Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005842
Status:
COMPLETED
Last Update Posted:
2013-02-11
First Post:
2000-06-02
Brief Title:
Trastuzumab Plus R115777 in Treating Patients With Advanced or Metastatic Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Pharmacokinetic and Biologic Correlative Study of R115777 NSC 702818 and Herceptin in Patients With Advanced Cancer
Status:
COMPLETED
Status Verified Date:
2007-04
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:
Phase I trial to study the effectiveness of trastuzumab plus R115777 in treating patients who have advanced or metastatic cancer Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining trastuzumab with R115777 may kill more tumor cells
Detailed Description:
OBJECTIVES
I Determine the maximum tolerated dose of R115777 when administered with trastuzumab Herceptin in patients with advanced or metastatic adenocarcinoma
II Assess the toxicities and pharmacokinetics of this treatment regimen in this patient population
III Determine the antitumor activity of this treatment regimen in these patients
IV Determine the relative biologic endpoints of this regimen and correlate them with toxicity and pharmacokinetic parameters in these patients
OUTLINE This is a dose escalation multicenter study of R115777
Patients receive trastuzumab Herceptin IV over 90 minutes on days 1 8 15 and 22 plus oral R115777 twice daily for 3 weeks Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of R115777 until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which no more than 1 of 6 patients experiences dose limiting toxicities
Patients are followed every 30 days until toxicity resolves
I Determine the maximum tolerated dose of R115777 when administered with trastuzumab Herceptin in patients with advanced or metastatic adenocarcinoma
II Assess the toxicities and pharmacokinetics of this treatment regimen in this patient population
III Determine the antitumor activity of this treatment regimen in these patients
IV Determine the relative biologic endpoints of this regimen and correlate them with toxicity and pharmacokinetic parameters in these patients
OUTLINE This is a dose escalation multicenter study of R115777
Patients receive trastuzumab Herceptin IV over 90 minutes on days 1 8 15 and 22 plus oral R115777 twice daily for 3 weeks Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of R115777 until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which no more than 1 of 6 patients experiences dose limiting toxicities
Patients are followed every 30 days until toxicity resolves
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-62 | None | None | None |
| UTHSC-IDD-99-26 | None | None | None |
| SACI-IDD-99-26 | None | None | None |