- NABNEC
Trial Status
Completed
Cancer Type
NeuroEndocrine Tumours (NETs)
Protocol Title
A Randomised Phase II Study Of nab‐paclitaxel In Combination With Carboplatin As First Line Treatment Of Gastrointestinal Neuroendocrine Carcinomas
Purpose of the Study
The purpose of the NABNEC trial is to compare two different chemotherapy treatments (carboplatin plus nab-paclitaxel versus carboplatin plus etoposide) in improving disease response rates in patients. The study aims to identify which treatment is the most promising for further investigation.
The trial will also look at the survival outcomes and side effects of treatment. Blood, tissue and other biomarkers will be collected for translational research that will help increase our understanding of neuroendocrine carcinomas.
Eligibility Criteria
Inclusion Criteria
- Adults (18 years or over) with advanced and/or metastatic, unresectable neuroendocrine carcinoma
- Histologically proven (WHO/ ENET) Grade 3 NEC
- Normal bone marrow, liver and renal function
- Willing to follow all study requirements, including treatment, timing and/or nature of required assessments and follow-up
Exclusion Criteria
- Primary neuroendocrine cancer not gastro-intestinal in origin
- Suspected pulmonary origin of the neuroendocrine tumour
- Known hypersensitivity to nab-paclitaxel
- Severe existing cardiovascular, hepatic, neurologic or renal conditions
- Active infection of chronic active hepatitis B, C or HIV
CONTACT EMAIL
Study Chair
Professor Lorraine Chantrill
DETAILED INFORMATION AVAILABLE ON
Available online at the Australian New Zealand Clinical Trial Registry (ANZCTR) please click here.
FUNDING
National Health and Medical Research Council (NHMRC)
Trial Status
Completed
Cancer Type
NeuroEndocrine Tumours (NETs)
Protocol Title
“A Randomised Phase II Study Of nab‐paclitaxel In Combination With Carboplatin As First Line Treatment Of Gastrointestinal Neuroendocrine Carcinomas”
Aim
The aim of the NABNEC trial is to determine the safety and efficacy of carboplatin plus nab-paclitaxel in comparison with carboplatin plus etoposide for the treatment of grade 3, advanced gastrointestinal neuroendocrine carcinomas. In addition, the trial aims to explore translational biologic, molecular and functional imaging endpoints to inform future research and improve outcomes for NEC patients.
Background
Neuroendocrine carcinomas (NEC, WHO grade 3), comprising small cell NEC and large cell NEC, are aggressive rare cancers. They arise commonly in the gastrointestinal system. Currently available chemotherapy regimens for neuroendocrine cancers only have a short efficacy period. Grade 3 neuroendocrine tumours often relapse in a few months after treatment. For patients with advanced neuroendocrine cancers that cannot be removed by surgery, the cancer is incurable.
The current standard chemotherapy for neuroendocrine cancers (carboplatin plus etoposide) is commonly used for various cancer types in Australia. However, the effectiveness of this regimen for neuroendocrine cancers specifically is yet to be investigated in randomised trials.
The purpose of the NABNEC trial is to compare two different chemotherapy treatments (carboplatin plus nab-paclitaxel versus carboplatin plus etoposide) in improving disease response rates in patients. The study aims to identify which treatment is the most promising for further investigation.
The trial will also look at the survival outcomes and side effects of treatment. Blood, tissue and other biomarkers will be collected for translational research that will help increase our understanding of neuroendocrine carcinomas.
Clinical Trial Design
NABNEC is a randomised Phase II trial.
Participants of NABNEC will be randomised into two groups and receive different chemotherapy treatment plans. This can be carboplatin plus nab-paclitaxel or carboplatin plus etoposide.
Participants receiving chemotherapy with carboplatin plus nab-paclitaxel will be required to receive nab-paclitaxel intravenously once every week. Carboplatin will be administered once every three weeks.
Participants in the control group will receive intravenous etoposide for 3 days in a row, every 3 weeks. This will be in addition to carboplatin administered once every 3 weeks.
During the treatment period patients will be reviewed clinically before every cycle of chemotherapy. For both groups, the trial will continue until there is disease progression or until toxicity/side effects become unmanageable. All participants will be reviewed for side effects, outcomes of survival and cancer progression. Blood and tissue samples will also be taken, as well as specialised scans, to identify potential biomarkers of tumour cells.
Patients Recruited
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Contact Email
nabnec@ctc.usyd.edu.auPrincipal Investigator
Dr Lorraine Chantrill
More Information
Available online at the Australian New Zealand Clinical Trial Registry (ANZCTR) here.
Funding
National Health and Medical Research Council (NHMRC)
Changing outcomes for people with gastro-intestinal cancer since 1991