Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00030576
Status:
COMPLETED
Last Update Posted:
2018-10-10
First Post:
2002-02-14
Brief Title:
Erlotinib and Cisplatin in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
A Phase III Study Of OSI-774 In Combination With Cisplatin In Patients With Recurrent Or Metastatic Squamous Cell Cancer Of The Head And Neck
Status:
COMPLETED
Status Verified Date:
2018-10
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 Biological therapies such as erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining erlotinib with cisplatin may kill more tumor cells
PURPOSE Phase III trial to study the effectiveness of combining erlotinib and cisplatin in treating patients who have recurrent or metastatic head and neck cancer
PURPOSE Phase III trial to study the effectiveness of combining erlotinib and cisplatin in treating patients who have recurrent or metastatic head and neck cancer
Detailed Description:
OBJECTIVES
Determine the objective response rate in patients with recurrent or metastatic squamous cell cancer of the head and neck treated with erlotinib and cisplatin
Determine the stable disease rates duration of response progression-free survival median survival and overall survival of patients treated with this regimen
Determine the safety and tolerability of this regimen in these patients
Determine the relationship between clinical pharmacokinetic and pharmacodynamic effects of this regimen in these patients
Correlate baseline and post-treatment levels of epidermal growth factor receptor its downstream signaling components and markers of angiogenesis and apoptosis in tumor and skin biopsies with clinical outcome in patients treated with this regimen
OUTLINE This is a dose-escalation multicenter study
Patients receive oral erlotinib once daily on days -6 to 21 for the first course only and cisplatin IV over 60 minutes on day 1 For the second and subsequent courses patients receive oral erlotinib once daily on days 1-21 and cisplatin as in course 1 Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity Patients with stable or responding disease after 6 courses may continue to receive erlotinib alone until disease progression
Cohorts of 3-6 patients receive escalating doses of erlotinib and cisplatin 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 At least 6 patients are treated at the MTD
Patients are followed every 3 months
PROJECTED ACCRUAL A maximum of 43 patients will be accrued for this study within 18 months
Determine the objective response rate in patients with recurrent or metastatic squamous cell cancer of the head and neck treated with erlotinib and cisplatin
Determine the stable disease rates duration of response progression-free survival median survival and overall survival of patients treated with this regimen
Determine the safety and tolerability of this regimen in these patients
Determine the relationship between clinical pharmacokinetic and pharmacodynamic effects of this regimen in these patients
Correlate baseline and post-treatment levels of epidermal growth factor receptor its downstream signaling components and markers of angiogenesis and apoptosis in tumor and skin biopsies with clinical outcome in patients treated with this regimen
OUTLINE This is a dose-escalation multicenter study
Patients receive oral erlotinib once daily on days -6 to 21 for the first course only and cisplatin IV over 60 minutes on day 1 For the second and subsequent courses patients receive oral erlotinib once daily on days 1-21 and cisplatin as in course 1 Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity Patients with stable or responding disease after 6 courses may continue to receive erlotinib alone until disease progression
Cohorts of 3-6 patients receive escalating doses of erlotinib and cisplatin 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 At least 6 patients are treated at the MTD
Patients are followed every 3 months
PROJECTED ACCRUAL A maximum of 43 patients will be accrued for this study within 18 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 |
|---|---|---|---|
| CAN-NCIC-IND157 | None | None | None |
| PMH-PHL-002 | None | None | None |
| NCI-5380 | None | None | None |