Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00008073
Status:
COMPLETED
Last Update Posted:
2013-12-19
First Post:
2001-01-06
Brief Title:
Octreotide and Doxorubicin in Treating Patients With Advanced Cancer
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Phase I Study Of Octreotide Acetate Sandostatin SMS As A Biomodulator Of Doxorubicin DOX
Status:
COMPLETED
Status Verified Date:
2013-12
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 Octreotide may help doxorubicin kill more cancer cells by making tumor cells more sensitive to the drug
PURPOSE Phase I trial to study the effectiveness of octreotide and doxorubicin in treating patients who have advanced cancer
PURPOSE Phase I trial to study the effectiveness of octreotide and doxorubicin in treating patients who have advanced cancer
Detailed Description:
OBJECTIVES I Determine the toxicity and maximum tolerated dose of octreotide administered with doxorubicin in patients with advanced cancer II Determine the pharmacokinetics and pharmacodynamics of this treatment regimen in these patients
OUTLINE This is a dose escalation study of octreotide Patients receive doxorubicin IV over 5 minutes on day 1 of course 1 For all subsequent courses patients receive octreotide SC continuously on days 1-7 and doxorubicin IV over 5 minutes on day 5 Treatment continues every 3 weeks in the absence of disease progression or unacceptable toxicity Patients with stable or responsive disease after 3 courses of therapy receive a maximum of 6 additional courses Cohorts of 3-6 patients receive escalating doses of octreotide until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity
PROJECTED ACCRUAL Approximately 21-30 patients will be accrued for this study
OUTLINE This is a dose escalation study of octreotide Patients receive doxorubicin IV over 5 minutes on day 1 of course 1 For all subsequent courses patients receive octreotide SC continuously on days 1-7 and doxorubicin IV over 5 minutes on day 5 Treatment continues every 3 weeks in the absence of disease progression or unacceptable toxicity Patients with stable or responsive disease after 3 courses of therapy receive a maximum of 6 additional courses Cohorts of 3-6 patients receive escalating doses of octreotide until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity
PROJECTED ACCRUAL Approximately 21-30 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-G00-1886 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000068373 | REGISTRY | None | None |
| PCI-IRB-951264 | None | None | None |