month of treatment and at the end of study therapy
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