Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00017303
Status:
UNKNOWN
Last Update Posted:
2013-11-06
First Post:
2001-06-06
Brief Title:
Combination Chemotherapy Plus IM-862 in Treating Patients With Resected Stage III Ovarian Cancer or Primary Peritoneal Cancer
Sponsor:
Cytran
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Trial Of IM862 Combined With Paclitaxel And Carboplatin In Newly Diagnosed Advanced Epithelial Ovarian Or Primary Peritoneal Carcinoma Followed By IM862 Consolidation Therapy
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 IM-862 may kill tumor cells by stopping blood flow to the tumor and by stimulating a persons white blood cells to kill tumor cells Combining chemotherapy and IM-862 may kill more tumor cells
PURPOSE Randomized phase II trial to study the effectiveness of combination chemotherapy and IM-862 in treating patients who have resected stage III ovarian cancer or primary peritoneal cancer
PURPOSE Randomized phase II trial to study the effectiveness of combination chemotherapy and IM-862 in treating patients who have resected stage III ovarian cancer or primary peritoneal cancer
Detailed Description:
OBJECTIVES I Determine the complete pathologic response rate at second-look surgery in patients with optimally resected stage III ovarian epithelial or primary peritoneal cancer treated with adjuvant paclitaxel carboplatin and IM-862 II Determine the safety profile of this regimen in this patient population III Determine the incidence of infectious and hematologic complications in patients treated with this regimen IV Determine the progression-free survival of patients with no disease or minimal disease burden after initial therapy when treated with IM-862 consolidation therapy V Correlate angiogenesis markers and immunologic parameters with response in patients treated with this regimen
OUTLINE This is a randomized double-blind multicenter study Patients are stratified according to participating center Patients are randomized to one of three IM-862 doses Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity Treatment with IM-862 begins within 10 days of chemotherapy initiation and continues until clinical evidence of disease progression or until 3 days before second-look surgery Arm I Patients receive a low-dose of IM-862 and 2 placebo doses intranasally daily Arm II Patients receive a medium-dose of IM-862 and 2 placebo doses as in arm I Arm III Patients receive higher-dose IM-862 intranasally three times daily Patients undergo second-look surgery within 4-8 weeks after completion of the last course of chemotherapy Patients with a complete pathologic response or only microscopically detectable residual disease receive consolidation therapy with IM-862 according to their original treatment arm Consolidation therapy begins within 3-14 days after second-look surgery and continues for 24 weeks in the absence of disease progression Patients are followed at 6 and 12 months
PROJECTED ACCRUAL A total of 180 patients 60 per arm will be accrued for this study within 1 year
OUTLINE This is a randomized double-blind multicenter study Patients are stratified according to participating center Patients are randomized to one of three IM-862 doses Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity Treatment with IM-862 begins within 10 days of chemotherapy initiation and continues until clinical evidence of disease progression or until 3 days before second-look surgery Arm I Patients receive a low-dose of IM-862 and 2 placebo doses intranasally daily Arm II Patients receive a medium-dose of IM-862 and 2 placebo doses as in arm I Arm III Patients receive higher-dose IM-862 intranasally three times daily Patients undergo second-look surgery within 4-8 weeks after completion of the last course of chemotherapy Patients with a complete pathologic response or only microscopically detectable residual disease receive consolidation therapy with IM-862 according to their original treatment arm Consolidation therapy begins within 3-14 days after second-look surgery and continues for 24 weeks in the absence of disease progression Patients are followed at 6 and 12 months
PROJECTED ACCRUAL A total of 180 patients 60 per arm will be accrued for this study within 1 year
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 |
|---|---|---|---|
| FHCRC-5156 | None | None | None |
| CYTRAN-IM862-302 | None | None | None |