- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00891579
Study of Pemetrexed Versus Gefitinib in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer Who Have Previously Received Platinum-Based Chemotherapy Without Epidermal Growth Factor Receptor (EGFR) Mutations
7. december 2012 opdateret af: Yi-Long Wu, Chinese Society of Lung Cancer
Phase 2 Randomized, Controlled, Open-label Study of Pemetrexed Versus Gefitinib in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer Who Have Previously Received Platinum-Based Chemotherapy Without EGFR Mutations
This study is a prospective trial of Alimta (pemetrexed) versus IRESSA (gefitinib) among epidermal growth factor receptor wild-type Non-Small Cell Lung Cancer (NSCLC) patients in a 2nd line setting.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
161
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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-
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Beijing, Kina
- 307 hospital of People's Liberation Army
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Beijing, Kina
- Peking Union hospital
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Changchun, Kina
- Jilin Tumor Hospital
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Nanjing, Kina
- Nanjing General Hospital of Nanjing Military Command
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Shanghai, Kina
- Shanghai Chest Hospital
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Shenyang, Kina
- The First Hospital of China Medical University
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Guangdong
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Guangzhou, Guangdong, Kina, 510080
- Lung Cancer Research Institute & Cancer Center of Guangdong General Hospital
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 80 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Informed consent must be signed.
- At least 18 years of age.
- Histologic or cytologic diagnosis of NSCLC.
- Locally advanced or metastatic disease (stage IIIB, or IV) that is not amenable to definitive surgery or radiotherapy.
- Patients must have previously received one platinum-based chemotherapy regimen for palliative therapy of locally advanced or metastatic disease. Patients are also eligible if they have received one platinum-based chemotherapy regimen as neoadjuvant or adjuvant chemotherapy and the disease recurred within six months since the finishing of neoadjuvant or adjuvant chemotherapy.
- Without EGFR mutations.
- At least one measurable lesion as defined by RECIST criteria.
- ECOG PS0 - 2.
Adequate organ function including the following:
- bone marrow;
- hepatic;
- renal.
- Prior chemotherapy must be completed at least 3 weeks prior to the study enrollment, and the patient must have recovered from the toxic effects of the treatment (except for alopecia).
- Previous palliative radiation therapy is allowed, but limited in LESS 25% of the bone marrow and must not have included whole pelvis radiation. Patients must have recovered from the toxic effects of the treatment prior to study enrollment (except for alopecia). Prior radiotherapy must be completed one month before study entry. Radiotherapy should not be administered to target lesions selected for this study, unless progression of the selected target lesions within the radiation portal is documented.
- Estimated life expectancy of at least 8 weeks.
For women:
- must be surgically sterile;
- postmenopausal; OR
- compliant with a medically approved contraceptive regimen during and for 3 months after the treatment period; must have negative serum or urine pregnancy test and must not be lactating.
For men:
- must be surgically sterile; OR
- compliant with a contraceptive regimen during and for 3 months after the treatment period.
- Patient compliance and geographic proximity that allow adequate follow-up.
Exclusion Criteria:
- Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry or concurrent administration of any other anti-tumor therapy.
- Have previously participated in a study involving pemetrexed or EGFR-TKI
- Hypersensitivity to pemetrexed or gefitinib or any ingredients in the two drugs.
- Symptomatic central nervous system (CNS) metastases and asymptomatic CNS metastases requiring concurrent corticosteroid therapy. Treated stable CNS metastases are allowed; the patient must be stable after radiotherapy for more than 2 weeks and off of corticosteroids for more than 1 week. .
- History of another malignancy within the last 5 years except cured carcinoma in-situ of uterine cervix, cured basal cell carcinoma of skin and superficial bladder tumors (Ta, Tis and T1)
- Lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome, or inability to take oral medication, or have active peptic ulcer disease.
- Patients with interstitial lung disease.
- Any unstable systemic disease (including active infection, hepatic, renal or metabolic disease) or serious concomitant disorders that would compromise the safety of the patient, or compromise the patient's ability to complete the study, at the discretion of the investigator.
- Significant cardiovascular event: congestive heart failure >NYHA class 2; unstable angina, active CAD (myocardial infarction more than 1 year prior to study entry is allowed); serious cardiac arrhythmia requiring antiarrythmic therapy ( beta blockers or digoxin are permitted) or uncontrolled hypertension.
- History of significant neurological or mental disorder, including seizures or dementia.
- Incision from operation has not healed before the start of study treatment (Small incision for biopsy is eligible.)
- Pregnant or breast-feeding women and childbearing potential women with either a positive or no pregnancy test within 48 hours of the start of treatment. Postmenopausal women must have been amenorrhoeic for at least 12 months to be considered of non-childbearing potential.
- Concurrent use of St. John's Wort, Rifampicin, and/or ritonavir.
- Inability to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs) 2 days before, the day of, and 2 days after the dose of pemetrexed. If a patient is taking an NSAID (Cox-2 inhibitors included) or salicylate with a long half-life (e.g., naproxen, piroxicam, diflunisal, nabumetone, rofecoxib, or celecoxib) it should not be taken 5 days before, the day of, and 2 days after the dose of pemetrexed.
- Presence of clinically detectable (by physical exam) third-space fluid collections, for example, ascites or pleural effusions that cannot be controlled by drainage or other procedures prior to study entry.
- Inability or unwillingness to take folic acid, vitamin B12 supplementation, or dexamethasone.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: Alimta
Treatment of Alimta
|
treatment of single pemetrexed with vitamin supplement until discontinued conditions are met
|
Aktiv komparator: IRESSA
Treatment of IRESSA
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treatment of Gefitinib will be applied until discontinued conditions are met
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Progressionsfri overlevelse (PFS)
Tidsramme: 2 år
|
2 år
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Response rate (RR)
Tidsramme: 2 years
|
2 years
|
Samlet overlevelse (OS)
Tidsramme: 2 år
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2 år
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. februar 2009
Primær færdiggørelse (Faktiske)
1. september 2012
Studieafslutning (Faktiske)
1. november 2012
Datoer for studieregistrering
Først indsendt
30. april 2009
Først indsendt, der opfyldte QC-kriterier
30. april 2009
Først opslået (Skøn)
1. maj 2009
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
10. december 2012
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
7. december 2012
Sidst verificeret
1. december 2012
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Luftvejssygdomme
- Neoplasmer
- Lungesygdomme
- Neoplasmer efter sted
- Neoplasmer i luftvejene
- Thoracale neoplasmer
- Karcinom, bronkogent
- Bronkiale neoplasmer
- Lungeneoplasmer
- Karcinom, ikke-småcellet lunge
- Molekylære mekanismer for farmakologisk virkning
- Nukleinsyresyntesehæmmere
- Enzymhæmmere
- Antineoplastiske midler
- Proteinkinasehæmmere
- Folinsyreantagonister
- Gefitinib
- Pemetrexed
Andre undersøgelses-id-numre
- C-TONG0806
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
produkt fremstillet i og eksporteret fra U.S.A.
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Ikke småcellet lungekræft
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AHS Cancer Control AlbertaCross Cancer InstituteAfsluttetOmfattende Stage Small Cel Lung CancerCanada
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Universitaire Ziekenhuizen KU LeuvenUkendtLymfom | Hodgkin lymfom | Non-Hodgkin lymfom (follikulært, diffust B-cel lymfom, PTLD og Mantle Cel lymfom)Belgien
Kliniske forsøg med Pemetrexed (Alimta)
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Asan Medical CenterEli Lilly and Company; Korean Cancer Study GroupUkendtIkke-småcellet lungekræftKorea, Republikken
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CanBas Co. Ltd.AfsluttetMetastatisk ikke-pladeepitel, ikke-småcellet lungekræftForenede Stater
-
Hellenic Oncology Research GroupUniversity Hospital of CreteAfsluttetIkke småcellet lungekræftGrækenland
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Northwestern UniversityNational Cancer Institute (NCI)UkendtLymfom | Tumorer i hjernen og centralnervesystemet | Metastatisk kræftForenede Stater
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Rongjie TaoNational Natural Science Foundation of ChinaUkendt
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Eli Lilly and CompanyAfsluttetIkke-småcellet lungekræft metastatisk | Ikke-skælcellet ikke-småcellet neoplasma i lungen | Ikke-småcellet lungekræft stadie IIIBDet Forenede Kongerige, Sverige
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PfizerAfsluttetKarcinom, ikke-småcellet lungeForenede Stater, Tyskland, Italien
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Southwest Oncology GroupNational Cancer Institute (NCI)AfsluttetLungekræftForenede Stater
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Norwegian University of Science and TechnologySt. Olavs HospitalAfsluttetKarcinom, ikke-småcellet lungeNorge
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Eli Lilly and CompanyAfsluttet