- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT01744340
A Dose Finding Study of Eribulin Mesylate and Cetuximab For Patients With Advanced Head and Neck and Colon Cancer
A Dose Finding Study of Eribulin Mesylate and Cetuximab For Patients With Advanced Head and Neck and Colon Cancer With an Expansion Cohort For Head and Neck Cancer: A Brown University Oncology Research Group Study
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Faza 2
- Faza 1
Kontakty i lokalizacje
Lokalizacje studiów
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New York
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Bronx, New York, Stany Zjednoczone, 10467
- Montefiore
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Rhode Island
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Pawtucket, Rhode Island, Stany Zjednoczone, 02860
- Memorial Hospital
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Providence, Rhode Island, Stany Zjednoczone, 02903
- Rhode Island Hospital
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Providence, Rhode Island, Stany Zjednoczone, 02904
- The Miriam Hospital
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria
- Histologically or cytologically confirmed advanced squamous cell cancer of the head and neck with progression after at least one prior therapy. (Chemoradiation is considered one line of therapy). Patients with unknown Head and Neck primaries are also eligible
- In the dose escalation cohorts, patients with advanced colon adenocarcinoma with wild-type kras who have previously received at least two lines of therapy for advanced disease are eligible- No longer applicable post February 2013 as all patients have been enrolled to the dose escalation phase
- In the expansion phase for patients with advanced colorectal cancer, only patients with mutated kras who have previously received at least two lines of therapy for metastatic disease will be eligible. Pathology report from diagnosis and report documenting KRAS status to be sent to BrUOG. No longer applicable as this phase of the study has been closed as of 5/6/2014 secondary to the lack of efficacy and activity of the single agent.
- Life expectancy of at least 3 months
- Patients must be aged 18 years or older
- Patients with measurable tumors according to RECIST .
- Patients must have an Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
- No severe concurrent illness that would interfere with protocol therapy.
- Patients must have adequate renal function as evidenced by ≤1.5 mg/dL or creatinine clearance > 40 mL/minute (min).
- Patients must have adequate bone marrow function as evidenced by absolute neutrophil count (ANC) > 1.5 x 109/L and platelet count > 100 x 109/L.
- Patients must have adequate hepatic function as evidenced by bilirubin ≤ 1.5 times the upper limit of normal (ULN) and alanine aminotransferase (ALT), and aspartate aminotransferase (AST) ≤ 3 x ULN (in the case of liver metastases ALT and AST ≤ 5 x ULN).
- Resolution of all chemotherapy or radiation-related toxicities to Grade 1 severity or below, except for alopecia.
- Patients must be willing and able to comply with the study protocol for the duration of the study.
- Patients must give written informed consent prior to any study-specific screening procedures with the understanding that the patient may withdraw consent at any time without prejudice.
- No other active invasive malignancy unless disease free for at least 2 years.
Exclusion Criteria
- For Head and Neck patients, no progression while receiving an EGFR inhibitor or within 6 months of stopping treatment with an EGFR inhibitor.
- Patients who received chemotherapy or investigational therapy within 3 weeks before treatment initiation. Radiation must be completed within 2 weeks before treatment initiation.
- Patients with a hypersensitivity to halichondrin B and/or halichondrin B chemical derivative.
- Patients who participated in a prior eribulin mesylate clinical trial, whether or not they received eribulin mesylate.
- Patients with other significant disease or disorders that, in the investigator's opinion, would exclude the patient from the study.
- Women who are pregnant or breast-feeding; women of childbearing potential with either a positive pregnancy test at screening or no pregnancy test; women of childbearing potential unless (1) surgically sterile or (2) using adequate measures of contraception in the opinion of the Investigator. Peri-menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential.
- Patients with brain or subdural metastases are not eligible, unless they have completed local therapy and have discontinued the use of corticosteroids for this indication for at least 4 weeks before starting treatment in this study. Any signs (e.g., radiologic) and/or symptoms of brain metastases must be stable for at least 4 weeks.
- Grade 2 or worse neuropathy.
- Significant cardiovascular impairment (history of congestive heart failure > NYHA G II, unstable angina or myocardial infarction within the past six months, or serious cardiac arrhythmia.
- QTc > 500 msec
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Nielosowe
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
---|---|
Eksperymentalny: head and neck
Cetuximab, 400 mg/m2 cycle 1 week 1, then 250 mg/m2/weekly there after Eribulin Mesylate 1.4mg/m2
|
Eribulin mesylate is administered by IV infusion over 2-5 minutes on day 1 and 8 of a 21 day cycle 1.4mg/m2 and Cetuximab 400 mg/m2 cycle 1 week 1, then 250 mg/m2/weekly thereafter Dose Level 1: 0.7 mg/m2 IV infusion days 1 and 8 of 21 day cycle Dose Level 2: 1.0 mg/m2 IV infusion days 1 and 8 of 21 day cycle Dose Level 3: 1.4 mg/m2 IV infusion days 1 and 8 of 21 day cycle |
Eksperymentalny: Colon- closed as of May 2014
Eribulin Mesylate: 1.4 mg/m2 IV infusion days 1 and 8 of 21 day cycle |
Eribulin Mesylate: 1.4 mg/m2 IV infusion days 1 and 8 of 21 day cycle |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
If Eribulin Mesylate, up to a Maximum Dose of 1.4 mg/m2 Day 1 and 8 of a 21 Day Cycle, Can be Safely Combined With Full Dose Cetuximab for Patients With Advanced Head and Neck Cancer and Colon Cancer.
Ramy czasowe: From Day 1 of Drug through end of cycle 2 equals (approximately) 42 days
|
A DLT was defined as:
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From Day 1 of Drug through end of cycle 2 equals (approximately) 42 days
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
Response Rate (Whether Patient's Disease is Progressing or Being Controlled) of Patients With Head and Neck Cancer Treated With Eribulin Mesylate and Cetuximab.
Ramy czasowe: From beginning of treatment to progression of disease, for an expected average of 1 year
|
This shows patients able to achieve Stable disease or better as their best response during course of study participation. Response will be evaluated by Revised Response Evaluation Criteria in Solid Tumors (RECIST) Guideline v1.1 RECIST Guideline version 1.1 Response Criteria Complete Response:Disappearance of all target lesions; Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters Progressive Disease:At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Stable Disease:Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study |
From beginning of treatment to progression of disease, for an expected average of 1 year
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Współpracownicy i badacze
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- BrUOG 254
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