Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00055770
Status:
COMPLETED
Last Update Posted:
2013-11-25
First Post:
2003-03-06
Brief Title:
Erlotinib Plus Docetaxel in Treating Patients With Locally Advanced Metastatic or Recurrent Head and Neck Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I and Phase II Study of OSI-774 in Combination With Docetaxel in Squamous Cell Carcinoma of the Head and Neck
Status:
COMPLETED
Status Verified Date:
2013-11
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 III trial to study the effectiveness of combining erlotinib with docetaxel in treating patients who have locally advanced recurrent or metastatic head and neck cancer Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die Combining erlotinib with docetaxel may kill more tumor cells
Detailed Description:
OBJECTIVES
I Determine the maximum tolerated dose and dose-limiting toxicity of erlotinib when administered in combination with docetaxel in patients with locally advanced metastatic or recurrent squamous cell carcinoma of the head and neck
II Determine the response rate duration of response time to progression and survival of patients treated with this regimen
III Determine the pharmacokinetics of this regimen in these patients IV Correlate the presence of PTEN RB P-Akt p15 p16 cyclin D1 p27 and p53 genes in tumor tissue with response in patients treated with this regimen
OUTLINE This is a phase I dose-escalation study of erlotinib followed by a phase II study
PHASE I Patients receive oral erlotinib once daily on days 1-28 and docetaxel IV over 1 hour on days 8 15 and 22 Treatment repeats every 28 days for a total of 6 courses in the absence of disease progression or unacceptable toxicity
Patients receive escalating doses of erlotinib until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity Once the MTD is determined an additional cohort of 6 patients receives erlotinib at the MTD
PHASE II Patients receive erlotinib at the MTD and docetaxel as in phase I
I Determine the maximum tolerated dose and dose-limiting toxicity of erlotinib when administered in combination with docetaxel in patients with locally advanced metastatic or recurrent squamous cell carcinoma of the head and neck
II Determine the response rate duration of response time to progression and survival of patients treated with this regimen
III Determine the pharmacokinetics of this regimen in these patients IV Correlate the presence of PTEN RB P-Akt p15 p16 cyclin D1 p27 and p53 genes in tumor tissue with response in patients treated with this regimen
OUTLINE This is a phase I dose-escalation study of erlotinib followed by a phase II study
PHASE I Patients receive oral erlotinib once daily on days 1-28 and docetaxel IV over 1 hour on days 8 15 and 22 Treatment repeats every 28 days for a total of 6 courses in the absence of disease progression or unacceptable toxicity
Patients receive escalating doses of erlotinib until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity Once the MTD is determined an additional cohort of 6 patients receives erlotinib at the MTD
PHASE II Patients receive erlotinib at the MTD and docetaxel as in phase I
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 |
|---|---|---|---|
| U01CA076576 | NIH | CTEP | httpsreporternihgovquickSearchU01CA076576 |
| NCI-2012-01432 | REGISTRY | None | None |
| OSU-0213 | None | None | None |
| NCI-5393 | None | None | None |
| CDR0000271197 | None | None | None |
| OSU-02H0084 | None | None | None |
| OSU 0213 | OTHER | None | None |
| 5393 | OTHER | None | None |