Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003044
Status:
UNKNOWN
Last Update Posted:
2013-12-19
First Post:
1999-11-01
Brief Title:
Chemotherapy in Treating Patients With Liver Cancer
Sponsor:
Matrix Pharmaceutical
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Two-Stage Phase II Safety and Efficacy Study of IntraDose CisplatinEpinephrine Injectable Gel MPI 5010 Administered to Patients With Unresectable Primary Hepatocellular Carcinoma
Status:
UNKNOWN
Status Verified Date:
2000-04
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 drugs in different ways may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of cisplatin and epinephrine administered directly into the tumor in treating patients who have primary liver cancer that cannot be removed during surgery
PURPOSE Phase II trial to study the effectiveness of cisplatin and epinephrine administered directly into the tumor in treating patients who have primary liver cancer that cannot be removed during surgery
Detailed Description:
OBJECTIVES I Evaluate the safety and efficacy of cisplatin-epinephrine injectable gel Intradose MPI-5010 in patients with unresectable primary hepatocellular carcinoma
OUTLINE This is an open label two stage multicenter study Patients receive intratumoral treatment with ciplatin-epinephrine MPI-5010 once weekly for up to four treatments within a six week period followed by an evaluation two weeks after last treatment Immediately after the first course an optional second course of treatment may be undertaken at the discretion of the investigator Patients with a complete response partial response andor an increase in necrosis of at least 30 of total treated tumor volume will be followed monthly for up to 6 months At the completion of 6 months follow up or following documentation of disease progression or development of new tumors patients are monitored for survival in an extended follow up period All nonresponders at the last 2 week posttreatment evaluation are entered in the extended follow up and monitored monthly for survival
PROJECTED ACCRUAL Up to 55 patients will be accrued for this study
OUTLINE This is an open label two stage multicenter study Patients receive intratumoral treatment with ciplatin-epinephrine MPI-5010 once weekly for up to four treatments within a six week period followed by an evaluation two weeks after last treatment Immediately after the first course an optional second course of treatment may be undertaken at the discretion of the investigator Patients with a complete response partial response andor an increase in necrosis of at least 30 of total treated tumor volume will be followed monthly for up to 6 months At the completion of 6 months follow up or following documentation of disease progression or development of new tumors patients are monitored for survival in an extended follow up period All nonresponders at the last 2 week posttreatment evaluation are entered in the extended follow up and monitored monthly for survival
PROJECTED ACCRUAL Up to 55 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 |
|---|---|---|---|
| NCI-V97-1290 | None | None | None |
| MP-417-96-2 | None | None | None |