Ignite Creation Date:
2024-05-05 @ 9:42 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004097
Status:
UNKNOWN
Last Update Posted:
2013-09-20
First Post:
1999-12-10
Brief Title:
Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Advanced andor Recurrent Head and Neck Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Study of Concomitant Chemoradiotherapy With Gemcitabine Paclitaxel and 5-FU for Patients With Advanced andor Recurrent Cancer of the Head and Neck
Status:
UNKNOWN
Status Verified Date:
2001-10
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 tumor cells from dividing so they stop growing or die Radiation therapy uses high-energy x-rays to damage tumor cells Combining chemotherapy with radiation therapy may kill more tumor cells
PURPOSE Phase I trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating patients who have advanced andor recurrent head and neck cancer
PURPOSE Phase I trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating patients who have advanced andor recurrent head and neck cancer
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose MTD and dose-limiting toxicity DLT of gemcitabine when administered with paclitaxel and fluorouracil with concurrent hyperfractionated radiotherapy in patients with advanced andor recurrent head and neck cancer II Determine the MTD and DLT of gemcitabine as a single agent with radiotherapy in these patients III Determine the efficacy of concurrent chemoradiotherapy in terms of time to progression pattern of failure and overall survival in patients with measurable disease IV Determine gemcitabine and fluorouracil pharmacokinetics in these patients
OUTLINE This is a dose escalation study of gemcitabine conducted in two phases Phase A Patients receive fluorouracil IV continuously on days 1-5 paclitaxel IV over 1 hour on day 2 and radiotherapy administered twice daily on days 1-5 This regimen is repeated every 2 weeks for 2 courses then gemcitabine IV over 30 minutes is added on day 2 after paclitaxel This regimen is administered every 2 weeks for 3 courses Patients with responsive disease may continue chemotherapy without radiotherapy for 2 courses beyond maximum response Cohorts of 3-6 patients receive escalating doses of gemcitabine until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which 3 of 6 patients experience dose-limiting toxicity Phase B After the MTD of gemcitabine is determined in phase A further dose escalation of gemcitabine may be performed with concurrent radiotherapy without fluorouracil or paclitaxel The MTD is determined as in phase A Patients are followed monthly for 1 year and then every 3 months thereafter
PROJECTED ACCRUAL A total of 30-40 patients will be accrued for this study within approximately 2 years
OUTLINE This is a dose escalation study of gemcitabine conducted in two phases Phase A Patients receive fluorouracil IV continuously on days 1-5 paclitaxel IV over 1 hour on day 2 and radiotherapy administered twice daily on days 1-5 This regimen is repeated every 2 weeks for 2 courses then gemcitabine IV over 30 minutes is added on day 2 after paclitaxel This regimen is administered every 2 weeks for 3 courses Patients with responsive disease may continue chemotherapy without radiotherapy for 2 courses beyond maximum response Cohorts of 3-6 patients receive escalating doses of gemcitabine until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which 3 of 6 patients experience dose-limiting toxicity Phase B After the MTD of gemcitabine is determined in phase A further dose escalation of gemcitabine may be performed with concurrent radiotherapy without fluorouracil or paclitaxel The MTD is determined as in phase A Patients are followed monthly for 1 year and then every 3 months thereafter
PROJECTED ACCRUAL A total of 30-40 patients will be accrued for this study within approximately 2 years
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-G99-1590 | None | None | None |
| NU-C97N2 | None | None | None |