Head and Neck CancerPhase 1NCT00507858
Pemetrexed (Alimta) in Patients With Head and Neck Squamous Cell Cancer
A Phase 1 study testing Pemetrexed and Dexamethasone in people with Head and Neck Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Pemetrexed and Dexamethasone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to Sep 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have histologically or cytologically confirmed metastatic or recurrent head and neck squamous cell carcinoma from the primary lesions and/or lymph nodes of the oral cavity, oropharynx, hypopharynx, or larynx.
- 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.
- Patients have received one or more chemotherapy regimens.
- Age >/= 18 years.
- Life expectancy of greater than 3 months.
- No acute intercurrent illness or infection.
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- ECOG performance status </= 2 (Karnofsky >/= 60%)
- 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
- 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.
- 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.
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Acute intercurrent illness or infection
- 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
- Patients who are receiving any other investigational agents
- Patients who have known brain metastases
- Patients who have signs or symptoms of acute infection requiring systemic therapy.
- Patients having a history of non-melanoma skin cancer, or other malignancies, treated less than 5 years or more prior to the current tumor
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- Patients requiring total parental nutrition with lipids.
- Patients exhibiting confusion, disorientation, or having a history of major psychiatric illness that may impair the understanding of the informed consent.
- Patients refusing to sign the informed consent.
- Histology other than squamous cell carcinoma.
- Inability or unwillingness to take folic acid or vitamin B12 supplementation
- Inability to take corticosteroids
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Dose Escalation Study of Pemetrexed in Patients With Advanced Head and Neck Squamous Cell Cancer
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)
Read more
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.
Read the 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.
- Conditions
- Head and Neck Cancer
- Being tested
- Pemetrexed, Dexamethasone
- Keywords
- Head and Neck Cancer, Squamous Cell Cancer, Alimta, Pemetrexed, Dexamethasone, HNSCC, Decadron
- Medical subject headings
- Head and Neck Neoplasms, Neoplasms, Squamous Cell, Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PemetrexedDrug
Also called Alimta, LY231514, MTA, Multitargeted Antifolate
Starting dose of 500 mg/m^2 IV Once Over 10 Minutes Every 3 Weeks
DexamethasoneDrug
Also called Decadron
Arm 2 = 20 mg IV On Day 1; Arm 3 = 4 mg oral (PO) Twice Daily for 3 Days
| Study group | Role | What they receive |
|---|---|---|
| Pemetrexed | Experimental | Starting dose 500 mg/m^2 IV once every 3 weeks Receives: Drug: Pemetrexed |
| Pemetrexed + IV Dexamethasone | Experimental | Pemetrexed Starting dose 500 mg/m^2 IV once every 3 weeks + Dexamethasone 20 mg intravenous (IV) Day 1. Receives: Drug: Pemetrexed; Drug: Dexamethasone |
| Pemetrexed + Oral Dexamethasone | Experimental | Pemetrexed starting dose 500 mg/m^2 IV once every 3 weeks + Dexamethasone 4 mg orally twice daily for 3 Days. Receives: Drug: Pemetrexed; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD) of Pemetrexed
MTD for pemetrexed within each schedule of dexamethasone is defined as the highest dose level in which less than 2 instances of dose limiting toxicities (DLT) observed out of 6 treated participants.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2007 (estimated)
- Study startSep 2005
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company
- Responsible party
- Sponsor
- Investigators
- Edward Kim, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00507858
- Sponsor's protocol ID
- 2005-0082
- Status last verified
- Sep 2011
- First submitted
- 26 Jul 2007
- Last updated
- 23 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Dose Escalation Study of Pemetrexed in Patients With Advanced Head and Neck Squamous Cell Cancer
- ClinicalTrials.gov ID
- NCT00507858
- Acronym / sponsor ID
- 2005-0082
- Conditions
- Head and Neck Cancer
- Keywords
- Head and Neck Cancer, Squamous Cell Cancer, Alimta, Pemetrexed, Dexamethasone, HNSCC, Decadron
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Eli Lilly and Company
- Study start
- Sep 2005
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 27 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pemetrexed | Experimental | Drug: PemetrexedStarting dose 500 mg/m^2 IV once every 3 weeks |
| Pemetrexed + IV Dexamethasone | Experimental | Drug: Pemetrexed, Drug: DexamethasonePemetrexed Starting dose 500 mg/m^2 IV once every 3 weeks + Dexamethasone 20 mg intravenous (IV) Day 1. |
| Pemetrexed + Oral Dexamethasone | Experimental | Drug: Pemetrexed, Drug: DexamethasonePemetrexed starting dose 500 mg/m^2 IV once every 3 weeks + Dexamethasone 4 mg orally twice daily for 3 Days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients must have histologically or cytologically confirmed metastatic or recurrent head and neck squamous cell carcinoma from the primary lesions and/or lymph nodes of the oral cavity, oropharynx, hypopharynx, or larynx.
- 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.
- Patients have received one or more chemotherapy regimens.
- Age >/= 18 years.
- Life expectancy of greater than 3 months.
Key exclusion criteria (13 listed)
- Acute intercurrent illness or infection
- 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
- Patients who are receiving any other investigational agents
- Patients who have known brain metastases
- Patients who have signs or symptoms of acute infection requiring systemic therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PemetrexedAlso: Alimta, LY231514, MTA, Multitargeted AntifolateStarting dose of 500 mg/m^2 IV Once Over 10 Minutes Every 3 Weeks | Drug | Pemetrexed, Pemetrexed + IV Dexamethasone, Pemetrexed + Oral Dexamethasone |
| DexamethasoneAlso: DecadronArm 2 = 20 mg IV On Day 1; Arm 3 = 4 mg oral (PO) Twice Daily for 3 Days | Drug | Pemetrexed + IV Dexamethasone, Pemetrexed + Oral Dexamethasone |
Primary outcome
Maximum Tolerated Dose (MTD) of Pemetrexed
Time frame: 3 weeks
MTD for pemetrexed within each schedule of dexamethasone is defined as the highest dose level in which less than 2 instances of dose limiting toxicities (DLT) observed out of 6 treated participants.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2011.
- UT MD Anderson Cancer Center websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edward Kim, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pemetrexed and Dexamethasone in people with Head and Neck Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose (MTD) of Pemetrexed (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2011.