Ignite Creation Date:
2024-05-05 @ 10:05 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004901
Status:
COMPLETED
Last Update Posted:
2013-06-26
First Post:
2000-03-07
Brief Title:
Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Advanced Mouth Cancer
Sponsor:
Robert H Lurie Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Study of Concomitant Chemoradiotherapy With 776C85 5-FU and Hydroxyurea for Patients With Poor Prognosis Oral Cancer
Status:
COMPLETED
Status Verified Date:
2000-08
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:
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 more than one chemotherapy drug with radiation therapy may kill more tumor cells
PURPOSE Phase III trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating patients who have advanced mouth cancer
PURPOSE Phase III trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating patients who have advanced mouth cancer
Detailed Description:
OBJECTIVES I Assess the feasibility of the administration of ethynyluracil concurrently with fluorouracil and radiotherapy in patients with advanced oral cancer II Determine the maximum tolerated dose MTD and dose-limiting toxicities of this regimen in this patient population
OUTLINE This is a dose escalation study of fluorouracil and hydroxyurea Patients receive oral ethynyluracil every 12 hours on days 1-7 and oral fluorouracil every 12 hours on days 2-6 Radiotherapy to the head and neck is administered twice daily on days 2-6 Treatment continues for 5-7 courses in the absence of unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of fluorouracil until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 3 of 6 patients experience dose limiting toxicities Once the MTD of fluorouracil is determined hydroxyurea is added to the treatment regimen Patients receive fluorouracil and ethynyluracil as per the treatment schedule outlined above Patients also receive oral hydroxyurea every 12 hours for 11 doses on days 1-6 Radiotherapy is administered as above Cohorts of 3-6 patients receive escalating doses of hydroxyurea until the MTD is determined Once the MTD of fluorouracil and hydroxyurea are determined an additional 10 patients receive Phase II doses of ethynyluracil fluorouracil and hydroxyurea as per the treatment schedule outlined above Treatment continues in the absence of unacceptable toxicity Patients are followed at 4-6 weeks then every 6 months until death
PROJECTED ACCRUAL Approximately 40 patients will be accrued for this study over 2 years
OUTLINE This is a dose escalation study of fluorouracil and hydroxyurea Patients receive oral ethynyluracil every 12 hours on days 1-7 and oral fluorouracil every 12 hours on days 2-6 Radiotherapy to the head and neck is administered twice daily on days 2-6 Treatment continues for 5-7 courses in the absence of unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of fluorouracil until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 3 of 6 patients experience dose limiting toxicities Once the MTD of fluorouracil is determined hydroxyurea is added to the treatment regimen Patients receive fluorouracil and ethynyluracil as per the treatment schedule outlined above Patients also receive oral hydroxyurea every 12 hours for 11 doses on days 1-6 Radiotherapy is administered as above Cohorts of 3-6 patients receive escalating doses of hydroxyurea until the MTD is determined Once the MTD of fluorouracil and hydroxyurea are determined an additional 10 patients receive Phase II doses of ethynyluracil fluorouracil and hydroxyurea as per the treatment schedule outlined above Treatment continues in the absence of unacceptable toxicity Patients are followed at 4-6 weeks then every 6 months until death
PROJECTED ACCRUAL Approximately 40 patients will be accrued for this study over 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-G00-1680 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000067580 | REGISTRY | None | None |