Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00028912
Status:
COMPLETED
Last Update Posted:
2011-04-26
First Post:
2002-01-04
Brief Title:
Bortezomib and Carboplatin in Treating Patients With Recurrent or Progressive Ovarian Epithelial Primary Peritoneal or Fallopian Tube Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase I Trial of Bortezomib NSC 681239 IND58443 and Carboplatin in Recurrent or Progressive Epithelial Ovarian Cancer or Primary Peritoneal Cancer
Status:
COMPLETED
Status Verified Date:
2004-04
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 Bortezomib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth Drugs used in chemotherapy such as carboplatin use different ways to stop tumor cells from dividing so they stop growing or die Bortezomib may help carboplatin kill more tumor cells by making tumor cells more sensitive to the drug
PURPOSE Phase I trial to study the effectiveness of combining bortezomib with carboplatin in treating patients who have recurrent or progressive ovarian epithelial primary peritoneal or fallopian tube cancer
PURPOSE Phase I trial to study the effectiveness of combining bortezomib with carboplatin in treating patients who have recurrent or progressive ovarian epithelial primary peritoneal or fallopian tube cancer
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of bortezomib in combination with carboplatin in patients with recurrent or progressive ovarian epithelial primary peritoneal or fallopian tube cancer
Determine the toxicity of this regimen in these patients
Determine the pharmacodynamics of this regimen in these patients by measurement of 20S proteasome inhibition in whole blood
Correlate toxicity with 20S proteasome inhibition in a whole blood assay in patients treated with this regimen
OUTLINE This is a dose-escalation study of bortezomib
Patients receive carboplatin IV over 30 minutes on days 1 and 8 followed by 1 week of rest during the first course of treatment Beginning with the second course patients receive bortezomib IV on days 1 4 8 and 11 and carboplatin IV over 30 minutes on days 1 and 8 Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of bortezomib 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 8 additional patients are accrued and treated at that dose
PROJECTED ACCRUAL A total of 3-32 patients will be accrued for this study
Determine the maximum tolerated dose of bortezomib in combination with carboplatin in patients with recurrent or progressive ovarian epithelial primary peritoneal or fallopian tube cancer
Determine the toxicity of this regimen in these patients
Determine the pharmacodynamics of this regimen in these patients by measurement of 20S proteasome inhibition in whole blood
Correlate toxicity with 20S proteasome inhibition in a whole blood assay in patients treated with this regimen
OUTLINE This is a dose-escalation study of bortezomib
Patients receive carboplatin IV over 30 minutes on days 1 and 8 followed by 1 week of rest during the first course of treatment Beginning with the second course patients receive bortezomib IV on days 1 4 8 and 11 and carboplatin IV over 30 minutes on days 1 and 8 Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of bortezomib 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 8 additional patients are accrued and treated at that dose
PROJECTED ACCRUAL A total of 3-32 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-5326 | None | None | None |
| MSKCC-01097 | None | None | None |