Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00083057
Status:
COMPLETED
Last Update Posted:
2012-03-15
First Post:
2004-05-14
Brief Title:
Gefitinib Paclitaxel and Radiation Therapy in Treating Patients With Advanced or Recurrent Squamous Cell Carcinoma of the Head and Neck
Sponsor:
National Institutes of Health Clinical Center CC
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Pilot Phase I Dose Escalation Study Of The EGFR Tyrosine Kinase Inhibitor Gefitinib Iressa Combined With Paclitaxel Taxol And External Beam Radiation Therapy In Patients With Advanced Squamous Cell Carcinoma Of The Head And Neck SCCHN
Status:
COMPLETED
Status Verified Date:
2012-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth Drugs used in chemotherapy such as paclitaxel work in different ways to stop tumor cells from dividing so they stop growing or die Radiation therapy uses high-energy x-rays to damage tumor cells Giving gefitinib and paclitaxel together with radiation therapy may kill more tumor cells
PURPOSE This phase I trial is studying the side effects and best dose of gefitinib and paclitaxel when given together with radiation therapy in treating patients with advanced or recurrent squamous cell carcinoma cancer of the head and neck
PURPOSE This phase I trial is studying the side effects and best dose of gefitinib and paclitaxel when given together with radiation therapy in treating patients with advanced or recurrent squamous cell carcinoma cancer of the head and neck
Detailed Description:
OBJECTIVES
Primary
Determine the dose-limiting toxicity toxicity profile and maximum tolerated dose MTD of gefitinib and paclitaxel administered with radiotherapy in patients with advanced or recurrent squamous cell carcinoma of the head and neck
Secondary
Determine the efficacy of this regimen in patients treated at the MTD
OUTLINE This is a pilot dose-escalation study of gefitinib and paclitaxel
Patients receive oral gefitinib once daily beginning on day 1 and continuing until completion of radiotherapy Patients receive paclitaxel IV over 1 hour on days 8 15 22 29 36 and 43 and undergo radiotherapy once daily on days 8-12 15-19 22-26 29-33 36-40 43-47 50-54 and 57-61 Treatment continues in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of gefitinib and paclitaxel 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 A cohort of 6 additional patients receive treatment at the MTD
Patients are followed monthly for 1 year every 2 months for 1 year and then every 3 months for 3 years
PROJECTED ACCRUAL A total of 15-30 patients will be accrued for this study within 2 years
Primary
Determine the dose-limiting toxicity toxicity profile and maximum tolerated dose MTD of gefitinib and paclitaxel administered with radiotherapy in patients with advanced or recurrent squamous cell carcinoma of the head and neck
Secondary
Determine the efficacy of this regimen in patients treated at the MTD
OUTLINE This is a pilot dose-escalation study of gefitinib and paclitaxel
Patients receive oral gefitinib once daily beginning on day 1 and continuing until completion of radiotherapy Patients receive paclitaxel IV over 1 hour on days 8 15 22 29 36 and 43 and undergo radiotherapy once daily on days 8-12 15-19 22-26 29-33 36-40 43-47 50-54 and 57-61 Treatment continues in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of gefitinib and paclitaxel 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 A cohort of 6 additional patients receive treatment at the MTD
Patients are followed monthly for 1 year every 2 months for 1 year and then every 3 months for 3 years
PROJECTED ACCRUAL A total of 15-30 patients will be accrued for this study within 2 years
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 |
|---|---|---|---|
| CDR0000362055 | None | None | None |
| 04-C-0141 | None | None | None |