Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00043121
Status:
COMPLETED
Last Update Posted:
2013-12-11
First Post:
2002-08-05
Brief Title:
Combination Chemotherapy in Treating Patients With Advanced Cancer That is Metastatic or Cannot Be Removed By Surgery
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Study of Oxaliplatin 5-Fluorouracil and Leucovorin in Combination With Oral Capecitabine in Patients With Advanced Malignancy
Status:
COMPLETED
Status Verified Date:
2013-12
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:
This phase I trial studies the side effects and best dose of capecitabine when given together with oxaliplatin leucovorin calcium and fluorouracil in treating patients with advanced cancer that is metastatic or cannot be removed by surgery 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:
PRIMARY OBJECTIVES
I To establish the MTD and toxicity profile of oral capecitabine in combination with q 2 weekly intravenous oxaliplatin in patients with advanced malignancies
SECONDARY OBJECTIVES
I To characterize the pharmacokinetic parameters of capecitabine at the recommended phase II dose for combinations of capecitabine oxaliplatin 5-fluorouracil and leucovorin as well as for the combination of capecitabine and oxaliplatin
II To observe for and record any antitumor activity
OUTLINE This is a dose-escalation study of capecitabine
Patients receive oxaliplatin IV over 2 hours leucovorin calcium IV and fluorouracil IV on days 1 and 15 Patients also receive oral capecitabine every 8 hours on days 1-2 and 15-16 Leucovorin calcium and fluorouracil administration is held at dose level 4 and above Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
I To establish the MTD and toxicity profile of oral capecitabine in combination with q 2 weekly intravenous oxaliplatin in patients with advanced malignancies
SECONDARY OBJECTIVES
I To characterize the pharmacokinetic parameters of capecitabine at the recommended phase II dose for combinations of capecitabine oxaliplatin 5-fluorouracil and leucovorin as well as for the combination of capecitabine and oxaliplatin
II To observe for and record any antitumor activity
OUTLINE This is a dose-escalation study of capecitabine
Patients receive oxaliplatin IV over 2 hours leucovorin calcium IV and fluorouracil IV on days 1 and 15 Patients also receive oral capecitabine every 8 hours on days 1-2 and 15-16 Leucovorin calcium and fluorouracil administration is held at dose level 4 and above Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
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 |
|---|---|---|---|
| U01CA062491 | NIH | CTEP | httpsreporternihgovquickSearchU01CA062491 |
| NCI-2013-00004 | REGISTRY | None | None |
| WCCC-CO-02901 | None | None | None |
| NCI-5904 | None | None | None |
| CO 02901 | OTHER | None | None |
| 5904 | OTHER | None | None |