Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00031681
Status:
COMPLETED
Last Update Posted:
2013-09-30
First Post:
2002-03-08
Brief Title:
7-Hydroxystaurosporine and Irinotecan Hydrochloride in Treating Patients With Metastatic or Unresectable Solid Tumors or Triple Negative Breast Cancer Currently Accruing Only Triple-negative Breast Cancer Patients Since 682007
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Study of UCN-01 in Combination With Irinotecan in Resistant Solid Tumor Malignancies Part I and in Triple Negative ER-Negative PgR-Negative HER-2 Not-Amplified Recurrent Breast Cancers Part II
Status:
COMPLETED
Status Verified Date:
2013-09
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:
This phase I trial is studying the side effects and best dose of giving 7-hydroxystaurosporine together with irinotecan hydrochloride in treating patients with metastatic or unresectable solid tumors including triple-negative breast cancer currently enrolling only patients with triple-negative breast cancer since 682007 Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Giving 7-hydroxystaurosporine together with irinotecan hydrochloride may help kill more cancer cells by making tumor cells more sensitive to the drug
Detailed Description:
PRIMARY OBJECTIVES
I Determine the maximum tolerated dose of UCN-01 7-hydroxystaurosporine and irinotecan irinotecan hydrochloride in patients with resistant solid tumors Part I closed to accrual as of 682007 II Determine the dose-limiting toxicity of this regimen in these patients Part I closed to accrual as of 682007 III Determine the types of toxic effects of this regimen in these patients Part I closed to accrual as of 682007 IV Determine the anti-tumor activity in terms of overall response rate partial response PR and complete response CR clinical benefit rate PR CR and stable disease and time to disease progression in patients with estrogen receptor-negative progesterone receptor-negative and HER-2 not amplified triple negative locally recurrent or metastatic breast cancer treated with this regimen Part II V Determine the side effect profile of this regimen in patients with triple negative recurrent breast cancer Part II
SECONDARY OBJECTIVES
I Determine any anti-tumor activity of this regimen in these patients Part I closed to accrual as of 682007 II Determine the pharmacokinetics of this regimen in these patients Part I closed to accrual as of 682007 III Determine the activity of the serum α-acid glycoprotein and correlate this level with free UCN-01 concentrations Part I closed to accrual as of 682007 IV Determine the in vivo mechanisms of UCN-01 activity in these patients
OUTLINE This is a dose-escalation study
PART I Patients receive irinotecan hydrochloride intravenously IV over 90 minutes on days 1 8 15 and 22 and 7-hydroxystaurosporine IV over 3 hours on days 2 and 23 Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of irinotecan hydrochloride and 7-hydroxystaurosporine 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 Blood samples are collected periodically during study treatment
PART II treatment of triple negative recurrent breast cancer Patients receive irinotecan hydrochloride IV and 7-hydroxystaurosporine IV as in part I at the MTD and undergo blood sample collection
I Determine the maximum tolerated dose of UCN-01 7-hydroxystaurosporine and irinotecan irinotecan hydrochloride in patients with resistant solid tumors Part I closed to accrual as of 682007 II Determine the dose-limiting toxicity of this regimen in these patients Part I closed to accrual as of 682007 III Determine the types of toxic effects of this regimen in these patients Part I closed to accrual as of 682007 IV Determine the anti-tumor activity in terms of overall response rate partial response PR and complete response CR clinical benefit rate PR CR and stable disease and time to disease progression in patients with estrogen receptor-negative progesterone receptor-negative and HER-2 not amplified triple negative locally recurrent or metastatic breast cancer treated with this regimen Part II V Determine the side effect profile of this regimen in patients with triple negative recurrent breast cancer Part II
SECONDARY OBJECTIVES
I Determine any anti-tumor activity of this regimen in these patients Part I closed to accrual as of 682007 II Determine the pharmacokinetics of this regimen in these patients Part I closed to accrual as of 682007 III Determine the activity of the serum α-acid glycoprotein and correlate this level with free UCN-01 concentrations Part I closed to accrual as of 682007 IV Determine the in vivo mechanisms of UCN-01 activity in these patients
OUTLINE This is a dose-escalation study
PART I Patients receive irinotecan hydrochloride intravenously IV over 90 minutes on days 1 8 15 and 22 and 7-hydroxystaurosporine IV over 3 hours on days 2 and 23 Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of irinotecan hydrochloride and 7-hydroxystaurosporine 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 Blood samples are collected periodically during study treatment
PART II treatment of triple negative recurrent breast cancer Patients receive irinotecan hydrochloride IV and 7-hydroxystaurosporine IV as in part I at the MTD and undergo blood sample collection
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-2009-00019 | REGISTRY | None | None |
| NCI-5582 | None | None | None |
| WUSM-SCC-0102 | None | None | None |
| CDR0000069215 | None | None | None |
| UVACC-SCC-0102 | None | None | None |
| SCC 01-02 | OTHER | None | None |
| 5582 | OTHER | None | None |
| P30CA044579 | NIH | CTEP | httpsreporternihgovquickSearchP30CA044579 |