Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003182
Status:
UNKNOWN
Last Update Posted:
2013-12-04
First Post:
1999-11-01
Brief Title:
Cisplatin and Gemcitabine in Treating Patients With Advanced Squamous Cell Cancer of the Head and Neck
Sponsor:
Hope Cancer Institute Inc
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase III Study Using Cisplatin and Gemcitabine Gemzar for Advanced Head and Neck Cancer Squamous Cell Carcinoma
Status:
UNKNOWN
Status Verified Date:
2000-07
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 Combining more than one drug may kill more tumor cells
PURPOSE Phase III trial to study the effectiveness of cisplatin and gemcitabine in treating patients with advanced squamous cell cancer of the head and neck that cannot be surgically removed
PURPOSE Phase III trial to study the effectiveness of cisplatin and gemcitabine in treating patients with advanced squamous cell cancer of the head and neck that cannot be surgically removed
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose and dose limiting toxicity of gemcitabine used in combination with cisplatin in the treatment of squamous cell carcinoma of the head and neck II Determine the toxicity profile of this combination treatment in these patients III Assess the response rate of treatment in these patients
OUTLINE This is a dose escalation study of gemcitabine Patients receive gemcitabine as an IV bolus on day 1 every 2 weeks Cisplatin is administered on day 1 every 2 weeks In the absence of dose limiting toxicity DLT in the first 3 patients treated subsequent cohorts of 3 patients each receive escalating doses of gemcitabine on the same schedule If 1 of 3 patients in each cohort experiences DLT an additional 3 patients are enrolled at that same dose level If 2 of 3 patients experiences DLT in the cohort then dose escalation ceases and the next lower dose is declared the maximum tolerated dose Patients are assessed for response every 2 weeks Patients may continue treatment for up to 9 months or until disease progression
PROJECTED ACCRUAL At least 3 patients will be accrued for phase I and 20-40 patients will be accrued for phase II of this study
OUTLINE This is a dose escalation study of gemcitabine Patients receive gemcitabine as an IV bolus on day 1 every 2 weeks Cisplatin is administered on day 1 every 2 weeks In the absence of dose limiting toxicity DLT in the first 3 patients treated subsequent cohorts of 3 patients each receive escalating doses of gemcitabine on the same schedule If 1 of 3 patients in each cohort experiences DLT an additional 3 patients are enrolled at that same dose level If 2 of 3 patients experiences DLT in the cohort then dose escalation ceases and the next lower dose is declared the maximum tolerated dose Patients are assessed for response every 2 weeks Patients may continue treatment for up to 9 months or until disease progression
PROJECTED ACCRUAL At least 3 patients will be accrued for phase I and 20-40 patients will be accrued for phase II of 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-V98-1374 | None | None | None |
| HCRN-003 | None | None | None |