Ignite Creation Date:
2025-12-25 @ 12:18 AM
Ignite Modification Date:
2026-03-26 @ 4:23 PM
Study NCT ID:
NCT00507858
Status:
COMPLETED
Last Update Posted:
2011-09-23
First Post:
2007-07-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pemetrexed (Alimta) in Patients With Head and Neck Squamous Cell Cancer
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
A Phase I Dose Escalation Study of Pemetrexed in Patients With Advanced Head and Neck Squamous Cell Cancer
Status:
COMPLETED
Status Verified Date:
2011-09
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:
Primary Objective:
* To determine the maximum tolerated doses (MTDs) of pemetrexed when given with dexamethasone. (Please note: One of the three treatment groups will not receive dexamethasone)
Secondary Objectives:
* To assess dose limiting toxicity (DLT), which is defined as grade 4 neutropenia \> 7 days duration, neutropenic fever, grade 4 thrombocytopenia, or any grade 3 or 4 non-hematologic toxicity excluding nausea/vomiting and excluding grade 3 transaminase toxicity.
* To determine objective response rate, as defined as complete response (CR) or partial response (PR), confirmed by 2 CT scans at least 6 weeks apart in patients treated with pemetrexed as a single agent with advanced squamous cell carcinoma of the head and neck.
* To determine the maximum tolerated doses (MTDs) of pemetrexed when given with dexamethasone. (Please note: One of the three treatment groups will not receive dexamethasone)
Secondary Objectives:
* To assess dose limiting toxicity (DLT), which is defined as grade 4 neutropenia \> 7 days duration, neutropenic fever, grade 4 thrombocytopenia, or any grade 3 or 4 non-hematologic toxicity excluding nausea/vomiting and excluding grade 3 transaminase toxicity.
* To determine objective response rate, as defined as complete response (CR) or partial response (PR), confirmed by 2 CT scans at least 6 weeks apart in patients treated with pemetrexed as a single agent with advanced squamous cell carcinoma of the head and neck.
Detailed Description:
Pemetrexed is designed to block enzymes in the body that are important for tumor growth.
If you are found to be eligible to take part in this study, you will be assigned to one of 3 groups. All participants will receive pemetrexed once every 3 weeks through a needle in the vein over about 10 minutes. Every 3 weeks is considered 1 cycle. Participants in Group 1 will receive pemetrexed only. Participants in Group 2 will also receive dexamethasone on Day 1 of each cycle through a needle in the vein. Participants in Group 3 will take dexamethasone by mouth the day before, the day of, and the day after receiving pemetrexed.
Three (3) different dose levels of pemetrexed will be studied. The first group of 6 participants will be treated at Dose Level 1 (lowest of the 3 doses) and evaluated for 3 weeks. If 0 or 1 out of 6 participants experience severe side effects at Dose Level 1, the next group of 6 participants will be treated at Dose Level 2. At any given dose, if greater than 1 out of 6 participants experience severe side effects, then no further participants will receive that dose or a higher dose.
Every 3 weeks (each cycle), you will have a physical exam, including measurement of vital signs (temperature, pulse, breathing rate, and blood pressure) and weight. Blood (about 3-4 teaspoons) will be collected for routine tests. A performance status evaluation (a test looking at the ability to perform everyday activities) and a liver function test will also be done. Your tumor will be evaluated by CT scan and chest x-ray every 2 cycles of study treatment.
While on study, you will be required to take folic acid by mouth every day for 5-7 days before the first dose of pemetrexed and continuing until 3 weeks after your last dose of pemetrexed. You will also receive an injection of vitamin B12 into your muscle 1 to 2 weeks before your first dose of pemetrexed. The vitamin B12 injection will be repeated every 9 weeks until 3 weeks after your last dose of pemetrexed. It is very important that folic acid and vitamin B12 be given to decrease the risk of severe side effects from the pemetrexed.
You may receive up to 6 cycles of treatment. You will be taken off study if the disease gets worse or intolerable side effects occur. When you stop taking study drug on this study, you will have a physical exam, including measurement of vital signs (temperature, pulse, breathing rate, and blood pressure) and weight. Blood (about 3-4 teaspoons) will be collected for routine tests. A performance status evaluation (a test looking at the ability to perform everyday activities) and a liver function test (about 1-2 teaspoons of blood) will also be done.
After completion of 6 cycles of treatment, you will be asked to return to the clinic for follow-up visits every 2-3 months for standard follow-up.
This is an investigational study. The FDA has approved pemetrexed for the treatment of non-small cell lung cancer. However, the FDA has authorized pemetrexed for research only in the patients with HNSCC. Between 40-50 patients will take part in this study. All will be enrolled at M. D. Anderson.
If you are found to be eligible to take part in this study, you will be assigned to one of 3 groups. All participants will receive pemetrexed once every 3 weeks through a needle in the vein over about 10 minutes. Every 3 weeks is considered 1 cycle. Participants in Group 1 will receive pemetrexed only. Participants in Group 2 will also receive dexamethasone on Day 1 of each cycle through a needle in the vein. Participants in Group 3 will take dexamethasone by mouth the day before, the day of, and the day after receiving pemetrexed.
Three (3) different dose levels of pemetrexed will be studied. The first group of 6 participants will be treated at Dose Level 1 (lowest of the 3 doses) and evaluated for 3 weeks. If 0 or 1 out of 6 participants experience severe side effects at Dose Level 1, the next group of 6 participants will be treated at Dose Level 2. At any given dose, if greater than 1 out of 6 participants experience severe side effects, then no further participants will receive that dose or a higher dose.
Every 3 weeks (each cycle), you will have a physical exam, including measurement of vital signs (temperature, pulse, breathing rate, and blood pressure) and weight. Blood (about 3-4 teaspoons) will be collected for routine tests. A performance status evaluation (a test looking at the ability to perform everyday activities) and a liver function test will also be done. Your tumor will be evaluated by CT scan and chest x-ray every 2 cycles of study treatment.
While on study, you will be required to take folic acid by mouth every day for 5-7 days before the first dose of pemetrexed and continuing until 3 weeks after your last dose of pemetrexed. You will also receive an injection of vitamin B12 into your muscle 1 to 2 weeks before your first dose of pemetrexed. The vitamin B12 injection will be repeated every 9 weeks until 3 weeks after your last dose of pemetrexed. It is very important that folic acid and vitamin B12 be given to decrease the risk of severe side effects from the pemetrexed.
You may receive up to 6 cycles of treatment. You will be taken off study if the disease gets worse or intolerable side effects occur. When you stop taking study drug on this study, you will have a physical exam, including measurement of vital signs (temperature, pulse, breathing rate, and blood pressure) and weight. Blood (about 3-4 teaspoons) will be collected for routine tests. A performance status evaluation (a test looking at the ability to perform everyday activities) and a liver function test (about 1-2 teaspoons of blood) will also be done.
After completion of 6 cycles of treatment, you will be asked to return to the clinic for follow-up visits every 2-3 months for standard follow-up.
This is an investigational study. The FDA has approved pemetrexed for the treatment of non-small cell lung cancer. However, the FDA has authorized pemetrexed for research only in the patients with HNSCC. Between 40-50 patients will take part in this study. All will be enrolled at M. D. Anderson.
Study Oversight
Has Oversight DMC:
False
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?: