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- Klinische proef NCT00783471
Docetaxel Intermittent-Erlotinib (Tarceva®) In Metastatic Non Small Cell Lung Cancer (NSCLC) (DOPERLO)
15 juni 2010 bijgewerkt door: Hellenic Cooperative Oncology Group
Docetaxel Combined With Pulsatile Erlotinib (Tarceva®) In Patients With Metastatic Non Small Cell Lung Cancer (NSCLC) (DOPERLO)
To determine the more effective dosing sequence of intermittent erlotinib and docetaxel for treating patients with the diagnosis of advanced Non-Small-Lung-Cancer
Studie Overzicht
Toestand
Beëindigd
Interventie / Behandeling
Gedetailleerde beschrijving
The combination of chemotherapy [such as docetaxel] with continuous administration of targeted drugs which block the molecular machinery of cancer cell growth [such as erlotinib] have failed to improve their efficacy over only-chemotherapy in patients with metastatic lung cancer of the non-small cell histology type.
It is not yet known whether administering targeted drugs intermittently could result in improved efficacy of the combinations.
This is a multicenter randomized Phase II trial aiming to determine the more active dosing sequence between intermittent erlotinib and docetaxel for treating patients with advanced Non-Small-Lung-Cancer.Patients will be randomly assigned to one of two treatment arms: they will receive a 12-days course of erlotinib either before docetaxel [arm A] or after docetaxel administration [arm B].Treatment will be repeated every 21 days.Patients will be evaluated every 2 cycles (~6 weeks) for response using RECIST criteria.
Those patients achieving stable disease or better will continue therapy up to a total 8 cycles.
Those patients experiencing progressive disease will be taken off study.
Biopsy material will be assessed for biomarkers.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
51
Fase
- Fase 2
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Athens, Griekenland, 11526
- Sotiria Hospital
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Athens, Griekenland, 11528
- "Alexandra" Hospital
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Athens, Griekenland, 12461
- "Attikon" University Hospital, 2nd Dept. of Internal Medicine, Propaedeutic, Oncology Section
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Athens, Griekenland, 14564
- Agii Anargiri Cancer Hospital, 3rd Dept. of Medical Oncology
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Athens, Griekenland, 15123
- Hygeia Hospital
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Ioannina, Griekenland, 45500
- University General Hospital of Ioannina, Medical Oncology Dept
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Larissa, Griekenland, 41110
- Larissa University Hospital
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Piraeus, Griekenland, 18547
- Metropolitan Hospital, Second Dept of Medical Oncology
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Pireaus, Griekenland, 18547
- Metropolitan Hospital, 1st Dept. of Medical Oncology
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Rio, Patras, Griekenland, 26500
- Patras University Hospital, Dept. of Internal Medicine, Oncology Section
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Thessaloniki, Griekenland, 54007
- Theagenio Cancer Hospital, 2nd Dept of Medical Oncology
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Thessaloniki, Griekenland, 54007
- Theagenio Cancer Hospital, 3rd Dept. of Medical Oncology
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Thessaloniki, Griekenland, 56403
- "Papageorgiou" Hospital
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 75 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusion Criteria:
- Male and female patients aged 18 to 75 years inclusive, with histologically confirmed metastatic NSCLC will be enrolled.
- Patients must have not been previously treated with anticancer drugs for advanced disease.
- ECOG performance status of 0 - 1.
- Life expectancy of at least 12 weeks.
- Patients must be able to take oral medication.
- At least 4 weeks since any prior major surgery or extended-field radiotherapy. Patients who, in the opinion of the investigator, have fully recovered from limited surgery or have undergone limited-field radiotherapy within 2 weeks may also be considered eligible for the study
- Granulocyte count > 1,500/mm3 and platelet count > 100,000/mm3. Haemoglobin ³ 9.0g/dl.
- SGOT (AST) and SGPT (ALT) < 2,5 x ULN in the absence of liver metastases or up to 5 x ULN in case of liver metastases
- Alkaline phosphatase (ALP) < 2,5 x ULN. If alkaline phosphatase is > 2.5 x ULN, SGOT (AST) and SGPT (ALT) must be < 1.5 x ULN. If alkaline phosphatase is ³ 2.5 x ULN in the presence of liver metastases, SGOT and SGPT must be < 5 x ULN
- Serum creatinine <= 1.5 ULN or creatinine clearance > 60 ml/min.
- Normal serum calcium.
- For all females of childbearing potential a negative pregnancy test must be obtained within 48 hours before starting Tarceva/placebo treatment.
- Patients with reproductive potential must use effective contraception.
- Able to comply with study and follow-up procedures.
- Written (signed) Informed Consent to participate in the study.
- Written (signed) Informed Consent for use of tumour samples.
- Presence of measurable or evaluable disease (lesions that are present but do not fulfil the criteria for measurable disease).
- Formalin-fixed, paraffin-embedded tumour tissue samples representative of the tumour will be provided to sponsor within 3 weeks of the patient starting chemotherapy
Exclusion Criteria:
- Prior exposure to agents directed at the HER axis (e.g. gefitinib, cetuximab, trastuzumab).
- Prior chemotherapy or therapy with systemic anti-neoplastic therapy (e.g., monoclonal antibody therapy) for advanced disease. Prior surgery and/or localised irradiation is permitted.
- Patients who have undergone complete tumour resection after responding to platinum based chemotherapy.
- Any unstable systemic disease (including active infections, significant cardiovascular disease, [including myocardial infarction within the previous year], any significant hepatic, renal or metabolic disease) metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of study medication(s) or that might affect the interpretation of the results or render the patient at high risk from treatment complications.
- Any other malignancies within 5 years (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer).
- Patients are excluded if they have symptomatic brain metastasis or spinal cord compression that has not yet been definitively treated with surgery and/or radiation; patients with CNS metastases with evidence of stable disease (clinically stable imaging) and stable neurologic function are allowed to enter the study.
- Patients who are at risk (in the investigator's opinion) of transmitting human immunodeficiency virus (HIV) through blood or other body fluids are excluded.
- Any inflammatory changes of the surface of the eye.
- Patients who cannot take oral medication, who require intravenous alimentation, have had prior surgical procedures affecting absorption, or have active peptic ulcer disease.
- Nursing and/or pregnant women.
- Hypersensitivity to erlotinib (Tarceva) or to docetaxel or to any of the excipients.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Experimenteel: 1
Erlotinib followed by Docetaxel
|
Drug: Erlotinib 150 mg po daily, days 1-12 Drug: Docetaxel 75 mg/m2 IV over 30 min on day 15 Treatment will be repeated every 21 days
|
Experimenteel: 2
Docetaxel followed by Erlotinib
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Drug: Docetaxel 75 mg/m2 IV over 30 min on day 1 Drug: Erlotinib 150 mg po daily, days 4-15 Treatment will be repeated every 21 days
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
Progression free survival (PFS)
Tijdsspanne: Assessment every 6 weeks
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Assessment every 6 weeks
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
To compare the Overall Survival (OS),the Objective Response Rate (ORR) and duration of response
Tijdsspanne: Assessment every 6 weeks while on treatment and every 3 months post completion of 8 cycles of treatment until progression
|
Assessment every 6 weeks while on treatment and every 3 months post completion of 8 cycles of treatment until progression
|
Identify predictive signaling molecules of the EGFR pathway
Tijdsspanne: Assessment every 6 weeks while on treatment and every 3 months post completion of 8 cycles of treatment until progression
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Assessment every 6 weeks while on treatment and every 3 months post completion of 8 cycles of treatment until progression
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Onderzoekers
- Hoofdonderzoeker: Evangelos Briasoulis, MD, University of Ioannina Hospital, Medical School
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 november 2008
Primaire voltooiing (Werkelijk)
1 mei 2010
Studie voltooiing (Werkelijk)
1 juni 2010
Studieregistratiedata
Eerst ingediend
30 oktober 2008
Eerst ingediend dat voldeed aan de QC-criteria
30 oktober 2008
Eerst geplaatst (Schatting)
31 oktober 2008
Updates van studierecords
Laatste update geplaatst (Schatting)
16 juni 2010
Laatste update ingediend die voldeed aan QC-criteria
15 juni 2010
Laatst geverifieerd
1 juni 2010
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Ziekten van de luchtwegen
- Neoplasmata
- Longziekten
- Neoplasmata per site
- Neoplasmata van de luchtwegen
- Thoracale neoplasmata
- Carcinoom, bronchogeen
- Bronchiale neoplasmata
- Longneoplasmata
- Carcinoom, niet-kleincellige long
- Moleculaire mechanismen van farmacologische werking
- Enzymremmers
- Antineoplastische middelen
- Tubuline-modulatoren
- Antimitotische middelen
- Mitose modulatoren
- Proteïnekinaseremmers
- Docetaxel
- Erlotinibhydrochloride
Andere studie-ID-nummers
- HE 2D/07
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
product vervaardigd in en geëxporteerd uit de V.S.
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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