Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004242
Status:
COMPLETED
Last Update Posted:
2013-02-11
First Post:
2000-01-28
Brief Title:
Combination Chemotherapy in Treating Patients With Metastatic or Unresectable Solid Tumors
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase I Study of Oxaliplatin in Combination With 5-Fluorouracil and Gemcitabine in Patients With Solid Tumors
Status:
COMPLETED
Status Verified Date:
2002-07
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:
Phase I trial to study the effectiveness of combination chemotherapy in treating patients who have metastatic or unresectable solid tumors Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining more than one drug may kill more tumor cells
Detailed Description:
OBJECTIVES
I Determine the maximum tolerated dose recommended phase II dose and associated toxic effects of the triple combination of continuous infusion fluorouracil weekly gemcitabine and oxaliplatin in patients with metastatic or unresectable solid tumors
II Define sequence dependent toxic effects if any and establish pharmacokinetic and pharmacodynamic relationships in context of this triple combination chemotherapy in this patient population
OUTLINE This is a dose-escalation study of oxaliplatin and gemcitabine
For course 1 and then course 3 and beyond patients receive oxaliplatin IV over 2 hours on day 1 followed by gemcitabine IV over 30 minutes on days 1 and 8 and then fluorouracil IV continuously on days 1-14 For course 2 patients receive treatment in the same manner as in course 1 except gemcitabine is given initially followed by oxaliplatin and then fluorouracil Treatment continues every 21 days in the absence of unacceptable toxicity or disease progression
Cohorts of 1-6 patients receive escalating doses of oxaliplatin and gemcitabine until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity The recommended phase II dose RPTD is defined as the dose preceding MTD
Once RPTD is defined the cohort is expanded to an additional 13 patients These patients receive a fixed dose of oxaliplatin gemcitabine and fluorouracil as determined by the phase I dose escalation portion of this study
Patients are followed for disease progression
I Determine the maximum tolerated dose recommended phase II dose and associated toxic effects of the triple combination of continuous infusion fluorouracil weekly gemcitabine and oxaliplatin in patients with metastatic or unresectable solid tumors
II Define sequence dependent toxic effects if any and establish pharmacokinetic and pharmacodynamic relationships in context of this triple combination chemotherapy in this patient population
OUTLINE This is a dose-escalation study of oxaliplatin and gemcitabine
For course 1 and then course 3 and beyond patients receive oxaliplatin IV over 2 hours on day 1 followed by gemcitabine IV over 30 minutes on days 1 and 8 and then fluorouracil IV continuously on days 1-14 For course 2 patients receive treatment in the same manner as in course 1 except gemcitabine is given initially followed by oxaliplatin and then fluorouracil Treatment continues every 21 days in the absence of unacceptable toxicity or disease progression
Cohorts of 1-6 patients receive escalating doses of oxaliplatin and gemcitabine until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity The recommended phase II dose RPTD is defined as the dose preceding MTD
Once RPTD is defined the cohort is expanded to an additional 13 patients These patients receive a fixed dose of oxaliplatin gemcitabine and fluorouracil as determined by the phase I dose escalation portion of this study
Patients are followed for disease progression
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 |
|---|---|---|---|
| AECM-1199904138 | None | None | None |
| NCI-T99-0023 | None | None | None |
| NYU-9944 | None | None | None |