Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00022217
Status:
UNKNOWN
Last Update Posted:
2013-12-18
First Post:
2001-08-10
Brief Title:
Cisplatin-Epinephrine Injectable Gel Plus Paclitaxel and Carboplatin in Treating Patients With Recurrent Head and Neck Cancer
Sponsor:
Matrix Pharmaceutical
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Activity And Safety Study Of IntraDose CisplatinEpinephrine Injectable Gel When Given In Combination With Systematic Chemotherapy Paclitaxel And Carboplatin In The Treatment Of Patients With Squamous Cell Carcinoma Of The Head And Neck At First Relapse
Status:
UNKNOWN
Status Verified Date:
2002-02
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 Giving more than one drug and giving the drugs in different ways may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of cisplatin-epinephrine injectable gel plus paclitaxel and carboplatin in treating patients who have recurrent head and neck cancer
PURPOSE Phase II trial to study the effectiveness of cisplatin-epinephrine injectable gel plus paclitaxel and carboplatin in treating patients who have recurrent head and neck cancer
Detailed Description:
OBJECTIVES I Determine the antitumor activity of intratumoral cisplatin-epinephrine injectable gel and systemic paclitaxel and carboplatin in patients with recurrent squamous cell carcinoma of the head and neck II Determine the safety of this regimen in this patient population III Determine the time to progression pattern of progression and rate of relapse of patients treated with this regimen VI Determine the time to response and duration of response of patients treated with this regimen V Determine the overall survival of patients treated with this regimen
OUTLINE This is a multicenter study Patients receive cisplatin-epinephrine gel intratumorally on days -15 -8 1 8 15 and 22 for course 1 and days 1 8 15 and 22 for all subsequent courses Patients also receive paclitaxel IV over at least 3 hours followed by carboplatin IV over at least 30 minutes on day 1 Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity Patients who achieve local complete response CR and no metastatic disease progression continue treatment with carboplatin and paclitaxel only Patients who achieve total CR may receive 2 additional courses of carboplatin and paclitaxel Patients are followed at 1-4 weeks and then every 3 months thereafter
PROJECTED ACCRUAL Approximately 40 patients will be accrued for this study
OUTLINE This is a multicenter study Patients receive cisplatin-epinephrine gel intratumorally on days -15 -8 1 8 15 and 22 for course 1 and days 1 8 15 and 22 for all subsequent courses Patients also receive paclitaxel IV over at least 3 hours followed by carboplatin IV over at least 30 minutes on day 1 Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity Patients who achieve local complete response CR and no metastatic disease progression continue treatment with carboplatin and paclitaxel only Patients who achieve total CR may receive 2 additional courses of carboplatin and paclitaxel Patients are followed at 1-4 weeks and then every 3 months thereafter
PROJECTED ACCRUAL Approximately 40 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 |
|---|---|---|---|
| ENH-EH01-102 | None | None | None |
| MP-601-00-2 | None | None | None |