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A Phase II study of a combination of eribulin and capecitabine in second line treatment after the failure of gemcitabine/abraxane first line in advanced pancreatic cancer

Studio Clinico

Patologia: Carcinoma del pancreas esocrino

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Monocentrico

Randomizzato: No

Fase di studio: II

Richiesta mandatoria di tessuto: No

Linee di trattamento: Seconda linea

Criteri di inclusione: 

1. Written informed consent (informed consent document to be approved by the Independent Ethics
2. Age ≥18 and < 75 years
3. Willing and able to comply with all aspects of the protocol
4. Histologically/cytologically confirmed metastatic or unresectable pancreatic cancer
5. Presence of at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (Recist version 1.1)
6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1 at study entry
7. Life expectancy of ≥3 months
8. Resistant/refractory to a first line chemotherapy including nab-paclitaxel/gemcitabine
9. Adequate haematological function (Absolute neutrophil count (ANC) ≥1.5 x 109/L; Platelet count ≥100 x 109/L; Haemoglobin ≥9 g/dL)
10. Adequate liver function (Total bilirubin ≤1.5 x upper limit of normal (ULN); AST, ALT ≤2.0 x ULN in patients without liver metastases; ≤5.0 x ULN in patients with liver metastases)
11. Adequate renal function (Serum creatinine ≤1.5 x ULN or calculated creatinine clearance ≥50 mL/min)
12. Women of childbearing potential must have a negative urine or serum beta h CG at Visit 1
(screening) and prior to starting study drugs on Day1. Female subjects of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for the duration of study participation and for 30 days (longer if appropriate) after the last dose of study drug. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately; the patient should be apprised of the potential hazard to the fetus and potential risk for loss of the pregnancy Perimenopausal women must be amenorrheic for at least 12 months to be considered of non childbearing potential. Male subjects who are not abstinent or have not undergone a successful vasectomy, who are partners of women of childbearing potential must use, or their partners must use, a highly effective methods of contraception (e.g. condom+spermicide, condom+diaphragm with spermicide, IUD) starting for at least one menstrual cycle prior to staring study drugs and throughout the entire study period and for 30 days (longer if appropriate)after the last dose of study drug. Those with partners using hormonal contraceptives must also be using an additional approved method of contraception.

Criteri di esclusione: 

1. Previous chemotherapy with capecitabine or 5-fluorouracil within 6 months of study entry
2. Evidence of clinically symptomatic CNS metastases
3. Treatment with any other investigational agent, or participation in another clinical trial within 28 days prior to enrolment
4. Suspected dihydropyrimidine dehydrogenase (DPD) deficiency
5. Undergone major surgery (e.g., intra-thoracic, intra-abdominal or intra-pelvic) ≤4 weeks prior to starting study drug or who have not recovered from side effects of such surgery
6. Palliative radiotherapy ≤4 weeks prior to starting study
7. Known allergy or hypersensitivity to eribulin mesylate or its excipients, or to fluoropyrimidine therapy
8. Evidence of any disease, neurological or metabolic dysfunction, physical examination finding or
laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use
of an investigational drug, or puts the patient at high risk for treatment-related complications
9. Congenital long QT syndrome
10. Pre-existing peripheral neuropathy NCI CTC-AE Grade >2 at enrolment
11. Moderate/severe hepatic impairment (Child-Pugh B/C)
12. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
13. Concurrent malignancy or malignancy within 3 years prior to study enrolment, with the exception of adequately treated basal cell carcinoma, squamous cell carcinoma or other non-melanomatous skin cancer, or in-situ carcinoma of the uterine cervix
14. Pregnancy or breastfeeding (breast feeding should be discontinued to be enrolled in the study)
15. Women of childbearing potential that refusal to adopt adequate contraceptive measures
16. Unwilling or unable to comply with the protocol
17. Subjects with known positive human immunodeficiency virus (HIV) status.
18. Subjects with current gastrointestinal disease or other condition resulting in an inability to take or absorb oral medications

 

Trattamento sperimentale: 

Eribulina mesilato+Capecitabina

Trattamento di controllo: 

Non applicabile

Centri partecipanti

Nord Italia

A.O.U. Policlinico di Modena
Via del Pozzo 71 - 41100 Modena - MO

Riferimento: Prof. Stefano Cascinu
Telefono: 0594225034
Email: stefano.cascinu@unimore.it

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2017-003621-15

Data di inserimento: 29.06.2018

Promotore

EISAI

CRO

Department of Oncology/Hematology; Azienda Ospedaliero-Universitaria, Università di Modena e Reggio, Modena

Principal Investigator ITALIA

Riferimento: Prof. Stefano Cascinu

Telefono: 0594225034

Email: stefano.cascinu@unimore.it

Localita: Modena

 

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