Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00220649
Status:
COMPLETED
Last Update Posted:
2009-08-17
First Post:
2005-09-16
Brief Title:
Safety Study of Combination Chemotherapy in Patients With Metastatic Solid Tumors or Adenocarcinoma of the Pancreas
Sponsor:
St Lukes-Roosevelt Hospital Center
Organization:
St Lukes-Roosevelt Hospital Center
Study Overview
Official Title:
Phase I Study to Determine the Safety Maximum Tolerated Dose and Efficacy of Biweekly Oxaliplatin Eloxatin in Combination With Gemcitabine Irinotecan and 5-FULeucovorin G-Flie in Patients With Metastatic Solid Tumors or Adenocarcinoma of the Exocrine Pancreas
Status:
COMPLETED
Status Verified Date:
2009-08
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:
The purpose of this trial is to determine the maximum tolerated dose and the dose-limiting toxicity of biweekly oxaliplatin in combination with fixed doses of irinotecan 5-fluorouracilleucovorin and gemcitabine in patients with metastatic solid tumors or adenocarcinoma of the pancreas
Detailed Description:
Pancreatic cancer is a major health problem in the United States and other developed nations Approximately thirty thousand cases of adenocarcinoma of the exocrine pancreas are diagnosed in the United States each year The majority of these tumors are unresectable at the time of diagnosis Unresectable and metastatic pancreatic cancer is often resistant to treatment with response rates of less than 10 and median survival times of less than six months associated with single agent chemotherapy As of July 2003 gemcitabine remains the standard of care palliative chemotherapy for patients with locally advanced or metastatic pancreatic cancer This drug has modest clinical activity In a phase III randomized controlled trial 126 patients with advanced symptomatic pancreatic cancer were randomized to receive either gemcitabine 1000 mgm2 weekly x 7 followed by a week of rest and then weekly x 3 every 4 weeks thereafter or fluorouracil 600 mgm2 once weekly The primary endpoint was a score of clinical benefit response CBR derived from a composite of pain performance status and weight CBR was experienced by 24 of the gemcitabine treated patients compared with 5 of 5-FU treated patients The median survival durations were 565 and 441 months for gemcitabine-treated and 5-FU-treated patients respectively The one year survival was 18 for patients treated with gemcitabine compared to 2 for patients treated with 5-FU The effectiveness of gemcitabine may be improved by altering the standard infusion schedule to a fixed dose rate Gemcitabine requires intracellular phosphorylation to form active di- and triphosphates which is dose rate dependent A phase II trial randomized patients to either receive gemcitabine 2200 mgm2 over a standard 30 minute infusion or gemcitabine 1500 mgm2 at a fixed rate of 10 mgm2min weekly x 3 every 4 weeks The fixed rate infusion of 10 mgm2min was associated with a higher response rate of 166 v 27 longer median survival 61 v 47 months and a higher percentage of patients surviving one year or more 23 v 0 The fixed rate infusion schedule was also associated with significantly higher median gemcitabine triphosphate levels in peripheral circulating mononuclear cells after each infusion
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 |
|---|---|---|---|
| OX-03-049 | None | None | None |