Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002659
Status:
UNKNOWN
Last Update Posted:
2013-12-19
First Post:
1999-11-01
Brief Title:
Cisplatin Plus Epinephrine in Treating Patients With Recurrent or Refractory Head and Neck Cancer
Sponsor:
Matrix Pharmaceutical
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A RANDOMIZED DOUBLE-BLIND PLACEBO CONTROLLED STUDY TO EVALUATE THE EFFECT OF CISPLATINEPINEPHRINE INJECTABLE GEL PRODUCT MPI 5010 WHEN ADMINISTERED INTRATUMORALLY FOR ACHIEVEMENT OF TREATMENT GOALS IN RECURRENT OR REFRACTORY SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK
Status:
UNKNOWN
Status Verified Date:
2007-05
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 It is not yet known if treatment with cisplatin plus epinephrine is effective for head and neck cancer
PURPOSE Randomized double-blinded phase III trial to determine the effectiveness of cisplatin plus epinephrine in injectable gel form in treating patients who have recurrent or refractory head and neck cancer
PURPOSE Randomized double-blinded phase III trial to determine the effectiveness of cisplatin plus epinephrine in injectable gel form in treating patients who have recurrent or refractory head and neck cancer
Detailed Description:
OBJECTIVES I Compare the effect of intratumoral injection of a cisplatinepinephrine gel CDDP-e TI to placebo gel for local control of recurrent or refractory squamous cell carcinoma of the head and neck II Assess achievement of a preselected by the investigator treatment goal for the most troublesome tumor in patients with recurrent or refractory squamous cell carcinoma of the head and neck following up to 6 weekly intratumoral treatments with CDDP-e TI vs placebo gel III Compare the effect of CDDP-e TI to placebo gel on total local tumor volume per patient IV Evaluate the time to response and time to progression for the most troublesome tumor after local treatment with CDDP-e TI vs placebo gel V Assess the improvement in or stabilization of quality of life in these patients as measured by the FACT-HN questionnaire VI Compare the histopathology of injected lesions that respond to local treatment
OUTLINE Randomized double-blind study Randomization weighted 21 in favor of Arm I Arm I Intratumoral Chemotherapy Cisplatin NSC-119875 and Epinephrine in a bovine collagen gel MP 5010 CDDP-e TI Arm II Control NS in a bovine collagen gel PLCB
PROJECTED ACCRUAL Up to 120 evaluable patients will be studied to provide 80 evaluable patients on Arm I and 40 evaluable patients on Arm II
OUTLINE Randomized double-blind study Randomization weighted 21 in favor of Arm I Arm I Intratumoral Chemotherapy Cisplatin NSC-119875 and Epinephrine in a bovine collagen gel MP 5010 CDDP-e TI Arm II Control NS in a bovine collagen gel PLCB
PROJECTED ACCRUAL Up to 120 evaluable patients will be studied to provide 80 evaluable patients on Arm I and 40 evaluable patients on Arm II
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-V95-0676 | None | None | None |
| MP-414-94-2 | None | None | None |