Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00068497
Status:
COMPLETED
Last Update Posted:
2013-01-14
First Post:
2003-09-10
Brief Title:
Gefitinib in Treating Patients With Metastatic or Unresectable Head and Neck Cancer or Non-Small Cell Lung Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Single Agent ZD-1839 NSC-715055 IND-61187 in Patients With Advanced Head and Neck Carcinoma or Non-Small Cell Lung Cancer Aged 75 Years and Older and in a Cohort of Patients 50 Years Old and Younger
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:
This phase I trial is studying the side effects of gefitinib in treating patients with metastatic or unresectable head and neck cancer or non-small cell lung cancer Gefitinib may stop the growth of cancer cells by blocking the enzymes necessary for their growth
Detailed Description:
PRIMARY OBJECTIVES
I To assess the feasibility of enrolling patients ages 75 years or older and 50 years and younger with metastatic or unresectable head and neck cancer or non-small cell lung cancer to a structured pilot study that includes pharmacokinetic sampling in a special patient population
II To preliminarily compare the ZD-1839 peak concentration level elimination half-life and steady state level between the two patient age groups
OUTLINE This is a pilot multicenter study Patients are stratified according to age 75 years and over vs 50 years and under
Patients receive oral gefitinib on day 1 and then daily beginning on day 8 Treatment continues in the absence of disease progression or unacceptable toxicity
Patients are followed for 30 days and then for up to 3 years after study registration
I To assess the feasibility of enrolling patients ages 75 years or older and 50 years and younger with metastatic or unresectable head and neck cancer or non-small cell lung cancer to a structured pilot study that includes pharmacokinetic sampling in a special patient population
II To preliminarily compare the ZD-1839 peak concentration level elimination half-life and steady state level between the two patient age groups
OUTLINE This is a pilot multicenter study Patients are stratified according to age 75 years and over vs 50 years and under
Patients receive oral gefitinib on day 1 and then daily beginning on day 8 Treatment continues in the absence of disease progression or unacceptable toxicity
Patients are followed for 30 days and then for up to 3 years after study registration
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 |
|---|---|---|---|
| CDR0000322890 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchU10CA032102 |
| S0322 | None | None | None |
| U10CA032102 | NIH | None | None |