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- Klinische proef NCT01226719
FOLFOXIRI Plus Panitumumab Patients With Metastatic KRAS Wild-Type Colorectal Cancer With Liver Metastases Only
A Phase II Study of FOLFOXIRI Plus Panitumumab Followed by Evaluation for Resection, in Patients With Metastatic KRAS Wild-Type Colorectal Cancer With Liver Metastases Only
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 2
Contacten en locaties
Studie Locaties
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Arkansas
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Jonesboro, Arkansas, Verenigde Staten, 72401
- NEA Baptist Clinic
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Florida
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Ft. Myers, Florida, Verenigde Staten, 33916
- Florida Cancer Specialists
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Orlando, Florida, Verenigde Staten, 32804
- Florida Hospital Cancer Institute
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St. Petersburg, Florida, Verenigde Staten, 33705
- Florida Cancer Specialists
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Georgia
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Gainesville, Georgia, Verenigde Staten, 30501
- Northeast Georgia Medical Center
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Indiana
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Terre Haute, Indiana, Verenigde Staten, 47802
- Providence Medical Group
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Terre Haute, Indiana, Verenigde Staten, 47802
- Hope Cancer Center
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Maryland
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Bethesda, Maryland, Verenigde Staten, 20817
- Center for Cancer and Blood Disorders
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New Hampshire
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Portsmouth, New Hampshire, Verenigde Staten, 03801
- Portsmouth Regional Hospital
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New Jersey
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Morristown, New Jersey, Verenigde Staten, 07960
- Hematology-Oncology Associates of Northern NJ
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Ohio
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Cincinnati, Ohio, Verenigde Staten, 45242
- Oncology Hematology Care, Inc
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Tennessee
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Chattanooga, Tennessee, Verenigde Staten, 37404
- Chattanooga Oncology Hematology Associates
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Collierville, Tennessee, Verenigde Staten, 38017
- Family Cancer Center
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Nashville, Tennessee, Verenigde Staten, 37203
- Tennessee Oncology, PLLC
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Texas
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Fort Worth, Texas, Verenigde Staten, 76104
- The Center for Cancer and Blood Disorders
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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:
- Patient must have a biopsy confirmed adenocarcinoma of the colon or rectum with stage IV (metastatic) liver-only disease, as defined by staging with CT scans.
- Patients must have a baseline evaluation to determine whether liver metastases are resectable (e.g. a single liver metastasis in a resectable location)or unresectable (surgical consultation is recommended). Both groups are eligible for this study.
- Tumor tissue must reveal wild-type KRAS expression (i.e. no KRAS mutation) prior to study entry (see Section 7.4.4.).
- Patients must have at least one unidimensional measurable lesion definable by CT scan. Disease must be measurable per RECIST version 1.1 criteria (see Section 9).
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 (see Appendix A).
Laboratory values as follows:
ANC greater than 1500/μL
Hgb greater than9 g/dL
Platelets greater than 100,000/μL
AST/SGOT less than 5.0 x ULN
ALT/SGPT less than or equal to 5.0 x ULN
Alk Phos less than or equal to 5.0 x ULN
Bilirubin less than or equal to 1.5 x ULN
Creatinine 1.5 mg/dL or calculated creatinine clearance 50 ml/min
Magnesium LLN
- Patient must have a life expectancy of greater than 12 weeks.
- Patient must be greater than or equal to 18 years of age.
- Patient must be accessible for treatment and follow-up.
- Women of childbearing potential must have a negative serum or urine pregnancy test performed less than or equal to 7 days prior to start of treatment. Women of childbearing potential or men with partners of childbearing potential must use effective birth control measures during treatment and during the 6 months following completion of study treatment. If a woman becomes pregnant or suspects she is pregnant while participating in this study, she must agree to inform her treating physician immediately.
- Patient must be able to understand the nature of the study and give written informed consent prior to study entry.
Exclusion Criteria:
- Prior systemic therapy for metastatic colorectal cancer (including chemotherapy, bevacizumab, cetuximab, panitumumab, and other targeted agents).
- Adjuvant chemotherapy (and/or chemoradiation) for colorectal carcinoma ending less than or equal to 12 months prior to the diagnosis of metastatic cancer. Prior radiation therapy (in the metastatic setting) may be allowed if it was completed greater than or equal to 4 weeks prior to enrollment and measurable lesions are outside the radiation portal site.
- Any detectable metastases in areas other than the liver.
- Known liver disease or other significant medical illness that would exclude the patient as a candidate for resection of liver metastases.
- Patients requiring therapeutic coumadin or heparin (for a history of pulmonary emboli or deep vein thrombosis [DVT]) will be excluded.
- Patients who have had a major surgical procedure (not including mediastinoscopy), open biopsy, or significant traumatic injury less than or equal to 4 weeks prior to beginning treatment.
- History of Gilbert's disease.
- History of hypersensitivity to active or inactive excipients of any component of treatment (5 fluorouracil, irinotecan, panitumumab, and/or oxaliplatin), or known dipyrimidine dehydrogenase (DPD) deficiency
- Serious cardiac arrhythmia requiring medication.
- Concurrent severe, intercurrent illness including, but not limited to, ongoing or active infection, an infection requiring IV antibiotics, or psychiatric illness/social situations that would limit compliance with study requirements.
- Patient with known diagnosis of human immunodeficiency virus (HIV), hepatitis C virus or acute or chronic hepatitis B infection.
- Mental condition that would prevent patient comprehension of the nature of, and risk associated with, the study.
- Use of any non-approved or investigational agent less than or equal to 28 days prior to administration of the first dose of study drug.
- Past or current history of neoplasm other than the entry diagnosis with the exception of treated non melanoma skin cancer or carcinoma in situ of the cervix, or other cancers cured by local therapy alone and a DFS greater than or equal to 5 years.
- Patients with National Cancer Institute Common Terminology Criteria for Adverse Events v4.0 (NCI CTCAE) Grade 2 peripheral neuropathy.
- Female patients who are pregnant or lactating.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: FOLFOXIRI+panitumumab regimen
All patients will receive the FOLFOXIRI/panitumumab regimen, with drugs administered in the following order:
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6 mg/kg, 60-90 minute IV infusion every 2 weeks
Andere namen:
85 mg/m2, 2-hour IV infusion every 2 weeks
Andere namen:
125 mg/m2, 1-hour IV infusion every 2 weeks
Andere namen:
200 mg/m2, 2-hour IV infusion every 2 weeks
Andere namen:
3200 mg/m2 IV, 48-hour continuous infusion every two weeks
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Overall Response Rate (ORR)
Tijdsspanne: 18 months
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The Percentage of Patients Who Experience an Objective Benefit From Treatment.
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
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18 months
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Algehele overleving (OS)
Tijdsspanne: 18 maanden
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De tijdsduur, in maanden, dat patiënten in leven waren vanaf hun eerste datum van protocolbehandeling tot aan hun overlijden
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18 maanden
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Progression-free Survival (PFS)
Tijdsspanne: 18 months
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The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease.
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
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18 months
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R0 Resection Rate
Tijdsspanne: 18 months
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To determine the rate of complete (R0) resection for patients treated with this regimen.
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18 months
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To Determine the Acute Toxicity Produced by This Regimen.
Tijdsspanne: 18 months
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The analyses of safety will be based on the frequency of adverse events and their severity for patients who received at least one dose of study treatment.
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18 months
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Medewerkers en onderzoekers
Medewerkers
Onderzoekers
- Studie stoel: Johanna Bendell, MD, SCRI Development Innovations, LLC
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
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
- Ziekten van het spijsverteringsstelsel
- Neoplasmata
- Neoplasmata per site
- Gastro-intestinale neoplasmata
- Neoplasmata van het spijsverteringsstelsel
- Gastro-intestinale aandoeningen
- Colon Ziekten
- Darmziekten
- Intestinale neoplasmata
- Rectale ziekten
- Colorectale neoplasmata
- Fysiologische effecten van medicijnen
- Moleculaire mechanismen van farmacologische werking
- Enzymremmers
- Antimetabolieten, antineoplastische
- Antimetabolieten
- Antineoplastische middelen
- Immunosuppressieve middelen
- Immunologische factoren
- Beschermende middelen
- Topoisomeraseremmers
- Antineoplastische middelen, immunologisch
- Micronutriënten
- Vitaminen
- Topoisomerase I-remmers
- Tegengif
- Vitamine B-complex
- Fluoruracil
- Oxaliplatine
- Leucovorin
- Irinotecan
- Panitumumab
Andere studie-ID-nummers
- SCRI GI 134
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 Colorectale kanker
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)VoltooidAdenocarcinoom van de dunne darm | Stadium III Adenocarcinoom van de dunne darm AJCC v8 | Stadium IIIA Adenocarcinoom van de dunne darm AJCC v8 | Stadium IIIB dunne darm adenocarcinoom AJCC v8 | Stadium IV Adenocarcinoom van de dunne darm AJCC v8 | Ampulla van Vater Adenocarcinoom | Stadium III... en andere voorwaardenVerenigde Staten
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University of UtahNational Cancer Institute (NCI)WervingVermoeidheid | Sedentaire levensstijl | Gemetastaseerd prostaatcarcinoom | Stadium IV prostaatkanker AJCC (American Joint Committee on Cancer) v8 | Stadium IVA prostaatkanker AJCC (American Joint Committee on Cancer) v8 | Stadium IVB prostaatkanker AJCC (American Joint Committee on Cancer) v8Verenigde Staten
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Georgetown UniversityNational Cancer Institute (NCI); American Cancer Society, Inc.; Susan G. Komen...VoltooidBestudeer Chinese vrouwen die zich niet hebben gehouden aan de richtlijnen voor screening op mammografie van de American Cancer SocietyVerenigde Staten
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BioNTech SESeventh Framework ProgrammeVoltooidBorstkanker (Triple Negative Breast Cancer (TNBC))Zweden, Duitsland
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Novartis PharmaceuticalsVoltooidGeavanceerde Triple Negative Breast Cancer (TNBC) met hoge TAM'sFrankrijk, Italië, Oostenrijk, Taiwan, Verenigde Staten, Spanje, Australië, Korea, republiek van, België, Duitsland, Hongkong, Kalkoen
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Rashmi Verma, MDNational Cancer Institute (NCI)WervingCastratieresistent prostaatcarcinoom | Gemetastaseerd prostaatadenocarcinoom | Stadium IVB Prostaatkanker American Joint Committee on Cancer (AJCC) v8Verenigde Staten
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Jonsson Comprehensive Cancer CenterNog niet aan het wervenProstaatcarcinoom | Stadium IVB Prostaatkanker American Joint Committee on Cancer (AJCC) v8Verenigde Staten
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Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI); National Institutes of Health (NIH)WervingAnatomische fase II borstkanker AJCC v8 | Anatomische fase III borstkanker AJCC v8 | Borstcarcinoom in een vroeg stadium | Anatomische fase I Borstkanker American Joint Committee on Cancer (AJCC) v8Verenigde Staten
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University of Southern CaliforniaNational Cancer Institute (NCI)WervingLokaal gevorderd pancreasadenocarcinoom | Inoperabel pancreasadenocarcinoom | Fase III Pancreaskanker American Joint Committee on Cancer v8Verenigde Staten
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Jonsson Comprehensive Cancer CenterIngetrokkenProstaat Adenocarcinoom | Prostaatkanker stadium II AJCC v8 | Stadium IIC prostaatkanker AJCC v8 | Stadium IIA prostaatkanker AJCC v8 | Stadium IIB prostaatkanker AJCC v8 | Fase I Prostaatkanker American Joint Committee on Cancer (AJCC) v8Verenigde Staten
Klinische onderzoeken op Panitumumab
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University of Alabama at BirminghamWerving
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Spanish Cooperative Group for the Treatment of...AmgenVoltooid
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TakedaVoltooid
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WiSP Wissenschaftlicher Service Pharma GmbHGesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbHBeëindigdUrineblaaskankerDuitsland
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Cliniques universitaires Saint-Luc- Université...Beëindigd
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Gruppo Oncologico del Nord-OvestVoltooidGemetastaseerde colorectale kankerItalië
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Jonsson Comprehensive Cancer CenterVoltooidProstaatkankerVerenigde Staten
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University of UtahBeëindigdKRAS en NRAS Wildtype colorectale kankerVerenigde Staten
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