Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00033449
Status:
TERMINATED
Last Update Posted:
2013-01-25
First Post:
2002-04-09
Brief Title:
Gefitinib and Radiation Therapy With or Without Cisplatin in Treating Patients With Stage III or Stage IV Head and Neck Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Study Of ZD 1839 In Combination With Radiation And Chemotherapy In Locally Advanced Squamous Cell Carcinoma Of The Head And Neck
Status:
TERMINATED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Administratively complete
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase I trial is studying the side effects and best dose of gefitinib when given together with radiation therapy with or without cisplatin in treating patients with stage III or stage IV head and neck cancer Biological therapies such as gefitinib may interfere with the growth of tumor cells and slow the growth of cancer Radiation therapy uses high-energy x-rays to damage tumor cells Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining gefitinib and radiation therapy with cisplatin may kill more tumor cells
Detailed Description:
PRIMARY OBJECTIVES
I To establish the safety profile of daily oral administration of ZD1839 Iressa AstraZeneca Inc that can be given with concurrent irradiation alone or combined concurrently with weekly cisplatin in previously untreated patients with locally advanced HNSCC AJCC clinical stage III-IVB deemed not suitable for surgery Hence the maximum-tolerated dose of ZD1839 will be determined
II To delineate and quantitate any dose-dependent local and or systemic toxicities of ZD1839 given concurrently with irradiation or combined concurrently with weekly cisplatin to patients with locally advanced HNSCC AJCC stage III-IVB deemed not suitable for surgery
III To determine the feasibility and toxicity profile of protracted continuous daily dosing of ZD1839 beginning 8 weeks after the completion of the head and neck radiation therapy for a period not to exceed 2 years
SECONDARY OBJECTIVES
I Secondary endpoints will include determination of the response rates relapse-free survival rates and overall survival rates for this group of patients
II To perform correlative studies assessing the biological effects of ZD1839 within the primary tumor
OUTLINE This is a multicenter dose-escalation study of gefitinib
All patients receive oral gefitinib once daily beginning at least 7 days before and continuing throughout radiotherapy or chemoradiotherapy in the absence of disease progression or unacceptable toxicity Patients are entered into 1 of 5 levels
Level I Patients undergo concurrent boost radiotherapy 5 days per week comprising once daily radiotherapy for 35 weeks followed by twice daily radiotherapy for 25 weeks
Level II Patients receive escalated dose of gefitinib and undergo radiotherapy as in level I
Level III Patients receive original dose of gefitinib undergo standard fractionation radiotherapy comprising once daily radiotherapy 5 days per week for 7 weeks and receive cisplatin IV over 30-60 minutes at the beginning of each week of radiotherapy
Level IV Patients receive escalated dose of gefitinib as in level II and undergo radiotherapy and chemotherapy as in level III
Level V Patients receive the maximum tolerated dose MTD of gefitinib radiotherapy 5 days a week for 6 weeks and chemotherapy as in level III
Patients with clinical or radiologic evidence of residual disease are required to undergo neck dissection approximately 8 weeks after completion of radiotherapy or chemoradiotherapy
Patients resume oral gefitinib daily beginning 8 weeks after the completion of radiotherapy or chemoradiotherapy 12 weeks for patients who undergo neck dissection and continuing for 2 years in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients are enrolled sequentially beginning at level I until the MTD of gefitinib is determined The MTD is the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity
Twelve additional patients receive the MTD of gefitinib in combination with radiotherapy with or without cisplatin
Patients are followed every 6 months for at least 5 years
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study
I To establish the safety profile of daily oral administration of ZD1839 Iressa AstraZeneca Inc that can be given with concurrent irradiation alone or combined concurrently with weekly cisplatin in previously untreated patients with locally advanced HNSCC AJCC clinical stage III-IVB deemed not suitable for surgery Hence the maximum-tolerated dose of ZD1839 will be determined
II To delineate and quantitate any dose-dependent local and or systemic toxicities of ZD1839 given concurrently with irradiation or combined concurrently with weekly cisplatin to patients with locally advanced HNSCC AJCC stage III-IVB deemed not suitable for surgery
III To determine the feasibility and toxicity profile of protracted continuous daily dosing of ZD1839 beginning 8 weeks after the completion of the head and neck radiation therapy for a period not to exceed 2 years
SECONDARY OBJECTIVES
I Secondary endpoints will include determination of the response rates relapse-free survival rates and overall survival rates for this group of patients
II To perform correlative studies assessing the biological effects of ZD1839 within the primary tumor
OUTLINE This is a multicenter dose-escalation study of gefitinib
All patients receive oral gefitinib once daily beginning at least 7 days before and continuing throughout radiotherapy or chemoradiotherapy in the absence of disease progression or unacceptable toxicity Patients are entered into 1 of 5 levels
Level I Patients undergo concurrent boost radiotherapy 5 days per week comprising once daily radiotherapy for 35 weeks followed by twice daily radiotherapy for 25 weeks
Level II Patients receive escalated dose of gefitinib and undergo radiotherapy as in level I
Level III Patients receive original dose of gefitinib undergo standard fractionation radiotherapy comprising once daily radiotherapy 5 days per week for 7 weeks and receive cisplatin IV over 30-60 minutes at the beginning of each week of radiotherapy
Level IV Patients receive escalated dose of gefitinib as in level II and undergo radiotherapy and chemotherapy as in level III
Level V Patients receive the maximum tolerated dose MTD of gefitinib radiotherapy 5 days a week for 6 weeks and chemotherapy as in level III
Patients with clinical or radiologic evidence of residual disease are required to undergo neck dissection approximately 8 weeks after completion of radiotherapy or chemoradiotherapy
Patients resume oral gefitinib daily beginning 8 weeks after the completion of radiotherapy or chemoradiotherapy 12 weeks for patients who undergo neck dissection and continuing for 2 years in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients are enrolled sequentially beginning at level I until the MTD of gefitinib is determined The MTD is the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity
Twelve additional patients receive the MTD of gefitinib in combination with radiotherapy with or without cisplatin
Patients are followed every 6 months for at least 5 years
PROJECTED ACCRUAL A total of 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 |
|---|---|---|---|
| CDR0000069284 | REGISTRY | PDQ Physician Data Query | None |
| UCHSC-01460 | None | None | None |