Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006000
Status:
COMPLETED
Last Update Posted:
2013-01-31
First Post:
2000-07-05
Brief Title:
SU5416 Irinotecan and Cisplatin in Treating Patients With Advanced Solid Tumors
Sponsor:
Ohio State University Comprehensive Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase I Study of SU5416 in Combination With CPT-11 and Cisplatin in Patients With Solid Tumors
Status:
COMPLETED
Status Verified Date:
2002-01
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 SU5416 may stop the growth of solid tumors by stopping blood flow to the tumor Combining SU5416 with chemotherapy may kill more cancer cells
PURPOSE Phase I trial to study the effectiveness of SU5416 plus irinotecan and cisplatin in treating patients who have advanced solid tumors
PURPOSE Phase I trial to study the effectiveness of SU5416 plus irinotecan and cisplatin in treating patients who have advanced solid tumors
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose of SU5416 in combination with irinotecan and cisplatin in patients with advanced solid tumors II Determine the quantitative and qualitative toxicity of this treatment regimen in terms of organ specificity time course predictability and reversibility in this patient population III Determine the therapeutic response of this treatment regimen in these patients IV Evaluate the clinical pharmacokinetics and the relationship of kinetics to toxicity and response in this patient population treated with this regimen
OUTLINE This is a dose escalation study of SU5416 Patients receive cisplatin IV over 90 minutes immediately followed by irinotecan IV over 90 minutes and SU5416 IV over 2 hours on day 1 Patients receive SU5416 alone on day 4 Patients receive combination chemotherapy weekly for 4 weeks and SU5416 twice weekly for 6 weeks Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of SU5416 until the maximum tolerated dose MTD is reached The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity
PROJECTED ACCRUAL A total of 3-24 patients will be accrued for this study
OUTLINE This is a dose escalation study of SU5416 Patients receive cisplatin IV over 90 minutes immediately followed by irinotecan IV over 90 minutes and SU5416 IV over 2 hours on day 1 Patients receive SU5416 alone on day 4 Patients receive combination chemotherapy weekly for 4 weeks and SU5416 twice weekly for 6 weeks Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of SU5416 until the maximum tolerated dose MTD is reached The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity
PROJECTED ACCRUAL A total of 3-24 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-47 | None | None | None |
| OSU-00H0033 | None | None | None |