NABNEC

The aim of NABNEC is to determine the safety and efficacy of carboplatin plus nab-paclitaxel in comparison with the current standard chemotherapy treatment plan (carboplatin plus etoposide) for advanced gastrointestinal neuroendocrine carcinomas (NECs).

Neuroendocrine cancers are rare cancers that develop in the neuroendocrine cells – a network of glands and nerve cells that produce and release hormones into the bloodstream to control normal body functions. Neuroendocrine cells can be found in most organs and therefore, neuroendocrine cancers can be found in different locations in the body – most commonly in the gastrointestinal tract.  The aim of the study is to find which treatment is most promising – a combination of carboplatin and etoposide chemotherapy, or carboplatin and paclitaxel chemotherapy – in improving outcomes for patients with advanced gastrointestinal neuroendocrine carcinoma.

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Trial Status

Open

Cancer Type

NeuroEndocrine Tumours (NETs)

If you think this trial is relevant to your situation, please contact your Cancer Specialist to discuss further.

Aim

The aim of the study is to determine the safety and efficacy of carboplatin plus nab-paclitaxel in comparison with the current standard chemotherapy treatment plan (carboplatin plus etoposide) and find the most promising treatment for advanced gastrointestinal neuroendocrine carcinomas (NECs).

Summary

Neuroendocrine cancers are rare cancers that develop in the neuroendocrine cells – a network of glands and nerve cells that produce and release hormones into the bloodstream to control normal body functions. Neuroendocrine cells can be found in most organs and therefore, neuroendocrine cancers can be found in different locations in the body – most commonly in the gastrointestinal tract.

Neuroendocrine tumours are graded from 1 to 3 depending on how they look under a microscope, with grade 3 being the most aggressive. NECs that have spread around the body (metastasised) or cannot be removed by surgery are incurable with currently available treatments.

In Australia, the current standard chemotherapy treatment plan for neuroendocrine cancers is carboplatin plus etoposide, which is commonly used to treat various cancers. However, the effectiveness of the treatment plan for neuroendocrine cancers is yet to be investigated in randomised trials. Also, although initial chemotherapy may seem effective, the cancer often returns in the patient within months, so better treatments are needed

The aim of the study is to find which treatment is most promising – a combination of carboplatin and etoposide chemotherapy, or carboplatin and paclitaxel chemotherapy – in improving outcomes for patients with advanced gastrointestinal neuroendocrine carcinoma.

Finding the treatment that is most promising would indicate that it is suitable for further investigation to guide best practice. The trial will look at the outcomes of survival, monitor the side effects of treatment and provide useful information and increase our understanding of the biology of neuroendocrine carcinomas.

Participating Centres

New South Wales
Northern Cancer Institute
Royal North Shore Hospital
Westmead Hospital
St Vincents Public Hospital
St George Hospital
Calvary Mater- Newcastle
Border Medical Oncology
Queensland
Townsville Hospital
South Australia
Flinders Medical Centre
Tasmania
Royal Hobart Hospital
Victoria
Peter MacCallum Cancer Centre
The University Hospital, Geelong
Monash Medical Centre
Western Australia
St John of God Hospital, Subiaco
Fiona Stanley Hospital

Trial Status

Open

Cancer Type

NeuroEndocrine Tumours (NETs)

If you think this clinical trial may be relevant to your patient or to discuss further, please contact the Clinical Trial team.

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

Click to access the table and view recruitment data on all AGITG open trials:

Open Trial Recruitment Table

Participating Centres

New South Wales
Northern Cancer Institute
Royal North Shore Hospital
Westmead Hospital
St Vincents Public Hospital
St George Hospital
Calvary Mater- Newcastle
Border Medical Oncology
Queensland
Townsville Hospital
South Australia
Flinders Medical Centre
Tasmania
Royal Hobart Hospital
Victoria
Peter MacCallum Cancer Centre
The University Hospital, Geelong
Monash Medical Centre
Western Australia
St John of God Hospital, Subiaco
Fiona Stanley Hospital

Key Eligibility Criteria

Please note that the information below contains only the most important inclusion and exclusion criteria and is not a comprehensive list.

Key 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

Key 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

Visit ANZTCR for more detailed information on inclusion/exclusion criteria and eligibility.

Contact Email

nabnec@ctc.usyd.edu.au

Principal Investigator

Dr Mustafa Khasraw (Northern Cancer Institute, Sydney)

More Information

Available online at the Australian New Zealand Clinical Trial Registry (ANZCTR) here.

Funding

National Health and Medical Research Council (NHMRC)