Ignite Creation Date:
2024-05-05 @ 5:02 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00372736
Status:
COMPLETED
Last Update Posted:
2023-08-04
First Post:
2006-09-06
Brief Title:
AEG35156 and Docetaxel in Treating Patients With Locally Advanced Metastatic or Recurrent Solid Tumors
Sponsor:
NCIC Clinical Trials Group
Organization:
Canadian Cancer Trials Group
Study Overview
Official Title:
A Phase I Study of AEG35156 Given as a 2 Hour Intravenous Infusion in Combination With Docetaxel in Patients With Solid Tumours
Status:
COMPLETED
Status Verified Date:
2020-04
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 Drugs used in chemotherapy such as docetaxel work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing AEG35156 may help docetaxel work better by making tumor cells more sensitive to the drug
PURPOSE This phase I trial is studying the side effects and best dose of AEG35156 when given together with docetaxel in treating patients with locally advanced metastatic or recurrent solid tumors
PURPOSE This phase I trial is studying the side effects and best dose of AEG35156 when given together with docetaxel in treating patients with locally advanced metastatic or recurrent solid tumors
Detailed Description:
OBJECTIVES
Primary
Determine the maximum tolerated dose and define a recommended phase II dose of AEG35156 in combination with docetaxel in patients with locally advanced metastatic or recurrent solid tumors
Secondary
Determine the qualitative and quantitative toxicities of AEG35156 in combination with docetaxel given and define the duration and reversibility of those toxicities
Determine the pharmacokinetic profile of this regimen
Assess preliminarily the antitumor activity of this regimen in these patients
Assess the pharmacodynamic effects of AEG35156 on X-linked inhibitor of apoptosis levels and apoptosis in peripheral blood mononuclear cells and in tumor tissue of these patients
Evaluate M30M65 cytokeratin 18 level a marker of apoptosisnecrosis of epithelial tumors in serum of these patients
OUTLINE This is a multicenter open-label dose-escalation study of AEG35156
Patients receive AEG35156 IV over 2 hours on days -1 0 1 8 and 15 during course 1 and on days 1 8 and 15 of all subsequent courses Patients also receive docetaxel IV over 1 hour on day 1 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 AEG35156 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 Additional patients receive AEG35156 at the recommended phase II dose RPTD
Blood is drawn periodically for pharmacokinetic and pharmacodynamic studies Samples are examined by flow cytometry immunoenzyme methods and reverse transcriptase-polymerase chain reaction for biological markers Tumor tissue archival and fresh is collected from patients treated at the RPTD and examined by immunohistochemical methods and biological marker analysis
After completion of study treatment all patients are followed at 4 weeks Patients with response or stable disease ongoing are followed every 3 months thereafter until relapseprogression Patients with protocol-related toxicity also followed q 3 months until resolution to grade 2
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study
Primary
Determine the maximum tolerated dose and define a recommended phase II dose of AEG35156 in combination with docetaxel in patients with locally advanced metastatic or recurrent solid tumors
Secondary
Determine the qualitative and quantitative toxicities of AEG35156 in combination with docetaxel given and define the duration and reversibility of those toxicities
Determine the pharmacokinetic profile of this regimen
Assess preliminarily the antitumor activity of this regimen in these patients
Assess the pharmacodynamic effects of AEG35156 on X-linked inhibitor of apoptosis levels and apoptosis in peripheral blood mononuclear cells and in tumor tissue of these patients
Evaluate M30M65 cytokeratin 18 level a marker of apoptosisnecrosis of epithelial tumors in serum of these patients
OUTLINE This is a multicenter open-label dose-escalation study of AEG35156
Patients receive AEG35156 IV over 2 hours on days -1 0 1 8 and 15 during course 1 and on days 1 8 and 15 of all subsequent courses Patients also receive docetaxel IV over 1 hour on day 1 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 AEG35156 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 Additional patients receive AEG35156 at the recommended phase II dose RPTD
Blood is drawn periodically for pharmacokinetic and pharmacodynamic studies Samples are examined by flow cytometry immunoenzyme methods and reverse transcriptase-polymerase chain reaction for biological markers Tumor tissue archival and fresh is collected from patients treated at the RPTD and examined by immunohistochemical methods and biological marker analysis
After completion of study treatment all patients are followed at 4 weeks Patients with response or stable disease ongoing are followed every 3 months thereafter until relapseprogression Patients with protocol-related toxicity also followed q 3 months until resolution to grade 2
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| CAN-NCIC-IND166B | OTHER | None | None |
| CDR0000486837 | OTHER | PDQ | None |