Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005996
Status:
UNKNOWN
Last Update Posted:
2013-12-19
First Post:
2000-07-05
Brief Title:
SU5416 Combined With Gemcitabine and Cisplatin in Treating Patients With Advanced Solid Tumors
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Study of SU5416 in Combination With GemcitabineCisplatin in Patients With Advanced Solid Tumors
Status:
UNKNOWN
Status Verified Date:
2000-09
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 SU5416 may stop the growth of solid tumors by stopping blood flow to the tumor Combining more than once chemotherapy drug with SU5416 may kill more tumor cells
PURPOSE Phase I trial to study the effectiveness of SU5416 combined with gemcitabine and cisplatin in treating patients who have advanced solid tumors
PURPOSE Phase I trial to study the effectiveness of SU5416 combined with gemcitabine and cisplatin in treating patients who have advanced solid tumors
Detailed Description:
OBJECTIVES I Assess the toxicities and pharmacokinetics of SU5416 when combined with gemcitabine and cisplatin in patients with advanced solid tumors II Determine the antitumor activity of this combination treatment regimen in this patient population
OUTLINE This is an open label dose escalation study of SU5416 Patients receive gemcitabine IV over 30 minutes followed by cisplatin IV over 1 hour on day 1 SU5416 IV over 70 minutes on day 4 gemcitabine IV over 30 minutes followed by SU5416 IV over 70 minutes on day 8 and SU5416 on days 11 15 and 18 Treatment repeats every 3 weeks for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity Following 6 courses of therapy patients with stable and responsive disease may receive SU5416 alone on days 1 4 8 11 15 and 18 every 3 weeks for a maximum of 1 year 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 at least one third of the patients experience dose limiting toxicity Patients are followed at 1 month and then every 3 months
PROJECTED ACCRUAL A total of 16-30 patients will be accrued for this study
OUTLINE This is an open label dose escalation study of SU5416 Patients receive gemcitabine IV over 30 minutes followed by cisplatin IV over 1 hour on day 1 SU5416 IV over 70 minutes on day 4 gemcitabine IV over 30 minutes followed by SU5416 IV over 70 minutes on day 8 and SU5416 on days 11 15 and 18 Treatment repeats every 3 weeks for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity Following 6 courses of therapy patients with stable and responsive disease may receive SU5416 alone on days 1 4 8 11 15 and 18 every 3 weeks for a maximum of 1 year 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 at least one third of the patients experience dose limiting toxicity Patients are followed at 1 month and then every 3 months
PROJECTED ACCRUAL A total of 16-30 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-G00-1805 | None | None | None |
| UCLA-0002046 | None | None | None |
| SUGEN-ND019901SE5416102 | None | None | None |