- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01426074
DCE-MRI PET Bevacizumab Study in Rectal Cancer
20 agosto 2018 aggiornato da: Abramson Cancer Center of the University of Pennsylvania
A Phase II/Pharmacodynamic Study of Preoperative or Definitive FOLFOX Plus Bevacizumab, With the Additional Pharmacodynamic Goal of Assessing Tumor Blood Flow as Measured by Dynamic Contrast-enhanced MRI, and the Induction of Hypoxia and Apoptosis as Measured by PET in Patients With Rectal Cancer
This study will determine the following: the response rate (including pathological CR rate), TTP, and complications of treatment in patients with rectal cancer treated with FOLFOX bevacizumab, the alteration of tumor blood flow (assessed by DCE-MRI as percentage change in Ktrans) after 1 cycle of bevacizumab therapy compared to baseline value in patients treated with FOLFOX alone and those treated with bevacizumab at 5 mg/kg., the degree of hypoxis (measured by tumor uptake of the 2-nitroimidazole EF5) induced by bevacizumab treatment and its relationship to changes in tumor blood flow, and the degree of apoptosis (measured by tumor uptake of di-annexin V) induced by bevacizumab treatment and its relationship to changes in tumor blood flow.
Panoramica dello studio
Stato
Ritirato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
The primary objectives of this study will determine the following: the response rate (including pathological CR rate), TTP, and complications of treatment in patients with rectal cancer treated with FOLFOX bevacizumab, the alteration of tumor blood flow (assessed by DCE-MRI as percentage change in Ktrans) after 1 cycle of bevacizumab therapy compared to baseline value in patients treated with FOLFOX alone and those treated with bevacizumab at 5 mg/kg., the degree of hypoxis (measured by tumor uptake of the 2-nitroimidazole EF5) induced by bevacizumab treatment and its relationship to changes in tumor blood flow, and the degree of apoptosis (measured by tumor uptake of di-annexin V) induced by bevacizumab treatment and its relationship to changes in tumor blood flow.
The secondary objectives of this study is to determine in an exploratory fashion the relationship between tumor blood flow, hypoxia induction, and apoptosis induction , and time to progression in patients continuing on to receive Bevacizumab 5 mg/kg, to analyze archival tumor from the patients treated in this trial for mutations in the MKK7 and SEK1 genes, and by semi-quantitative IHC for these and other relevant proteins, to determine the relationship between vascular proliferation as measured by DCE-MRI and markers of endothelial cell proliferation, and to obtain pilot data on whether assays that measure vascular endothelial cell mitogenic stimulation and mitogenic activity may predict response to therapy, time to progression and overall survival in patients receiving bevacizumab 5 mg/kg.
Tipo di studio
Interventistico
Fase
- Fase 2
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
Inclusion Criteria:
- Patients must have histologically documented advanced or metastatic adenocarcinoma of the rectum, T3 or T4, N any, M0 or M1. Patients must have available and identified tissue for immunohistochemical analysis and agree to submit it for the correlative endpoints. When available, formalin-fixed,paraffin-embedded tissue from previous biopsy or surgical resection will suffice.
- Patients must measurable disease as defined by the RECIST criteria as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 20mm with conventional techniques on either CT, MRI, or EUS. marker (CEA) elevation alone is in sufficient for entry.
- Patients may have had prior adjuvant treatment of rectal cancer. The prior treatment regimen must not have included bevacizumab but may have included oxaliplatin and the last dose of chemotherapy must have been > 6 months prior to study entry. Patients with prior radiotherapy are acceptable. It must be at least 2 weeks since administration of radiation therapy and all signs of toxicity must have abated.
- Patients with prior malignancies other than colorectal cancer are allowed, provided they have been treated with curative, intent, and have no evidence of recurrence of that malignancy.
- Patients must be age 18 years or older.
- Patients must have an ECOG performance status of 0-1.
- The following required required Initial Laboratory Values should be obtained within 4 weeks of the start of treatment:
Granulocytes ≥ 1,500/ml Platelet Count ≥ 100,000/ml Creatinine ≤ 1.5 x upper limit of normal Bilirubin ≤ 1.5 x upper limit of normal AST ≤ 5 x upper limit of normal Urine: Urine protein: creatinine ration ≤ 1.0 at screening
- Patients must not be pregnant or lactating as chemotherapy is though to present substantial risk to the fetus/infant
- Patients must have a life expectancy of greater than three months.
- Patients must have the ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
- Patients may not be receiving any other investigational agents.
- Patients with the following contraindication to MRI are excluded: Hypersensitivity to gadolinium Contraindicated metallic device, including pacemaker, non-MRI compatible aneurysm clip, other non-MRI compatible mechanical and/or electrical device, or metallic fragments.
- Patients with severe claustrophobia
- Patients with a history of allergic reactions attributed to Flagyl (metronidazole) which has a chemical structure similar to EF5 are excluded.
- Patients with T1 or T2 N0M0 disease are not eligible.
- Major surgical procedure, open biopsy or significant traumatic injury within 28 days to Day 0, anticipation of need for major surgical procedure during the course of the study. Minor surgical procedures such as port placement, fine needle aspirations or core biopsies within 3 days prior to Day 0.
- Patients with serious nonhealing wounds, ulcers, or bone fractures.
- Patients with a history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 0.
- Patients with a history of myocardial infarction, unstable angina, or cerebrovascular accident < 6 months prior to registration.
- Patients with clinically significant peripheral vascular disease.
- Patients with New York Heart Association Class II or greater congestive heart failure (Class II is defined as symptoms of fatigue, dyspnea or other symptoms with ordinary physical activity) See Appendix E.
- Patients using oral or parenteral anticoagulation are not excluded provided they are on a stable dose of anticoagulant.
- patients with pre-existing hypertension should be on a stable antihypertensive regimen and have a blood pressure ≤ 150/100 mmHg at the time of enrollment.
- Patients must not have known brain metastases because the study drug has not been adequately tested in this setting.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
---|
Pathologic Complete Response (pCR)
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 agosto 2011
Completamento primario (Effettivo)
11 giugno 2014
Completamento dello studio (Effettivo)
11 giugno 2014
Date di iscrizione allo studio
Primo inviato
29 agosto 2011
Primo inviato che soddisfa i criteri di controllo qualità
30 agosto 2011
Primo Inserito (Stima)
31 agosto 2011
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
21 agosto 2018
Ultimo aggiornamento inviato che soddisfa i criteri QC
20 agosto 2018
Ultimo verificato
1 agosto 2018
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Malattie dell'apparato digerente
- Neoplasie
- Neoplasie per sede
- Neoplasie gastrointestinali
- Neoplasie dell'apparato digerente
- Malattie gastrointestinali
- Malattie intestinali
- Neoplasie intestinali
- Malattie del retto
- Neoplasie colorettali
- Neoplasie Rettali
- Effetti fisiologici delle droghe
- Agenti antineoplastici
- Agenti antineoplastici, immunologici
- Inibitori dell'angiogenesi
- Agenti di modulazione dell'angiogenesi
- Sostanze per la crescita
- Inibitori della crescita
- Bevacizumab
Altri numeri di identificazione dello studio
- UPCC 05209
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Pazienti con cancro del retto
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletatoAdenocarcinoma dell'intestino tenue | Adenocarcinoma dell'intestino tenue in stadio III AJCC v8 | Adenocarcinoma dell'intestino tenue in stadio IIIA AJCC v8 | Adenocarcinoma dell'intestino tenue in stadio IIIB AJCC v8 | Adenocarcinoma dell'intestino tenue stadio IV AJCC v8 | Ampolla di Vater... e altre condizioniStati Uniti
-
Georgetown UniversityNational Cancer Institute (NCI); American Cancer Society, Inc.; Susan G. Komen...CompletatoStudio delle donne cinesi che non hanno aderito alle linee guida per lo screening mammografico dell'American Cancer SocietyStati Uniti
-
National Cancer Institute (NCI)ReclutamentoKita-kyushu Lung Cancer Antigen 1, umanoStati Uniti
-
Novartis PharmaceuticalsReclutamentoEGFR mutante avanzato Non SmallSellLung Cancer (NSCLC), KRAS G12-mutant NSCLC, Esophageal SquamousCell Cancer (SCC), Head/Neck SCC, MelanomaOlanda, Corea, Repubblica di, Spagna, Taiwan, Giappone, Italia, Canada, Stati Uniti, Singapore
-
Emory UniversityNational Cancer Institute (NCI)RitiratoCancro al seno in stadio IV prognostico AJCC v8 | Neoplasia maligna metastatica nel cervello | Carcinoma mammario metastatico | Anatomic Stage IV Breast Cancer American Joint Committee on Cancer (AJCC) v8
-
NRG OncologyNational Cancer Institute (NCI)Attivo, non reclutanteCancro al seno in stadio anatomico IV AJCC v8 | Cancro al seno in stadio IV prognostico AJCC v8 | Neoplasia maligna metastatica nell'osso | Neoplasia maligna metastatica nei linfonodi | Neoplasia maligna metastatica nel fegato | Carcinoma mammario metastatico | Neoplasia maligna metastatica nel... e altre condizioniStati Uniti, Canada, Arabia Saudita, Corea, Repubblica di
-
Jonsson Comprehensive Cancer CenterNon ancora reclutamentoCarcinoma della prostata | Stadio IVB Cancro alla prostata American Joint Committee on Cancer (AJCC) v8Stati Uniti
-
Rashmi Verma, MDNational Cancer Institute (NCI)ReclutamentoCarcinoma prostatico resistente alla castrazione | Adenocarcinoma prostatico metastatico | Stadio IVB Cancro alla prostata American Joint Committee on Cancer (AJCC) v8Stati Uniti
-
Assiut UniversityNon ancora reclutamentoDeterminare l’incidenza cumulativa di AKI utilizzando i criteri KDIGO in pazienti pediatrici con tumori maligni presso il South Egypt Cancer Institute (SECI)
-
Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI)Attivo, non reclutanteStadio III Adenocarcinoma della prostata AJCC v7 | Stadio II Adenocarcinoma prostatico AJCC v7 | Fase I Adenocarcinoma della prostata American Joint Committee on Cancer (AJCC) v7Stati Uniti
Prove cliniche su Bevacizumab 5 mg/kg
-
Hoffmann-La RocheCompletatoCancro colorettaleFrancia, Israele, Italia, Spagna, Svezia, Hong Kong, Australia, Canada, Svizzera, Stati Uniti, Irlanda, Danimarca, Germania, Taiwan, Federazione Russa, Cina, Nuova Zelanda, Austria, Regno Unito, Ungheria, Tailandia, Sud Africa, Messi... e altro ancora
-
RezoluteReclutamentoIperinsulinismo congenitoBulgaria, Canada, Danimarca, Francia, Georgia, Germania, Grecia, Israele, Oman, Qatar, Arabia Saudita, Spagna, Tacchino, Emirati Arabi Uniti, Regno Unito, Vietnam
-
aTyr Pharma, Inc.Kyorin Pharmaceutical Co.,LtdReclutamentoSarcoidosi polmonareStati Uniti, Giappone, Olanda, Spagna, Regno Unito, Francia, Italia, Brasile, Germania, Porto Rico
-
Crucell Holland BVNational Institute of Allergy and Infectious Diseases (NIAID)CompletatoInfluenzaStati Uniti
-
Bill & Melinda Gates Medical Research InstituteReclutamento
-
Merck Sharp & Dohme LLCTerminato
-
Janssen Research & Development, LLCJanssen Biologics BVCompletatoColite ulcerosaStati Uniti, Francia, Regno Unito, Belgio, Svizzera, Israele, Canada, Australia, Olanda, Nuova Zelanda, Austria, Germania, Danimarca, Cechia, Argentina
-
NeuroVive Pharmaceutical ABCompletatoTrauma cranicoDanimarca
-
Shanghai Zhongshan HospitalNon ancora reclutamento
-
Naurex, Inc, an affiliate of Allergan plcCompletatoDisturbo depressivo maggioreStati Uniti