- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT00786110
Sorafenib Plus Paclitaxel in Adreno-Cortical-Cancer Patients (PAXO)
Sorafenib Plus Paclitaxel Metronomic Chemotherapy in Adreno-Cortical-Carcinoma Patients Progressing After 1st or 2nd Line Cytotoxic Chemotherapy
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
The study is designed as a Phase II, prospective, non randomized, open-label, single arm, multicenter trial, in which patients with locally advanced or metastatic ACC not amenable to complete surgical resection.
STUDY OBJECTIVES
The aim of this phase II trial is to evaluate the clinical benefit and toxicity of the combination of Sorafenib plus metronomic chemotherapy in patients with locally advanced or metastatic ACC who progressed after first or second line chemotherapy.
Primary objective
To assess the clinical benefit as measured by a non progressing rate after 4 months of the combination of Sorafenib plus weekly Paclitaxel in patients with locally advanced or metastatic ACC who progressed after first or second line chemotherapy.
Secondary objectives
- Assessment of Objective (Complete and Partial) Response Rates
- Assessment of Duration of Response
- Assessment of Hormonal Response
- Assessment of Progression-Free Survival
- Assessment of Overall Survival
- Assessment of the relationship between specific "biomarkers" and cancer- and treatment-related outcomes
- Assessment of Quality of Life by EORTC QLQ-C30
- Assessment of Toxicity
ENDPOINTS
The first disease assessment will be performed after 8-weeks, subsequent assessments will be performed every 12 weeks until end of the study.
Primary endpoint
- Progression-Free Survival rate ≥ 40% after 4 months
Secondary endpoints
- Response rate evaluation will be performed according to the RECIST criteria. The same methods of measurement and the same technique should be used to characterize each identified and reported lesion at baseline and during study.
TREATMENT SCHEME Treatment scheme consisted of oral Sorafenib 400 mg p.o. bid plus intravenous Paclitaxel 60 mg/mq/weekly i.v., until disease progression.
Studietype
Inschrijving (Verwacht)
Fase
- Fase 2
Contacten en locaties
Studiecontact
- Naam: Fulvia Daffara
- Telefoonnummer: Ext. 992 +390119026
- E-mail: fulviaclaudia@libero.it
Studie Contact Back-up
- Naam: Sperone Sperone
- Telefoonnummer: Ext. 017 +390119026
- E-mail: paola.sperone@email.it
Studie Locaties
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-
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Orbassano, Italië
- Werving
- Department of Clinical and Biological Sciences, University of Turin
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Hoofdonderzoeker:
- Alfredo Berruti
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Contact:
- Paola Perotti
- Telefoonnummer: Ext. 017 : +390119026
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Padova, Italië
- Nog niet aan het werven
- Azienda Ospedaliera di Padova
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Contact:
- Franco Mantero
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Onderonderzoeker:
- Franco Mantero
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Palermo, Italië
- Nog niet aan het werven
- Azienda Ospedaliera Università di Palermo
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Onderonderzoeker:
- Vittorio Gebbia
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Roma, Italië
- Nog niet aan het werven
- Policlinico Universitario Campus Biomedico- Roma
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Onderonderzoeker:
- Daniele Santini
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Rozzano, Italië
- Nog niet aan het werven
- Ist. Clin.Humanitas
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Contact:
- Carlo Carnaghi
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Onderonderzoeker:
- Carlo Carnaghi
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Histologically confirmed diagnosis of ACC
- Locally advanced or metastatic disease not amenable to radical surgery resection
- Radiologically monitorable disease
- Progressing disease after one or two cytotoxic chemotherapy regimens (including a platin-based protocol)
- ECOG performance status 0-2
- Life expectancy ≥ 3 months
- Subjects with at least one uni-dimensional(for RECIST) or bi-dimensional(for WHO) measurable lesion. Lesions must be measured by CT-scan or MRI
- Age ≥ 18 years
- Adequate bone marrow reserve (neutrophils ≥ 1500/mm³ and platelets ≥ 80.000/mm³)
- Hemoglobin > 9.0 g/dl
- Total bilirubin < 1.5 times the upper limit of normal
- PT-INR/PTT < 1.5 x upper limit of normal [Patients who are being therapeutically anticoagulated with an agent such as coumadin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists.]
- Serum creatinine < 1.5 x upper limit of normal
- Effective contraception in pre-menopausal female and male patients
- Patient´s written informed consent
- Ability to comply with the protocol procedures
Exclusion criteria:
- History of prior malignancy, except for cured non-melanoma skin cancer, cured in situ cervical carcinoma, or other treated malignancies with no evidence of disease for at least three years.
- History of HIV infection or chronic hepatitis B or C (This criteria should be modified to allow Hepatitis B or C in protocols looking at HCC patient population)
- Active clinically serious infections (> grade 2 NCI-CTC version 3.0)
- Symptomatic metastatic brain or meningeal tumors (unless the patient is > 6 months from definitive therapy, has a negative imaging study within 4 weeks of study entry and is clinically stable with respect to the tumor at the time of study entry)
- Patients with seizure disorder requiring medication (such as steroids or anti-epileptics)
- History of organ allograft The organ allograft may be allowed as protocol specific
- Severe renal (serum creatinine > 2.5 x ULN) or hepatic insufficiency (ALT / - AST > 2.5 x ULN or ALT/AST >5 x ULN if liver function abnormalities are due to the underlying malignancy and/or total serum bilirubin > 2.5 x ULN)
- Concomitant Rifampicin
- Concomitant St. John's Wort (Hypericum perforatum)
- Warfarin is allowed; however, close monitoring of Prothrombin Time (PT) is recommended
- Decompensated heart failure (ejection fraction <45%), myocardial infarction or revascularization procedure during the last 6 months, unstable angina pectoris, uncontrolled cardiac arrhythmia
- Hypertension that cannot be controlled by medications (>160/100 mmHg despite optimal medical therapy)
- Patients with recent or active bleeding diathesis
- Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment.
- Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial and three months after the completion of trial
- Previous treatment with Sorafenib or other anticancer chemotherapy or immunotherapy during the study or within 4 weeks of study entry
- Radiotherapy during study or within 3 weeks of start of study drug. (Palliative radiotherapy will be allowed).
- Major surgery within 4 weeks of start of study
- Autologous bone marrow transplant or stem cell rescue within 4 months of study
- Use of biologic response modifiers, such as G-CSF, within 3 week of study entry. [G-CSF and other hematopoietic growth factors may be used in the management of acute toxicity such as febrile neutropenia when clinically indicated or at the discretion of the investigator, however they may not be substituted for a required dose reduction.] [Patients taking chronic erythropoietin are permitted provided no dose adjustment is undertaken within 2 months prior to the study or during the study]
- Current treatment with another investigational drug
- Any other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, or which, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Experimenteel: 1 arm only
One arm only with Sorafenib plus Paclitaxel Patients enrolled will undergo strict follow-up Intervention: Sorafenib plus Paclitaxel |
Treatment scheme consisted of oral Sorafenib 400 mg p.o. bid until disease progression.
Intravenous Paclitaxel 60 mg/mq/weekly i.v., until disease progression.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
Disease free survival
Tijdsspanne: 4 months
|
4 months
|
Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
Overall survival
Tijdsspanne: 4 months
|
4 months
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Studie stoel: Alfredo Berruti MD, Internal Medicine, Department of Clinical and Biological Sciences, University of Turin, Italy
- Studie directeur: Eric Baudin, Oncologie Endocrinienne et Médecine Nucléaire, Institut Gustave Roussy, Villejuif, France.
- Hoofdonderzoeker: Massimo Terzolo, MD, Internal Medicine, Department of Clinical and Biological Sciences, University of Turin, Italy
- Studie directeur: Sophie Leboulleux, Service de Médecine Nucléaire et de Cancérologie Endocrinienne, Institut Gustave-
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Neoplasmata per histologisch type
- Neoplasmata
- Neoplasmata per site
- Adenocarcinoom
- Neoplasmata, glandulair en epitheel
- Endocriene systeemziekten
- Endocriene klierneoplasmata
- Bijnierziekten
- Bijnierschors neoplasmata
- Bijnierneoplasmata
- Bijnierschorsziekten
- Carcinoom
- Bijnierschorscarcinoom
- Moleculaire mechanismen van farmacologische werking
- Enzymremmers
- Antineoplastische middelen
- Tubuline-modulatoren
- Antimitotische middelen
- Mitose modulatoren
- Antineoplastische middelen, fytogeen
- Proteïnekinaseremmers
- Paclitaxel
- Sorafenib
Andere studie-ID-nummers
- EudraCT 2008-000759-91
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 .
Klinische onderzoeken op Bijnierschorscarcinoom
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Hospices Civils de LyonWervingKwaadaardige tumoren als Chordoma, Adenoid Cystic Carcinoma en SarcoomFrankrijk
-
CG Oncology, Inc.BeëindigdCarcinoom in Situ | Overgangscelcarcinoom | Blaaskanker | Carcinoma in situ gelijktijdig met papillaire tumorenVerenigde Staten
Klinische onderzoeken op Sorafenib
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Ohio State University Comprehensive Cancer CenterBayerBeëindigd
-
Technical University of MunichVoltooid
-
Ottawa Hospital Research InstituteBayerVoltooidGemetastaseerde colorectale kankerCanada
-
BayerAmgenVoltooidCarcinoomVerenigde Staten
-
British Columbia Cancer AgencyIngetrokkenLokaal geavanceerde plaveiselcelcarcinomen van het hoofd en de nek (SCCHN)Canada
-
Yiviva Inc.WervingGeavanceerd hepatocellulair carcinoomVerenigde Staten, Taiwan, China, Hongkong
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Cancer Institute and Hospital, Chinese Academy...VoltooidHepatocellulair carcinoom, radiotherapie, sorafenibChina
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New Mexico Cancer Care AllianceBeëindigdGemetastaseerd niercelcarcinoomVerenigde Staten
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BayerVoltooidHepatocellulair carcinoomTaiwan
-
National Cancer Institute (NCI)Actief, niet wervendGastro-intestinale stromale tumorVerenigde Staten