Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00049283
Status:
COMPLETED
Last Update Posted:
2014-06-06
First Post:
2002-11-12
Brief Title:
Erlotinib Docetaxel and Radiation Therapy in Treating Patients With Locally Advanced Head and Neck Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Study of the Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor OSI-774 in Combination With Docetaxel and Radiation in Locally Advanced Squamous Cell Cancer of the Head and Neck
Status:
COMPLETED
Status Verified Date:
2013-01
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:
Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth Radiation therapy uses high-energy x-rays to damage tumor cells Combining erlotinib with docetaxel may make the tumor cells more sensitive to radiation therapy and may kill more tumor cells Phase I trial to study the maximum tolerated dose MTD of combining erlotinib with docetaxel and radiation therapy in treating patients who have locally advanced head and neck cancer
Detailed Description:
PRIMARY OBJECTIVES
I Determine MTD and toxicity of combination of EGFR inhibitor OSI-774 docetaxel and radiation
II Pharmacokinetic profile of OSI-774 alone and in combination with docetaxel
SECONDARY OBJECTIVES
I Determine the overall and complete response rate of this combination
II Determine overall disease free and progression free survival of this combination
EGFR expression and phosphorylation status
Serum markers of angiogenic activity VEGF sVEGFR-2 sKIT ICAM PDGF
Fluorescence in situ hybridization FISH for EGFR ERBB2 PDGFR-β for gene amplification
DNA-sequencing of EGFR and ERBB2 genes from DNA extracted from pretreatment biopsy material for mutation screening
Gene expression profiling on pre-treatment biopsy material to identify predictors of response to treatment
Apoptosis TUNEL assay
Ki67 nuclear proliferation antigen
OUTLINE This is a dose-escalation study of erlotinib and docetaxel
Patients receive oral erlotinib alone daily on weeks 1 and 2 Patients then receive oral erlotinib daily beginning on day 1 and docetaxel IV over 1 hour on day 3 of weeks 3-9 Patients also undergo radiotherapy once daily 5 days a week on weeks 3-9 Patients continue erlotinib for up to 2 years in the absence of disease progression or unacceptable toxicity Patients who had N2 or greater cervical lymph node involvement at baseline or have residual neck adenopathy after chemoradiotherapy undergo neck dissection 6-8 weeks after completion of chemoradiotherapy Erlotinib is held for 1 week before planned surgery and until healing is complete
Cohorts of 3-6 patients receive escalating doses of erlotinib and docetaxel until the 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
Patients are followed every 16 weeks for 1 year after completion of erlotinib every 24 weeks for 2 years and then annually thereafter
PROJECTED ACCRUAL Approximately 30 patients will be accrued for this study
I Determine MTD and toxicity of combination of EGFR inhibitor OSI-774 docetaxel and radiation
II Pharmacokinetic profile of OSI-774 alone and in combination with docetaxel
SECONDARY OBJECTIVES
I Determine the overall and complete response rate of this combination
II Determine overall disease free and progression free survival of this combination
EGFR expression and phosphorylation status
Serum markers of angiogenic activity VEGF sVEGFR-2 sKIT ICAM PDGF
Fluorescence in situ hybridization FISH for EGFR ERBB2 PDGFR-β for gene amplification
DNA-sequencing of EGFR and ERBB2 genes from DNA extracted from pretreatment biopsy material for mutation screening
Gene expression profiling on pre-treatment biopsy material to identify predictors of response to treatment
Apoptosis TUNEL assay
Ki67 nuclear proliferation antigen
OUTLINE This is a dose-escalation study of erlotinib and docetaxel
Patients receive oral erlotinib alone daily on weeks 1 and 2 Patients then receive oral erlotinib daily beginning on day 1 and docetaxel IV over 1 hour on day 3 of weeks 3-9 Patients also undergo radiotherapy once daily 5 days a week on weeks 3-9 Patients continue erlotinib for up to 2 years in the absence of disease progression or unacceptable toxicity Patients who had N2 or greater cervical lymph node involvement at baseline or have residual neck adenopathy after chemoradiotherapy undergo neck dissection 6-8 weeks after completion of chemoradiotherapy Erlotinib is held for 1 week before planned surgery and until healing is complete
Cohorts of 3-6 patients receive escalating doses of erlotinib and docetaxel until the 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
Patients are followed every 16 weeks for 1 year after completion of erlotinib every 24 weeks for 2 years and then annually thereafter
PROJECTED ACCRUAL Approximately 30 patients will be accrued for this study
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 |
|---|---|---|---|
| U01CA062502 | NIH | None | httpsreporternihgovquickSearchU01CA062502 |
| CWRU 1301 | None | None | None |
| U01CA099168 | NIH | None | None |