Head and Neck CancerPhase 2NCT00589667
A Phase II Study of Pemetrexed Plus Gemcitabine for Metastatic/Recurrent Head and Neck Cancer (HNSCC)
A Phase 2 study testing Pemetrexed plus Gemcitabine in people with Head and Neck Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to determine if the combination of 2 chemotherapy drugs called pemetrexed and gemcitabine might be effective treatment for head and neck squamous cell cancer. The researchers want to find out what effects, good and/or bad, that this treatment has on head and neck cancer. 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 plus Gemcitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to Jul 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 microscopically confirmed epidermoid/squamous cell carcinoma (HNSCC) of the oral cavity, pharynx, larynx, paranasal sinus, or head/neck squamous cell carcinoma unknown primary.
- Patients must have recurrent or metastatic disease which is not amenable to curative-intent therapy with surgery or radiation.
- No more than 2 prior cytotoxic therapies in the recurrent or metastatic disease setting are permitted.
- Patients must be at least 18 years of age.
- Karnofsky Performance status must be ≥ 70%.
- Disease must be measurable by RECIST criteria.
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- At least 4 weeks must have elapsed from previous radiation therapy. Patient must have recovered from the acute toxic effects of treatment prior to study enrollment.
- Prior radiation therapy to ≤ 25% of bone marrow is allowed. Prior radiation to the whole pelvis and/or brain is not allowed.
- Adequate organ function
- Patients of childbearing potential must have a negative test for pregnancy at time of enrollment based on a urine or serum pregnancy test. Patients must agree to use a reliable method of birth control during and for 3 months following the last dose of study drug.
- Patient must reside in geographic proximity to MSKCC for adequate follow-up during treatment, per investigator discretion.
- Patients must sign an informed consent document.
Who cannot join
- Previous exposure to pemetrexed (Alimta) or gemcitabine (Gemzar).
- Pregnancy or breast-feeding.
- Serious concomitant systemic disorders (for example, active infection) that, in the opinion of the investigator, would compromise the safety of the patient or compromise the patient's ability to complete the study.
- History of any brain metastases.
- Inability or unwillingness to take folic acid, vitamin B12 supplementation, or dexamethasone.
- Patients will be excluded if they will be unable to hold use of nonsteroidal antiinflammatory agents (NSAIDS) with short elimination half lives
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
About this study
The purpose of this study is to determine if the combination of 2 chemotherapy drugs called pemetrexed and gemcitabine might be effective treatment for head and neck squamous cell cancer. The researchers want to find out what effects, good and/or bad, that this treatment has on head and neck cancer.
Read the detailed description
Pemetrexed (500 mg/m2) and gemcitabine (1250 mg/m2) will be given together on Days 1 and 15 of a 28 day cycle in patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). Patients will not have received more than 2 prior chemotherapy regimens in the recurrent/metastatic disease setting. Vitamin B12 and folate supplementation will be administered per standard guidelines for pemetrexed chemotherapy.
The primary endpoint is the objective radiologic response rate. Radiologic imaging of evaluable disease will take place after every 2 cycles. Patients may remain on study until progression of disease or unacceptable toxicity.
- Conditions
- Head and Neck Cancer
- Being tested
- Pemetrexed plus Gemcitabine
- Keywords
- Head and Neck Cancer, GEMCITABINE, PEMETREXED, ALTIMA, epidermoid/squamous cell, carcinoma, pharynx, larynx, paranasal sinus, head/neck squamous cell carcinoma
- Medical subject headings
- Head and Neck Neoplasms, Carcinoma, Laryngeal Diseases, 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.
Pemetrexed plus GemcitabineDrug
Also called Alimta, LY231514
Patients will receive pemetrexed (500 mg/m2 IV infusion over approximately 10 minutes) followed immediately by gemcitabine (1250 mg/m2 IV infusion given over approximately 30 minutes) on day 1 and day 15 of a 28-day cycle. Vitamin supplementation will be as follows: Vitamin B12: 1000 µg IM injection no less than 1 week prior to the first dose of pemetrexed, and continuing approximately every 9 weeks until 3 weeks after the last dose of pemetrexed.
Folic acid: The preferred oral daily dose of folic acid is 350 to 1000 µg. Daily folate supplementation begins no less than 1 week prior to the first dose of pemetrexed and continues until 3 weeks after the last dose of pemetrexed.
For rash prophylaxis, dexamethasone (4 mg po twice per day) should be taken on the day before, the day of, and the day after each dose of pemetrexed unless clinical contraindications exist.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Patients will receive pemetrexed (500 mg/m2 IV infusion over approximately 10 minutes) followed immediately by gemcitabine (1250 mg/m2 IV infusion given over approximately 30 minutes) on day 1 and day 15 of a 28-day cycle. Receives: Drug: Pemetrexed plus Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Objective Response
To determine the objective radiologic response rate of pemetrexed and gemcitabine in patients with recurrent or metastatic Head and Neck Squamouse Cell Carcinoma.
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Measured: 2 years
Secondary outcomes (1)
Median Overall Survival
To determine the median overall survival for patients with recurrent or metastatic Head and Neck Squamous Cell Carcinoma treated with pemetrexed and gemcitabine.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2008 (estimated)
- Study startSep 2006
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David G Pfister, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00589667
- Sponsor's protocol ID
- 06-087
- Status last verified
- Mar 2014
- First submitted
- 26 Dec 2007
- Last updated
- 2 Apr 2014
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Pemetrexed Plus Gemcitabine for Metastatic/Recurrent Head and Neck Cancer (HNSCC)
- ClinicalTrials.gov ID
- NCT00589667
- Acronym / sponsor ID
- 06-087
- Conditions
- Head and Neck Cancer
- Keywords
- Head and Neck Cancer, GEMCITABINE, PEMETREXED, ALTIMA, epidermoid/squamous cell, carcinoma, pharynx, larynx
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- Sep 2006
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 10 Jan 2008 (estimated)
- Results
- Posted 5 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if the combination of 2 chemotherapy drugs called pemetrexed and gemcitabine might be effective treatment for head and neck squamous cell cancer. The researchers want to find out what effects, good and/or bad, that this treatment has on head and neck cancer.
Detailed description
Pemetrexed (500 mg/m2) and gemcitabine (1250 mg/m2) will be given together on Days 1 and 15 of a 28 day cycle in patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). Patients will not have received more than 2 prior chemotherapy regimens in the recurrent/metastatic disease setting. Vitamin B12 and folate supplementation will be administered per standard guidelines for pemetrexed chemotherapy.
The primary endpoint is the objective radiologic response rate. Radiologic imaging of evaluable disease will take place after every 2 cycles. Patients may remain on study until progression of disease or unacceptable toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: Pemetrexed plus GemcitabinePatients will receive pemetrexed (500 mg/m2 IV infusion over approximately 10 minutes) followed immediately by gemcitabine (1250 mg/m2 IV infusion given over approximately 30 minutes) on day 1 and day 15 of a 28-day cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients must have microscopically confirmed epidermoid/squamous cell carcinoma (HNSCC) of the oral cavity, pharynx, larynx, paranasal sinus, or head/neck squamous cell carcinoma unknown primary.
- Patients must have recurrent or metastatic disease which is not amenable to curative-intent therapy with surgery or radiation.
- No more than 2 prior cytotoxic therapies in the recurrent or metastatic disease setting are permitted.
- Patients must be at least 18 years of age.
- Karnofsky Performance status must be ≥ 70%.
Key exclusion criteria (6 listed)
- Previous exposure to pemetrexed (Alimta) or gemcitabine (Gemzar).
- Pregnancy or breast-feeding.
- Serious concomitant systemic disorders (for example, active infection) that, in the opinion of the investigator, would compromise the safety of the patient or compromise the patient's ability to complete the study.
- History of any brain metastases.
- Inability or unwillingness to take folic acid, vitamin B12 supplementation, or dexamethasone.
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 |
|---|---|---|
| Pemetrexed plus GemcitabineAlso: Alimta, LY231514Patients will receive pemetrexed (500 mg/m2 IV infusion over approximately 10 minutes) followed immediately by gemcitabine (1250 mg/m2 IV infusion given over approximately 30 minutes) on day 1 and day 15 of a 28-day cycle. Vitamin supplementation will be as follows: Vitamin B12: 1000 µg IM injection no less than 1 week prior to the first dose of pemetrexed, and continuing approximately every 9 weeks until 3 weeks after the last dose of pemetrexed. Folic acid: The preferred oral daily dose of folic acid is 350 to 1000 µg. Daily folate supplementation begins no less than 1 week prior to the first dose of pemetrexed and continues until 3 weeks after the last dose of pemetrexed. For rash prophylaxis, dexamethasone (4 mg po twice per day) should be taken on the day before, the day of, and the day after each dose of pemetrexed unless clinical contraindications exist. | Drug | Treatment |
Primary outcome
Overall Objective Response
Time frame: 2 years
To determine the objective radiologic response rate of pemetrexed and gemcitabine in patients with recurrent or metastatic Head and Neck Squamouse Cell Carcinoma. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
1 secondary outcome
Median Overall Survival
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Memorial Sloan-Kettering web siteLink 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.
David G Pfister, MD principal investigator
Memorial Sloan Kettering 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 2 study testing Pemetrexed plus Gemcitabine in people with Head and Neck Cancer, run by Memorial Sloan Kettering 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 12 inclusion and 6 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 2 Apr 2014. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Overall Objective Response (time frame: 2 years). 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 2 Apr 2014.