Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00088907
Status:
TERMINATED
Last Update Posted:
2015-05-06
First Post:
2004-08-04
Brief Title:
Phase III Trial Of Docetaxel Versus Docetaxel Plus ZD1839 In Head And Neck Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase III Randomized Placebo Controlled Trial of Docetaxel Versus Docetaxel Plus ZD1839 Iressa Gefitinib in Performance Status 2 or Previously Treated Patients With Recurrent or Metastatic Head and Neck Cancer
Status:
TERMINATED
Status Verified Date:
2013-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
It was unlikely that the primary endpoint would be reached based on the fifth interim analysis results
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 such as docetaxel work in different ways to stop tumor cells from dividing so they stop growing or die Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth Combining docetaxel with gefitinib may kill more tumor cells It is not yet known whether docetaxel is more effective with or without gefitinib in treating head and neck cancer This randomized phase III trial is studying docetaxel and gefitinib to see how well they work compared to docetaxel alone in treating patients with metastatic or locally recurrent head and neck cancer
Detailed Description:
PRIMARY OBJECTIVES
I To determine the survival of poor prognosis patients with recurrentmetastatic squamous cell carcinoma of the head and neck treated with docetaxel with or without ZD1839 Iressa gefitinib
SECONDARY OBJECTIVES
I To determine the time to progression and response rate in poor prognosis patients with recurrentmetastatic squamous cell carcinoma of the head and neck treated with docetaxel with or without ZD1839 Iressa gefitinib
II To correlate the expression and activation status of the epidermal growth factor receptor EGFR signaling pathway with clinical outcome in the above patient population The following specific biomarkers will be measured by immunohistochemistry on paraffin-embedded tumor tissue EGFR p-EGFR AKT p-AKT Transforming growth factor TGF-alpha Ki-67 extracellular-signal-regulated kinase ERK p-ERK p70s6 p- p70s6 and p27
III To evaluate the frequency of common polymorphisms of Cytochrome P450 3A CYP3A and EGFR in this study population and the impact of these polymorphisms on survival time to progression response rate and toxicities
IV To analyze docetaxel and ZD1839 Iressa gefitinib pharmacokinetics and to correlate polymorphisms with pharmacokinetic variability response toxicity and other endpoints
V To evaluate disease-related symptoms and overall quality of life among patients receiving docetaxel only to those receiving docetaxel and ZD1839 Iressa gefitinib
VI To evaluate whether additional clinical benefit associated with ZD1839 Iressa gefitinib can be detected as an improvement in patient-reported symptoms on the FACT Head and Neck Symptom Index FHNSI-10 and GP5
OUTLINE This is a randomized placebo-controlled double-blind multicenter study Patients are stratified according to treatment with prior chemotherapy pretreated vs untreated Eastern Cooperative Oncology Group ECOG performance status 0 vs 1 vs 2 weight loss within the past 6 months 5 vs 5 and prior cetuximab treatment yes or no Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive docetaxel intravenously IV over 30-60 minutes on days 1 8 and 15 and oral placebo once daily on days 1-28
Arm II Patients receive docetaxel as in arm I and oral gefitinib once daily on days 1-28
In both arms courses repeat every 28 days in the absence of disease progression or unacceptable toxicity Patients in arm I who have disease progression may receive single-agent oral gefitinib once daily until further disease progression which is called step 2 in the study
Quality of life is assessed at baseline on days 15 and 28 of course 1 on day 28 of all subsequent courses and at 2-4 weeks after completion of study treatment
Patients are followed every 3 months for 2 years and then every 6 months for 3 years
PROJECTED ACCRUAL A total of 330 patients 165 per treatment arm will be accrued for this study within 315 months
I To determine the survival of poor prognosis patients with recurrentmetastatic squamous cell carcinoma of the head and neck treated with docetaxel with or without ZD1839 Iressa gefitinib
SECONDARY OBJECTIVES
I To determine the time to progression and response rate in poor prognosis patients with recurrentmetastatic squamous cell carcinoma of the head and neck treated with docetaxel with or without ZD1839 Iressa gefitinib
II To correlate the expression and activation status of the epidermal growth factor receptor EGFR signaling pathway with clinical outcome in the above patient population The following specific biomarkers will be measured by immunohistochemistry on paraffin-embedded tumor tissue EGFR p-EGFR AKT p-AKT Transforming growth factor TGF-alpha Ki-67 extracellular-signal-regulated kinase ERK p-ERK p70s6 p- p70s6 and p27
III To evaluate the frequency of common polymorphisms of Cytochrome P450 3A CYP3A and EGFR in this study population and the impact of these polymorphisms on survival time to progression response rate and toxicities
IV To analyze docetaxel and ZD1839 Iressa gefitinib pharmacokinetics and to correlate polymorphisms with pharmacokinetic variability response toxicity and other endpoints
V To evaluate disease-related symptoms and overall quality of life among patients receiving docetaxel only to those receiving docetaxel and ZD1839 Iressa gefitinib
VI To evaluate whether additional clinical benefit associated with ZD1839 Iressa gefitinib can be detected as an improvement in patient-reported symptoms on the FACT Head and Neck Symptom Index FHNSI-10 and GP5
OUTLINE This is a randomized placebo-controlled double-blind multicenter study Patients are stratified according to treatment with prior chemotherapy pretreated vs untreated Eastern Cooperative Oncology Group ECOG performance status 0 vs 1 vs 2 weight loss within the past 6 months 5 vs 5 and prior cetuximab treatment yes or no Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive docetaxel intravenously IV over 30-60 minutes on days 1 8 and 15 and oral placebo once daily on days 1-28
Arm II Patients receive docetaxel as in arm I and oral gefitinib once daily on days 1-28
In both arms courses repeat every 28 days in the absence of disease progression or unacceptable toxicity Patients in arm I who have disease progression may receive single-agent oral gefitinib once daily until further disease progression which is called step 2 in the study
Quality of life is assessed at baseline on days 15 and 28 of course 1 on day 28 of all subsequent courses and at 2-4 weeks after completion of study treatment
Patients are followed every 3 months for 2 years and then every 6 months for 3 years
PROJECTED ACCRUAL A total of 330 patients 165 per treatment arm will be accrued for this study within 315 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 |
|---|---|---|---|
| ECOG-E1302 | OTHER | None | None |
| U10CA021115 | NIH | Eastern Cooperative Oncology Group | httpsreporternihgovquickSearchU10CA021115 |