Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00095901
Status:
COMPLETED
Last Update Posted:
2018-03-29
First Post:
2004-11-09
Brief Title:
Capecitabine For Nasopharyngeal Cancer
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
A Phase II Study Of Capecitabine In Previously Treated Recurrent AndOr Metastatic Nasopharyngeal Carcinoma
Status:
COMPLETED
Status Verified Date:
2018-03
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 study plans to examine the effects of Capecitabine administered as an oral chemotherapy drug in participants with nasopharyngeal cancer
Capecitabine is an oral prodrug A prodrug is a drug that is converted within the body into its active form that has medical effects Capecitabine is a prodrug of 5-fluorouracil 5-FU which is a chemotherapy agent frequently used to treat head and neck cancers Capecitabine is absorbed through the gastrointestinal tract and is converted to 5-FU Capecitabine Xeloda9 has been tested in subjects with colorectal and breast cancers and shown to be effective in those cancers Likewise 5-FU has shown benefit when administered as a continuous infusion for those with nasopharyngeal cancers Since Capecitabine is a prodrug of 5-FU it is possible that similar results will be achieved
RATIONALE Drugs used in chemotherapy such as capecitabine work in different ways to stop tumor cells from dividing so they stop growing or die
PURPOSE Phase II trial to study the effectiveness of capecitabine in treating patients who have locally recurrent or metastatic nasopharyngeal cancer
Capecitabine is an oral prodrug A prodrug is a drug that is converted within the body into its active form that has medical effects Capecitabine is a prodrug of 5-fluorouracil 5-FU which is a chemotherapy agent frequently used to treat head and neck cancers Capecitabine is absorbed through the gastrointestinal tract and is converted to 5-FU Capecitabine Xeloda9 has been tested in subjects with colorectal and breast cancers and shown to be effective in those cancers Likewise 5-FU has shown benefit when administered as a continuous infusion for those with nasopharyngeal cancers Since Capecitabine is a prodrug of 5-FU it is possible that similar results will be achieved
RATIONALE Drugs used in chemotherapy such as capecitabine work in different ways to stop tumor cells from dividing so they stop growing or die
PURPOSE Phase II trial to study the effectiveness of capecitabine in treating patients who have locally recurrent or metastatic nasopharyngeal cancer
Detailed Description:
This is a nonrandomized multicenter study
- Patients receive oral capecitabine twice daily on days 1-14 Treatment repeats every 21 days
- Patients receive oral capecitabine twice daily on days 1-14 Treatment repeats every 21 days
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 |
|---|---|---|---|
| P30CA006516 | NIH | None | httpsreporternihgovquickSearchP30CA006516 |