Head and Neck NeoplasmsPhase 3NCT00415194
A Study for Patients With Head and Neck Cancer
A Phase 3 study testing pemetrexed and cisplatin in people with Head and Neck Neoplasms, run by Eli Lilly and Company at 94 sites in 21 countries.
Trial summary
This study will compare the effects of pemetrexed plus cisplatin versus cisplatin alone in head and neck cancer patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Neoplasms
- What is being tested?
- pemetrexed and cisplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 795 participants
- Where
- 94 sitesin 21 countries
- Study dates
- Dec 2006to Mar 2010
- Phase
- Phase 3
- 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
- You must have head and neck cancer that has returned and cannot be treated with surgery or other types of treatment. OR You must have head and neck cancer that was just found and has spread to other parts of your body.
- You must have a performance status of 0,1 or 2. This means that you must at least be able to get around, be able to take care of yourself and must be up and about most of the day.
- Your test results must show that your liver, kidneys and blood cells are working normally.
- You must understand and sign the form that gives your agreement to willingly be part of the study.
- You must be at least 18 years of age.
Who cannot join
- You cannot have previously been given other treatment for cancer that has spread to other parts of your body.
- You cannot have a serious sickness that might keep you from finishing the study (for example a bad infection).
- You cannot have any extra fluid in your chest or bowel area unless your doctor tells you it can be drained before you join the study.
- You cannot have any cancer called nasopharyngeal cancer, paranasal sinus cancer, lip cancer, or salivary gland cancer.
- If you are taking high dose aspirin or other medicines called non-steroidal anti-inflammatory drugs and cannot stop taking them for at least 5 days, you cannot be in the study. Your doctor or a member of the study team can explain which drugs are non-steroidal anti-inflammatory drugs.
Trial locations and contacts
94 sites in 21 countries.
94 sites in 21 countries
United States15 sites
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Ann Arbor, Michigan, 48109
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Atlanta, Georgia, 30322
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Beech Grove, Indiana, 46107
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Chapel Hill, North Carolina, 27599
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Chicago, Illinois, 60637
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Louisville, Kentucky, 40202
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Minneapolis, Minnesota, 55455
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North Smithfield, Rhode Island, 02896
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Oklahoma City, Oklahoma, 73112
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Orange, California, 92868
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Orlando, Florida, 32806
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St Louis, Missouri, 63110
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St. Petersburg, Florida, 33708
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Stony Brook, New York, 11794
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Wichita, Kansas, 67214
India10 sites
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Bangalore, 560 029
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Bhopal, 462001
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Hyderabaad, 500034
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Jaipur, 302013
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Kochi, 682304
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Kolkata, 700053
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New Delhi, 110 029
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Patna, 801505
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Pune, 411004
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Trivandrum, 695 011
Germany8 sites
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Berlin, 13125
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Erlangen, D-91054
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Essen, 45122
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Frankfurt, D-65929
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Hanover, 30625
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Heidelberg, 69120
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Leipzig, 04103
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Lübeck, 23538
Mexico6 sites
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Durango, 34208
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Mexico City, 15900
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Michoacán, 58080
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Monterrey
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Roma Sur, 06760
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Toluca, CP50180
Spain6 sites
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Barcelona, 08036
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Madrid, 28041
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Murcia, 30008
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Pamplona, 31008
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Seville, 41013
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Valencia, 46014
Russia5 sites
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Barnaul, 656049
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Chelyabinsk, 454087
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Moscow, 115478
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Murmansk, 183047
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Saint Petersburg, 198255
Argentina4 sites
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Buenos Aires, C1185AAT
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S.M. de Tucuman, 4000
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Santa Fe, 3000
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Tucumain, 4000
China4 sites
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Guangzhou, 510060
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Nanning, 530000
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Shanghai, 200032
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Wuhan, 430030
Italy4 sites
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Confreria, 12100
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Genova, 16132
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Milan, 20133
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Padova, 35128
Poland4 sites
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Gdansk, 80-211
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Krakow, 31-531
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Olsztyn, 10-228
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Warsaw, 02-781
Romania4 sites
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Bucharest, 022328
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Cluj-Napoca, 3400
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Oradea, 3700
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Târgu Mureş, 540136
South Korea4 sites
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Daegu, 700-721
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Hwasun-Gun, 519-809
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Pusan, 609 735
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Seoul, 134-791
Taiwan4 sites
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Changhua, 500
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Hualien City, 970
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Liouying/Tainan, 736
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Taipei, 112
South Africa3 sites
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Bloemfontein, 9300
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Durban, 4091
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Parktown, 2193
Belgium2 sites
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Antwerp, 2020
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Edegem, 2650
Brazil2 sites
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Belo Horizonte, 30140-083
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Rio de Janeiro, 20231050
Denmark2 sites
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Aarhus, 8000
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Odense, 5000
France2 sites
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Avignon, 84082
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Tours, 37044
Hungary2 sites
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Budapest, 1122
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Nyíregyháza, H-4400
Netherlands2 sites
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Amsterdam, 1081 HV
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Nijmegen, 6500 HB
Puerto Rico1 site
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San Juan, 00935
About this study
Official title: A Randomized Phase 3 Study of Pemetrexed in Combination With Cisplatin Versus Cisplatin Monotherapy in Patients With Recurrent or Metastatic Head and Neck Cancer
This study will compare the effects of pemetrexed plus cisplatin versus cisplatin alone in head and neck cancer patients.
- Conditions
- Head and Neck Neoplasms
- Being tested
- pemetrexed, cisplatin, placebo
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pemetrexedDrug
Also called Alimta, LY231514
500 mg/m^2, IV, every 21 days, six 21 day cycles
cisplatinDrug
75 mg/m^2, administered IV, every 21 days, six 21 day cycles
placeboDrug
Approximately 100 mL normal saline administered IV, every 21 days, six 21 day cycles
| Study group | Role | What they receive |
|---|---|---|
| Pemetrexed/Cisplatin | Experimental | Pemetrexed 500 milligrams per meter square (mg/m^2) administered intravenously (IV) plus cisplatin 75 mg/m^2 IV on Day 1 every 21 days. Pretreatment, Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment.
Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose. Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose. Receives: Drug: pemetrexed; Drug: cisplatin |
| Placebo/Cisplatin | Placebo comparator | Placebo (approximately 100 mL normal saline) administered intravenously (IV) plus cisplatin 75 mg/m^2 on Day 1 every 21 days.
Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment. Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose.
Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose. Receives: Drug: cisplatin; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
OS duration is defined as the time from the date of randomization to the date of death from any cause. For each participant who is not known to have died as of the data-inclusion cut-off date, OS duration will be censored at the date of the participant's last contact prior to that cut-off date.
Measured: Baseline to date of death from any cause up to 36 months
Secondary outcomes (5)
Progression-free Survival (PFS)
Objective PFS is defined as the time from date of randomization to date of objectively determined progressive disease (PD) or death from any cause, whichever comes first. PD was defined by Response Evaluation Criteria in Solid Tumors (RECIST). PD=at least a 20% increase in sum of longest diameter of target lesions. For participants who are not known to have died as of the data-inclusion cut-off date, and who do not have progressive disease, PFS will be censored at the date of the last objective progression-free disease assessment prior to the date of any subsequent systemic anticancer therapy.
Measured: baseline to measured progressive disease up to 33 months
Percent of Participants With a Tumor Response (Response Rate)
Tumor Response is evaluated as CR (Complete Response) or PR (Partial Response) per Response Evaluation Criteria in Solid Tumors (RECIST criteria). Possible evaluations include: CR: Disappearance of all target lesions. PR: At least a 30% decrease in the size of target lesions. Response rate (%) = (number of participants with CR+PR/number of participants)*100
Measured: Baseline to progressive disease or discontinuation of study treatment up to 11 months
Duration of Response (DoR)
DoR is time from first observation of complete response (CR) or partial response (PR) to first observation of PD or death. Response is objective status of CR or PR using RECIST criteria. CR is disappearance of lesions. PR is >30% decrease in size of lesions. Responder is any participant with CR or PR. PD is at least 20% increase in sum of longest diameter of target lesions. For participants alive as of data-inclusion cut-off date and who do not have PD, DoR will be censored at date of last objective progression-free disease assessment before date of any subsequent systemic anticancer therapy.
Measured: time of response to progressive disease up to 24 months
Time to Treatment Worsening in Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Total Score
FACT-H\&N consists of 39 items with 5-point rating scale from 0 (not at all) to 4 (very much). FACT-H\&N Total score ranges from 0 to 148. Higher score represents a better quality of life. Time to worsening was defined as the first date of worsening in the FACT H\&N Total score that was considered at least the prospectively defined minimally important difference (MID) as compared with participant's baseline score, or date of death from any cause. The MID for FACT H\&N Total score was a decrease of 12 points.
Measured: Baseline (</=Day 1 of first dose) and Day 1 of every subsequent cycle to 30-day post-study completion up to 33 months
Correlation Between Biomarkers and Treatment Effect
Correlation between highly up/downregulated genes and clinical response (Overall Survival (OS) and Progression-Free Survival (PFS)). OS is is defined as the time from the date of randomization to the date of death from any cause. PFS is defined as the time from the date of randomization to the date of objectively determined progressive disease or death from any cause, whichever comes first.
0 participants were analyzed; Reason: The relatively low number of samples collected would not have yielded a meaningful genomic analysis and the decision was made to not analyze the data.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2006 (estimated)
- Study startDec 2006
- Primary completionMar 2010
- Study completionMar 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 NeoplasmsStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 795 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00415194
- Sponsor's protocol ID
- 8431
- Other IDs
- H3E-MC-JMHR
- Status last verified
- Jun 2011
- First submitted
- 20 Dec 2006
- Last updated
- 28 Jun 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase 3 Study of Pemetrexed in Combination With Cisplatin Versus Cisplatin Monotherapy in Patients With Recurrent or Metastatic Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT00415194
- Acronym / sponsor ID
- 8431
- Conditions
- Head and Neck Neoplasms
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 795 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 22 Dec 2006 (estimated)
- Results
- Posted 6 Apr 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare the effects of pemetrexed plus cisplatin versus cisplatin alone in head and neck cancer patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pemetrexed/Cisplatin | Experimental | Drug: pemetrexed, Drug: cisplatinPemetrexed 500 milligrams per meter square (mg/m^2) administered intravenously (IV) plus cisplatin 75 mg/m^2 IV on Day 1 every 21 days. Pretreatment, Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment. Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose. Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose. |
| Placebo/Cisplatin | Placebo comparator | Drug: cisplatin, Drug: placeboPlacebo (approximately 100 mL normal saline) administered intravenously (IV) plus cisplatin 75 mg/m^2 on Day 1 every 21 days. Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment. Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose. Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- You must have head and neck cancer that has returned and cannot be treated with surgery or other types of treatment. OR You must have head and neck cancer that was just found and has spread to other parts of your body.
- You must have a performance status of 0,1 or 2. This means that you must at least be able to get around, be able to take care of yourself and must be up and about most of the day.
- Your test results must show that your liver, kidneys and blood cells are working normally.
- You must understand and sign the form that gives your agreement to willingly be part of the study.
- You must be at least 18 years of age.
Key exclusion criteria (5 listed)
- You cannot have previously been given other treatment for cancer that has spread to other parts of your body.
- You cannot have a serious sickness that might keep you from finishing the study (for example a bad infection).
- You cannot have any extra fluid in your chest or bowel area unless your doctor tells you it can be drained before you join the study.
- You cannot have any cancer called nasopharyngeal cancer, paranasal sinus cancer, lip cancer, or salivary gland cancer.
- If you are taking high dose aspirin or other medicines called non-steroidal anti-inflammatory drugs and cannot stop taking them for at least 5 days, you cannot be in the study. Your doctor or a member of the study team can explain which drugs are non-steroidal anti-inflammatory drugs.
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, LY231514500 mg/m^2, IV, every 21 days, six 21 day cycles | Drug | Pemetrexed/Cisplatin |
| cisplatin75 mg/m^2, administered IV, every 21 days, six 21 day cycles | Drug | Pemetrexed/Cisplatin, Placebo/Cisplatin |
| placeboApproximately 100 mL normal saline administered IV, every 21 days, six 21 day cycles | Drug | Placebo/Cisplatin |
Primary outcome
Overall Survival (OS)
Time frame: Baseline to date of death from any cause up to 36 months
OS duration is defined as the time from the date of randomization to the date of death from any cause. For each participant who is not known to have died as of the data-inclusion cut-off date, OS duration will be censored at the date of the participant's last contact prior to that cut-off date.
5 secondary outcomes
Progression-free Survival (PFS)
Time frame: baseline to measured progressive disease up to 33 months
Percent of Participants With a Tumor Response (Response Rate)
Time frame: Baseline to progressive disease or discontinuation of study treatment up to 11 months
Duration of Response (DoR)
Time frame: time of response to progressive disease up to 24 months
Time to Treatment Worsening in Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Total Score
Time frame: Baseline (</=Day 1 of first dose) and Day 1 of every subsequent cycle to 30-day post-study completion up to 33 months
Correlation Between Biomarkers and Treatment Effect
Time frame: Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Lilly Clinical Trial RegistryLink 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.
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
94 sites in 21 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing pemetrexed and cisplatin in people with Head and Neck Neoplasms, run by Eli Lilly and Company at 94 sites in 21 countries.
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 5 inclusion and 5 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 28 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 94 sites in United States, India, Germany, Mexico, Spain and 16 more countries. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 6 Apr 2011). 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 Survival (OS) (time frame: Baseline to date of death from any cause up to 36 months). 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 28 Jun 2011.