Ignite Creation Date:
2024-05-05 @ 5:13 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00415298
Status:
UNKNOWN
Last Update Posted:
2014-01-10
First Post:
2006-12-20
Brief Title:
AP5346 or Oxaliplatin in Treating Patients With Metastatic andor Unresectable Recurrent Head and Neck Cancer
Sponsor:
University of California San Diego
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
AP5346 for RecurrentUnresectable Squamous Cell Carcinoma of the Head and Neck A Pilot Study With Clinical and Biological Endpoints
Status:
UNKNOWN
Status Verified Date:
2007-05
Last Known Status:
ACTIVE_NOT_RECRUITING
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 AP5346 and oxaliplatin work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing
PURPOSE This randomized clinical trial is studying the dose of AP5346 to see how well it works compared with the dose of oxaliplatin in treating patients with metastatic andor unresectable recurrent head and neck cancer
PURPOSE This randomized clinical trial is studying the dose of AP5346 to see how well it works compared with the dose of oxaliplatin in treating patients with metastatic andor unresectable recurrent head and neck cancer
Detailed Description:
OBJECTIVES
Compare the delivered-dose of platinum per gram of wet weight from a single dose of AP5346 vs a single dose of oxaliplatin in patients with metastatic andor unresectable recurrent squamous cell carcinoma of the head and neck SCCHN
Correlate platinum accumulation in the tumor and tumor DNA with clinical response in patients treated with these regimens
Correlate platinum accumulation in the tumor and tumor DNA with molecular tumor response as determined by GADD153 expression in patients treated with these regimens
Quantify by immunohistochemistry the expression of the copper transporters CTR1 ATP7A and ATP7B in SCCHN tumors and correlate expression of these transporters with tumor platinum levels
Determine response in patients treated with AP5346
Obtain additional data on the safety of AP5346 in these patients
OUTLINE This is a randomized pilot study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive AP5346 IV over 2 hours three times daily on days 1 and 15
Arm II Patients receive a single dose of unmodified oxaliplatin IV over 2 hours on day 1
Beginning on day 29 all patients may receive AP5346 as in arm I Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
Patients undergo tumor biopsy before and 24 hours after the first course of treatment for correlative pharmacological immunohistochemical IHC and molecular studies Tumor specimens are assessed for platinum content GADD153 gene expression by molecular analysis and copper transporter CTR1 ATP7A ATP7B expression by IHC
PROJECTED ACCRUAL A total of 12 patients will be accrued for this study
Compare the delivered-dose of platinum per gram of wet weight from a single dose of AP5346 vs a single dose of oxaliplatin in patients with metastatic andor unresectable recurrent squamous cell carcinoma of the head and neck SCCHN
Correlate platinum accumulation in the tumor and tumor DNA with clinical response in patients treated with these regimens
Correlate platinum accumulation in the tumor and tumor DNA with molecular tumor response as determined by GADD153 expression in patients treated with these regimens
Quantify by immunohistochemistry the expression of the copper transporters CTR1 ATP7A and ATP7B in SCCHN tumors and correlate expression of these transporters with tumor platinum levels
Determine response in patients treated with AP5346
Obtain additional data on the safety of AP5346 in these patients
OUTLINE This is a randomized pilot study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive AP5346 IV over 2 hours three times daily on days 1 and 15
Arm II Patients receive a single dose of unmodified oxaliplatin IV over 2 hours on day 1
Beginning on day 29 all patients may receive AP5346 as in arm I Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
Patients undergo tumor biopsy before and 24 hours after the first course of treatment for correlative pharmacological immunohistochemical IHC and molecular studies Tumor specimens are assessed for platinum content GADD153 gene expression by molecular analysis and copper transporter CTR1 ATP7A ATP7B expression by IHC
PROJECTED ACCRUAL A total of 12 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 |
|---|---|---|---|
| UCSD-HRPP-050275 | None | None | None |