Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00028587
Status:
COMPLETED
Last Update Posted:
2013-01-16
First Post:
2002-01-04
Brief Title:
PS-341 and Combination Chemotherapy in Treating Patients With Advanced Solid Tumors
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I and Pharmacologic Study of the Proteasome Inhibitor PS-341 in Combination With Paclitaxel and Carboplatin in Patients With Advanced Malignancies
Status:
COMPLETED
Status Verified Date:
2013-01
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:
Phase I trial to study the effectiveness of combining PS-341 and combination chemotherapy in treating patients who have advanced solid tumors PS-341 may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining PS-341 and chemotherapy may kill more tumor cells
Detailed Description:
PRIMARY OBJECTIVES
I Determine the maximum tolerated dose of bortezomib and paclitaxel administered in combination with carboplatin in patients with advanced solid tumors
II Compare the tolerability and efficacy of the different sequences of this regimen in these patients
III Determine the clinical toxic effects and pharmacokinetics of this regimen in these patients
IV Determine preliminarily the therapeutic activity of this regimen in these patients
V Evaluate p53 accumulation as a marker of PS-341 activity and the effect of paclitaxelcarboplatin on PS-341 induced accumulation of p53
VI Exam the effect of PS-341 on the levels of other proteasome targets eg mdm2 p27 p21 cyclins B D1E IκB and other ubiquitinated proteins in tumor tissue when available
OUTLINE This is a dose-escalation study of bortezomib and paclitaxel Patients are assigned to 1 of 2 treatment groups
Group A Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 and bortezomib IV over 3-5 seconds on days 2 5 and 8
Group B Patients receive bortezomib IV over 3-5 seconds on days 1 4 and 8 and paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 2
Treatment in both groups repeats every 3 weeks in the absence of disease progression or unacceptable toxicity After 6 courses of paclitaxel and carboplatin patients with stable or responding disease may continue with bortezomib alone at the discretion of the investigator Cohorts of 3-6 patients in each group receive escalating doses of bortezomib and paclitaxel until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity
Patients are followed at 3 months
PROJECTED ACCRUAL A total of 24-96 patients will be accrued for this study within 25 months
I Determine the maximum tolerated dose of bortezomib and paclitaxel administered in combination with carboplatin in patients with advanced solid tumors
II Compare the tolerability and efficacy of the different sequences of this regimen in these patients
III Determine the clinical toxic effects and pharmacokinetics of this regimen in these patients
IV Determine preliminarily the therapeutic activity of this regimen in these patients
V Evaluate p53 accumulation as a marker of PS-341 activity and the effect of paclitaxelcarboplatin on PS-341 induced accumulation of p53
VI Exam the effect of PS-341 on the levels of other proteasome targets eg mdm2 p27 p21 cyclins B D1E IκB and other ubiquitinated proteins in tumor tissue when available
OUTLINE This is a dose-escalation study of bortezomib and paclitaxel Patients are assigned to 1 of 2 treatment groups
Group A Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 and bortezomib IV over 3-5 seconds on days 2 5 and 8
Group B Patients receive bortezomib IV over 3-5 seconds on days 1 4 and 8 and paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 2
Treatment in both groups repeats every 3 weeks in the absence of disease progression or unacceptable toxicity After 6 courses of paclitaxel and carboplatin patients with stable or responding disease may continue with bortezomib alone at the discretion of the investigator Cohorts of 3-6 patients in each group receive escalating doses of bortezomib and paclitaxel until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity
Patients are followed at 3 months
PROJECTED ACCRUAL A total of 24-96 patients will be accrued for this study within 25 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 |
|---|---|---|---|
| MC0012 | None | None | None |
| CDR0000069108 | REGISTRY | PDQ Physician Data Query | None |