Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004164
Status:
UNKNOWN
Last Update Posted:
2009-02-09
First Post:
1999-12-10
Brief Title:
Combination Chemotherapy in Treating Patients With Stage IIB Stage III or Stage IV Cancer of the Nasopharynx
Sponsor:
Dana-Farber Cancer Institute
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Trial of Docetaxel Cisplatin 5-FU and Leucovorin for Carcinoma of the Nasopharnyx
Status:
UNKNOWN
Status Verified Date:
2000-09
Last Known Status:
ACTIVE_NOT_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 use different ways to stop cancer cells from dividing so they stop growing or die Combining more than one drug may kill more cancer cells
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have stage IIB stage III or stage IV cancer of the nasopharynx
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have stage IIB stage III or stage IV cancer of the nasopharynx
Detailed Description:
OBJECTIVES I Determine the complete and overall response rate to docetaxel cisplatin fluorouracil and leucovorin calcium in patients with potentially curable nasopharyngeal cancer II Assess the tolerability of this regimen in these patients
OUTLINE Patients receive docetaxel IV over 1 hour followed 1 hour later by cisplatin IV over 4 hours and fluorouracil IV and leucovorin calcium IV over 96 hours Filgrastim G-CSF is administered subcutaneously beginning on day 5 and continuing until blood counts recover or day 10 Treatment repeats every 3 weeks for up to 3 courses Within 2 weeks after the completion of chemotherapy patients undergo definitive radiotherapy for about 7 weeks After radiotherapy patients who did not achieve complete remission after chemotherapy may undergo surgery Patients are followed monthly for 1 year then every 3 months thereafter
PROJECTED ACCRUAL A total of 45 patients will be accrued for this study
OUTLINE Patients receive docetaxel IV over 1 hour followed 1 hour later by cisplatin IV over 4 hours and fluorouracil IV and leucovorin calcium IV over 96 hours Filgrastim G-CSF is administered subcutaneously beginning on day 5 and continuing until blood counts recover or day 10 Treatment repeats every 3 weeks for up to 3 courses Within 2 weeks after the completion of chemotherapy patients undergo definitive radiotherapy for about 7 weeks After radiotherapy patients who did not achieve complete remission after chemotherapy may undergo surgery Patients are followed monthly for 1 year then every 3 months thereafter
PROJECTED ACCRUAL A total of 45 patients will be accrued for this study
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 |
|---|---|---|---|
| NCI-G99-1631 | None | None | None |
| DFCI-99132 | None | None | None |
| RP-DFCI-99132 | None | None | None |