Status:
UNKNOWN
A Feasibility Study Of NAB-Paclitaxel In Combination With Carboplatin As First Line Treatment Of Gastrointestinal Neuroendocrine Carcinomas
Lead Sponsor:
Barwon Health
Collaborating Sponsors:
Specialised Therapeutics Australia
Deakin University
Conditions:
Gastrointestinal Neuroendocrine Carcinomas
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Gastrointestinal Neuroendocrine Tumours (NETs) are gaining increasing recognition as a highly prevalent disease, responsive to a number of therapies, some of which are proven in modern randomised cont...
Detailed Description
Gastrointestinal Neuroendocrine Tumours (NETs) are gaining increasing international recognition as a highly prevalent disease, responsive to a number of therapies, some of which are proven, but many o...
Eligibility Criteria
Inclusion
- Male or female with unresectable neuroendocrine carcinoma
- Age ≥18 yrs
- Histologically proven neuroendocrine carcinoma (NEC) as defined by the WHO Classification of Tumours of the Digestive System, 4th Ed - including tumours mixed with other malignancies (i.e. MANEC or mixed NEC/SCC). The features of small versus large cell NEC carcinoma will need to be documented.
- Tumour sufficiently Fluorodeoxyglucose (FDG)-avid (SUVmax minimum 3.5) on the initial staging PET
- Patients with advanced and/ or metastatic disease
- Measurable disease as assessed by CT scan of the chest, abdomen and pelvis as per RECIST v 1.1, within 21 days prior to commencement of study treatment
- ECOG performance status 0-1
- Adequate haematological, renal and hepatic function (neutrophils ≥2 × 109/L, platelets ≥100 × 109/L, hemoglobin ≥100g/L, total bilirubin ≤ 1.5 x upper limit of normal (ULN), aspartate aminotransferase and alanine aminotransferase ≤2.5 × ULN, alkaline phosphatases ≤2.5 ULN, creatinine ≤ 1.5 ULN)
- Signed, written informed consent
Exclusion
- NECs confirmed not to be from gastrointestinal primaries and NETs of lower grades (Ki67\<20)
- Suspected pulmonary origin of the NET e.g., FDG-PET avid lung lesions in patients with NEC liver metastases.
- Known hypersensitivity to NAB paclitaxel
- External beam radiotherapy to solitary target lesions. Patients who have received local radiotherapy of non-target lesions for local symptom control within the last 4 weeks must have recovered from any adverse effects of radiotherapy prior to starting treatment.
- Prior intrahepatic 90Ymicrospheres such as SIR-Spheres
- Major surgery/surgical therapy for any cause within 1 month or surgical therapy of loco-regional metastases within the last 3 months prior to starting treatment
- Severe cardiovascular, hepatic, neurologic or renal comorbid conditions
- Previous cytotoxic chemotherapy, or targeted therapy, or biotherapy for NEC (prior Somatostatin analogs (SSAs) are allowed)
- History of hepatitis B or C
- Sensory/motor neuropathy ≥ to grade 2, as defined by NCI CTCAE 4.0
- Pregnancy, lactation, or inadequate contraception. Women must be post-menopausal, infertile, or use a reliable means of contraception. Women of childbearing potential must have a negative pregnancy test done within 7 days prior to registration. Men must have been surgically sterilised or use a (double if required) barrier method of contraception
Key Trial Info
Start Date :
May 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2020
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT02215447
Start Date
May 1 2015
End Date
October 1 2020
Last Update
November 22 2017
Active Locations (3)
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1
Royal North Shore Hospital
St Leonards, New South Wales, Australia, 2065
2
Barwon Health
Geelong, Victoria, Australia, 3220
3
Royal Melbourne Hospital
Parkville, Victoria, Australia, 3050