Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005822
Status:
COMPLETED
Last Update Posted:
2010-06-11
First Post:
2000-06-02
Brief Title:
SU5416 and Doxorubicin in Treating Patients With Stage IIIB or Stage IV Inflammatory Breast Cancer
Sponsor:
Case Comprehensive Cancer Center
Organization:
Case Comprehensive Cancer Center
Study Overview
Official Title:
A Phase I Pharmacokinetic Pharmacodynamic and Clinical Study of the Combination of the Angiogenesis Inhibitor SU5416 and Doxorubicin in Inflammatory Breast Cancer
Status:
COMPLETED
Status Verified Date:
2010-06
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 SU5416 may stop the growth of breast cancer by stopping blood flow to the tumor Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining SU5416 with chemotherapy may kill more cancer cells
PURPOSE Phase I trial to study the effectiveness of combining SU5416 and doxorubicin in treating patients who have stage IIIB or stage IV inflammatory breast cancer
PURPOSE Phase I trial to study the effectiveness of combining SU5416 and doxorubicin in treating patients who have stage IIIB or stage IV inflammatory breast cancer
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of SU5416 and doxorubicin in patients with stage IIIB or IV inflammatory breast cancer
Determine the overall response response rate and progression-free survival rate of patients treated with this regimen
Determine the antiangiogenic effects of this regimen in these patients
Assess the relationship of plasma levels of these drugs with safety and efficacy in these patients
OUTLINE This is a dose-escalation study
Patients receive doxorubicin IV continuously over 72 hours on days 1-3 of course 1 For all subsequent courses patients receive doxorubicin as in course 1 and SU5416 IV over 1 hour twice weekly on days 1 and 4 beginning on week 2 of course 2 Treatment repeats every 21 days for 5 courses in the absence of disease progression or unacceptable toxicity After chemotherapy all patients undergo a modified radical mastectomy and radiotherapy to the chest wall and regional lymph nodes Patients with estrogen or progesterone receptor positive disease receive oral tamoxifen for 5 years after radiotherapy
Cohorts of 3-6 patients receive escalating doses of SU5416 and doxorubicin until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity Once the MTD is determined an additional 3 patients may be treated at that dose level
Patients are followed every 3 months until disease progression
PROJECTED ACCRUAL A total of 15-30 patients will be accrued for this study within 6-9 months
Determine the maximum tolerated dose of SU5416 and doxorubicin in patients with stage IIIB or IV inflammatory breast cancer
Determine the overall response response rate and progression-free survival rate of patients treated with this regimen
Determine the antiangiogenic effects of this regimen in these patients
Assess the relationship of plasma levels of these drugs with safety and efficacy in these patients
OUTLINE This is a dose-escalation study
Patients receive doxorubicin IV continuously over 72 hours on days 1-3 of course 1 For all subsequent courses patients receive doxorubicin as in course 1 and SU5416 IV over 1 hour twice weekly on days 1 and 4 beginning on week 2 of course 2 Treatment repeats every 21 days for 5 courses in the absence of disease progression or unacceptable toxicity After chemotherapy all patients undergo a modified radical mastectomy and radiotherapy to the chest wall and regional lymph nodes Patients with estrogen or progesterone receptor positive disease receive oral tamoxifen for 5 years after radiotherapy
Cohorts of 3-6 patients receive escalating doses of SU5416 and doxorubicin until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity Once the MTD is determined an additional 3 patients may be treated at that dose level
Patients are followed every 3 months until disease progression
PROJECTED ACCRUAL A total of 15-30 patients will be accrued for this study within 6-9 months
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-T99-0099 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA043703 |
| U01CA062502 | NIH | None | None |
| P30CA043703 | NIH | None | None |
| CWRU-5199 | None | None | None |