Pemetrexed (Alimta) in Patients With Head and Neck Squamous Cell Cancer
NCT ID: NCT00507858
Last Updated: 2011-09-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
36 participants
INTERVENTIONAL
2005-09-30
2011-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
* 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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Pemetrexed
Starting dose 500 mg/m\^2 IV once every 3 weeks
Pemetrexed
Starting dose of 500 mg/m\^2 IV Once Over 10 Minutes Every 3 Weeks
Pemetrexed + IV Dexamethasone
Pemetrexed Starting dose 500 mg/m\^2 IV once every 3 weeks + Dexamethasone 20 mg intravenous (IV) Day 1.
Pemetrexed
Starting dose of 500 mg/m\^2 IV Once Over 10 Minutes Every 3 Weeks
Dexamethasone
Arm 2 = 20 mg IV On Day 1; Arm 3 = 4 mg oral (PO) Twice Daily for 3 Days
Pemetrexed + Oral Dexamethasone
Pemetrexed starting dose 500 mg/m\^2 IV once every 3 weeks + Dexamethasone 4 mg orally twice daily for 3 Days.
Pemetrexed
Starting dose of 500 mg/m\^2 IV Once Over 10 Minutes Every 3 Weeks
Dexamethasone
Arm 2 = 20 mg IV On Day 1; Arm 3 = 4 mg oral (PO) Twice Daily for 3 Days
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Pemetrexed
Starting dose of 500 mg/m\^2 IV Once Over 10 Minutes Every 3 Weeks
Dexamethasone
Arm 2 = 20 mg IV On Day 1; Arm 3 = 4 mg oral (PO) Twice Daily for 3 Days
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>/= 20 mm with conventional techniques or as \>/= 10 mm with spiral CT scan.
3. Patients have received one or more chemotherapy regimens.
4. Age \>/= 18 years.
5. Life expectancy of greater than 3 months.
6. No acute intercurrent illness or infection.
7. ECOG performance status \</= 2 (Karnofsky \>/= 60%)
8. Laboratory parameters: white blood count (WBC) \>3,000/mL; Neutrophils \>1,500/mL; Hemoglobin \>8g/dL; Platelets \>100,000/mL; Bilirubin \<1.5 times the upper limit of normal (ULN); Serum creatinine: within normal institutional limits; aspartate aminotransferase (AST or SGOT) and alanine aminotransferase (ALT or SGPT) \< 3 times institutional ULN if alkaline phosphatase is \< ULN, except in known hepatic metastasis, wherein ALT/AST may be \</= 5 times ULN
9. Creatinine clearance: The standard Cockcroft and Gault formula or the measured glomerular filtration rate (GFR) using the appropriate radiolabeled method (51-CrEDTA or Tc99m-DTPA) must be used to calculate CrCl for enrollment or dosing. The same method used at baseline should be used throughout the study. No dosage adjustment is needed in patients with CrCl \>/= 45 mL/min.
10. Patients with a history of non-melanoma skin cancer, or other malignancies treated 5 years or more prior to the current tumor, from which the patient has remained continually disease-free, are eligible.
11. Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria
2. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
3. Patients who are receiving any other investigational agents
4. Patients who have known brain metastases
5. Patients who have signs or symptoms of acute infection requiring systemic therapy.
6. Patients having a history of non-melanoma skin cancer, or other malignancies, treated less than 5 years or more prior to the current tumor
7. Patients requiring total parental nutrition with lipids.
8. Patients exhibiting confusion, disorientation, or having a history of major psychiatric illness that may impair the understanding of the informed consent.
9. Patients refusing to sign the informed consent.
10. Histology other than squamous cell carcinoma.
11. Inability or unwillingness to take folic acid or vitamin B12 supplementation
12. Inability to take corticosteroids
13. Inability to interrupt aspirin or other nonsteroidal anti-inflammatory agents for a 5-day period (for short-acting NSAIDs) or 8-day period (for long-acting NSAIDs, such as piroxicam).
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Eli Lilly and Company
INDUSTRY
M.D. Anderson Cancer Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Edward Kim, MD
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
UT MD Anderson Cancer Center
Houston, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
UT MD Anderson Cancer Center website
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2005-0082
Identifier Type: -
Identifier Source: org_study_id