Ignite Creation Date:
2025-12-24 @ 2:41 PM
Ignite Modification Date:
2026-01-31 @ 3:55 AM
Study NCT ID:
NCT00541359
Status:
COMPLETED
Last Update Posted:
2017-08-09
First Post:
2007-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bortezomib and Topotecan Hydrochloride in Treating Patients With Advanced Solid Tumors
Sponsor:
City of Hope Medical Center
Organization:
Study Overview
Official Title:
A Phase I Trial of PS-341 in Combination With Topotecan in Advanced Solid Tumor Malignancies
Status:
COMPLETED
Status Verified Date:
2017-08
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 some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as topotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bortezomib together with topotecan hydrochloride may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of topotecan hydrochloride when given together with bortezomib in treating patients with advanced solid tumors.
PURPOSE: This phase I trial is studying the side effects and best dose of topotecan hydrochloride when given together with bortezomib in treating patients with advanced solid tumors.
Detailed Description:
PRIMARY OBJECTIVES:
I. To assess the safety and feasibility of combining PS-341 with topotecan in patients with advanced solid tumor malignancies.
II. To define the maximum tolerated dose (MTD) of topotecan when administered in combination with a fixed dose of PS-341 and to described the toxicities at each dose studied.
III. To evaluate the pharmacokinetics of topotecan when given in combination with PS-341 at MTD.
SECONDARY OBJECTIVES:
I. To perform laboratory correlative studies on patients tissue investigating potential predictors of response.
OUTLINE:
PART I (completed as of 09/06/06; all patients enrolled in study after 09/06/06 are enrolled in part II): Patients receive escalating doses of topotecan hydrochloride IV over 30 minutes on days 1 and 8 followed 6 hours later by bortezomib IV on days 1, 4, 8, and 11. Treatment repeats every 21 days for at least 4 courses in the absence of disease progression or unacceptable toxicity.
PART II: Patients receive bortezomib IV on days 1, 4, 8, and 11 followed 6 hours later by escalating doses of topotecan hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for at least 4 courses in the absence of disease progression or unacceptable toxicity.
In both parts of the study, patients who achieve a response may receive additional courses of treatment.
After completion of study treatment, patients are followed periodically.
I. To assess the safety and feasibility of combining PS-341 with topotecan in patients with advanced solid tumor malignancies.
II. To define the maximum tolerated dose (MTD) of topotecan when administered in combination with a fixed dose of PS-341 and to described the toxicities at each dose studied.
III. To evaluate the pharmacokinetics of topotecan when given in combination with PS-341 at MTD.
SECONDARY OBJECTIVES:
I. To perform laboratory correlative studies on patients tissue investigating potential predictors of response.
OUTLINE:
PART I (completed as of 09/06/06; all patients enrolled in study after 09/06/06 are enrolled in part II): Patients receive escalating doses of topotecan hydrochloride IV over 30 minutes on days 1 and 8 followed 6 hours later by bortezomib IV on days 1, 4, 8, and 11. Treatment repeats every 21 days for at least 4 courses in the absence of disease progression or unacceptable toxicity.
PART II: Patients receive bortezomib IV on days 1, 4, 8, and 11 followed 6 hours later by escalating doses of topotecan hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for at least 4 courses in the absence of disease progression or unacceptable toxicity.
In both parts of the study, patients who achieve a response may receive additional courses of treatment.
After completion of study treatment, patients are followed periodically.
Study Oversight
Has Oversight DMC:
True
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?: