Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003264
Status:
COMPLETED
Last Update Posted:
2013-04-17
First Post:
1999-11-01
Brief Title:
Cisplatin Plus Gemcitabine in Treating Patients With Advanced Squamous Cell Head and Neck Cancer
Sponsor:
Fox Chase Cancer Center
Organization:
Fox Chase Cancer Center
Study Overview
Official Title:
Phase II Evaluation of Weekly Cisplatin and Gemcitabine in the Treatment of Advanced Recurrent or Metastatic Carcinoma of the Head and Neck
Status:
COMPLETED
Status Verified Date:
2013-04
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 Combining more than one drug may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of cisplatin plus gemcitabine in treating patients with advanced squamous cell head and neck cancer that cannot be treated by surgery or radiation therapy
PURPOSE Phase II trial to study the effectiveness of cisplatin plus gemcitabine in treating patients with advanced squamous cell head and neck cancer that cannot be treated by surgery or radiation therapy
Detailed Description:
OBJECTIVES I Evaluate the response rate and toxicity of weekly cisplatin and gemcitabine in patients with recurrent or metastatic squamous cell carcinoma of the head and neck who have received either no prior chemotherapy or no more than one prior chemotherapy regimen for advanced disease
OUTLINE Patients are stratified according to prior chemotherapy status chemotherapy naive no prior chemotherapy or prior neoadjuvant or adjuvant chemotherapy at least 6 months prior to recurrence or prior biologic agents only vs chemotherapy exposed one prior chemotherapy regimen directed at recurrent or newly diagnosed metastatic disease andor prior neoadjuvant or adjuvant chemotherapy less than 6 months prior to recurrence Patients receive gemcitabine as a 30 minute infusion weekly for 3 weeks followed by one week of rest Cisplatin is administered as a 30-60 minute infusion immediately preceding gemcitabine Treatment repeats every 28 days for 2-6 courses depending on response Patients with previously untreated metastatic disease may have treatment interrupted to receive radiation therapy to locoregional disease sites Patients may continue treatment beyond 6 courses at the discretion of the physician Patients are followed every 3 months
PROJECTED ACCRUAL This study will accrue approximately 36 patients
OUTLINE Patients are stratified according to prior chemotherapy status chemotherapy naive no prior chemotherapy or prior neoadjuvant or adjuvant chemotherapy at least 6 months prior to recurrence or prior biologic agents only vs chemotherapy exposed one prior chemotherapy regimen directed at recurrent or newly diagnosed metastatic disease andor prior neoadjuvant or adjuvant chemotherapy less than 6 months prior to recurrence Patients receive gemcitabine as a 30 minute infusion weekly for 3 weeks followed by one week of rest Cisplatin is administered as a 30-60 minute infusion immediately preceding gemcitabine Treatment repeats every 28 days for 2-6 courses depending on response Patients with previously untreated metastatic disease may have treatment interrupted to receive radiation therapy to locoregional disease sites Patients may continue treatment beyond 6 courses at the discretion of the physician Patients are followed every 3 months
PROJECTED ACCRUAL This study will accrue approximately 36 patients
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-G98-1403 | OTHER | National Cancer Institute | httpsreporternihgovquickSearchP30CA006927 |
| P30CA006927 | NIH | None | None |
| FCCC-97021 | OTHER | None | None |