A Study for Patients With Head and Neck Cancer
23. června 2011 aktualizováno: Eli Lilly and Company
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.
Přehled studie
Postavení
Dokončeno
Podmínky
Intervence / Léčba
Typ studie
Intervenční
Zápis (Aktuální)
795
Fáze
- Fáze 3
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Buenos Aires, Argentina, C1185AAT
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S.M. De Tucuman, Argentina, 4000
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Santa Fé, Argentina, 3000
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Tucumain, Argentina, 4000
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Antwerp, Belgie, 2020
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Edegem, Belgie, 2650
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Belo Horizonte, Brazílie, 30140-083
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Rio De Janeiro, Brazílie, 20231050
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Aarhus, Dánsko, 8000
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Odense, Dánsko, 5000
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Avignon, Francie, 84082
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Tours, Francie, 37044
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Amsterdam, Holandsko, 1081 HV
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Nijmegen, Holandsko, 6500 HB
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Bangalore, Indie, 560 029
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Bhopal, Indie, 462001
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Hyderabaad, Indie, 500034
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Jaipur, Indie, 302013
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Kochin, Indie, 682304
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Kolkata, Indie, 700053
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New Delhi, Indie, 110 029
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Patna, Indie, 801505
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Pune, Indie, 411004
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Trivandrum, Indie, 695 011
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Confreria, Itálie, 12100
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Genova, Itálie, 16132
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Milano, Itálie, 20133
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Padova, Itálie, 35128
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Bloemfontein, Jižní Afrika, 9300
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Durban, Jižní Afrika, 4091
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Parktown, Jižní Afrika, 2193
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Daegu, Korejská republika, 700-721
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Hwasun-Gun, Korejská republika, 519-809
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Pusan, Korejská republika, 609 735
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Seoul, Korejská republika, 134-791
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Budapest, Maďarsko, 1122
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Nyiregyhaza, Maďarsko, H-4400
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Durango, Mexiko, 34208
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Mexico City, Mexiko, 15900
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Michoacan, Mexiko, 58080
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Monterrey, Mexiko
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Roma Sur, Mexiko, 06760
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Toluca, Mexiko, CP50180
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Berlin, Německo, 13125
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Erlangen, Německo, D-91054
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Essen, Německo, 45122
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Frankfurt, Německo, D-65929
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Hannover, Německo, 30625
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Heidelberg, Německo, 69120
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Leipzig, Německo, 04103
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Luebeck, Německo, 23538
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Gdansk, Polsko, 80-211
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Krakow, Polsko, 31-531
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Olsztyn, Polsko, 10-228
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Warsaw, Polsko, 02-781
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San Juan, Portoriko, 00935
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Bucharest, Rumunsko, 022328
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Cluj-Napoca, Rumunsko, 3400
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Oradea, Rumunsko, 3700
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Targu Mures, Rumunsko, 540136
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Barnaul, Ruská Federace, 656049
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Chelyabinsk, Ruská Federace, 454087
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Moscow, Ruská Federace, 115478
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Murmansk, Ruská Federace, 183047
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Saint Petersburg, Ruská Federace, 198255
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California
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Orange, California, Spojené státy, 92868
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Florida
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Orlando, Florida, Spojené státy, 32806
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St. Petersburg, Florida, Spojené státy, 33708
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Georgia
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Atlanta, Georgia, Spojené státy, 30322
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Illinois
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Chicago, Illinois, Spojené státy, 60637
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Indiana
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Beech Grove, Indiana, Spojené státy, 46107
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Kansas
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Wichita, Kansas, Spojené státy, 67214
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Kentucky
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Louisville, Kentucky, Spojené státy, 40202
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Michigan
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Ann Arbor, Michigan, Spojené státy, 48109
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Minnesota
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Minneapolis, Minnesota, Spojené státy, 55455
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Missouri
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St Louis, Missouri, Spojené státy, 63110
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New York
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Stony Brook, New York, Spojené státy, 11794
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North Carolina
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Chapel Hill, North Carolina, Spojené státy, 27599
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Oklahoma
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Oklahoma City, Oklahoma, Spojené státy, 73112
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Rhode Island
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North Smithfield, Rhode Island, Spojené státy, 02896
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Changhua, Tchaj-wan, 500
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Hualien, Tchaj-wan, 970
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Liouying/Tainan, Tchaj-wan, 736
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Taipei, Tchaj-wan, 112
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Guang Zhou, Čína, 510060
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Nanning, Čína, 530000
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Shanghai, Čína, 200032
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Wu Han, Čína, 430030
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Barcelona, Španělsko, 08036
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Madrid, Španělsko, 28041
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Murcia, Španělsko, 30008
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Pamplona, Španělsko, 31008
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Sevilla, Španělsko, 41013
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Valencia, Španělsko, 46014
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let a starší (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Čtyřnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: Pemetrexed/Cisplatin
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. |
500 mg/m^2, IV, every 21 days, six 21 day cycles
Ostatní jména:
75 mg/m^2, administered IV, every 21 days, six 21 day cycles
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Komparátor placeba: Placebo/Cisplatin
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. |
75 mg/m^2, administered IV, every 21 days, six 21 day cycles
Approximately 100 mL normal saline administered IV, every 21 days, six 21 day cycles
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Overall Survival (OS)
Časové okno: Baseline to date of death from any cause up to 36 months
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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.
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Baseline to date of death from any cause up to 36 months
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Progression-free Survival (PFS)
Časové okno: baseline to measured progressive disease up to 33 months
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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.
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baseline to measured progressive disease up to 33 months
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Percent of Participants With a Tumor Response (Response Rate)
Časové okno: Baseline to progressive disease or discontinuation of study treatment up to 11 months
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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
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Baseline to progressive disease or discontinuation of study treatment up to 11 months
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Duration of Response (DoR)
Časové okno: time of response to progressive disease up to 24 months
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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.
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time of response to progressive disease up to 24 months
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Time to Treatment Worsening in Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Total Score
Časové okno: Baseline (</=Day 1 of first dose) and Day 1 of every subsequent cycle to 30-day post-study completion up to 33 months
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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.
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Baseline (</=Day 1 of first dose) and Day 1 of every subsequent cycle to 30-day post-study completion up to 33 months
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Correlation Between Biomarkers and Treatment Effect
Časové okno: Baseline
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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. |
Baseline
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. prosince 2006
Primární dokončení (Aktuální)
1. března 2010
Dokončení studie (Aktuální)
1. března 2010
Termíny zápisu do studia
První předloženo
20. prosince 2006
První předloženo, které splnilo kritéria kontroly kvality
21. prosince 2006
První zveřejněno (Odhad)
22. prosince 2006
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
28. června 2011
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
23. června 2011
Naposledy ověřeno
1. června 2011
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 8431
- H3E-MC-JMHR (Jiný identifikátor: Eli Lilly and Company)
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .