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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02215447




Registration number
NCT02215447
Ethics application status
Date submitted
7/08/2014
Date registered
13/08/2014
Date last updated
22/11/2017

Titles & IDs
Public title
A Feasibility Study Of NAB-Paclitaxel In Combination With Carboplatin As First Line Treatment Of Gastrointestinal Neuroendocrine Carcinomas
Scientific title
A Feasibility Study Of NAB-Paclitaxel In Combination With Carboplatin As First Line Treatment Of Gastrointestinal Neuroendocrine Carcinomas
Secondary ID [1] 0 0
ALCC 14.01
Universal Trial Number (UTN)
Trial acronym
NABNEC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastrointestinal Neuroendocrine Carcinomas 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Neuroendocrine tumour (NET)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - NAB paclitaxel

Experimental: NAB-Paclitaxel with carboplatin - NAB paclitaxel (100 mg/m2 IVI) every week (d1,8,15) in three weekly cycle. Carboplatin (AUC=5 IVI) (d1) in three weekly cycle. Study treatment will continue until progressive disease, unacceptable toxicity, or ceased by patient or clinician preference.


Treatment: Drugs: NAB paclitaxel
100 mg/m2 i.v. every week (d1,8,15) in three weekly cycle Number of Cycles: until progression or unacceptable toxicity develops.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Response rate
Timepoint [1] 0 0
From date of registration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
Secondary outcome [1] 0 0
Progression free survival
Timepoint [1] 0 0
From date of registration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
Secondary outcome [2] 0 0
Overall survival
Timepoint [2] 0 0
From date of registration until date of death from any cause, assessed up to 36 months
Secondary outcome [3] 0 0
Rates of adverse events as defined by NCI- Common Terminology Criteria for Adverse Events (CTCAE) V4.0
Timepoint [3] 0 0
During study drug administration until 30 days after last study drug dose

Eligibility
Key inclusion criteria
* 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/10/2020
Actual
Sample size
Target
Accrual to date
Final
4
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [2] 0 0
Barwon Health - Geelong
Recruitment hospital [3] 0 0
Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
2065 - St Leonards
Recruitment postcode(s) [2] 0 0
3220 - Geelong
Recruitment postcode(s) [3] 0 0
3050 - Parkville

Funding & Sponsors
Primary sponsor type
Government body
Name
Barwon Health
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Specialised Therapeutics Australia
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Deakin University
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Australasian Gastro-Intestinal Trials Group
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
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 controlled trials, but many of which still require high quality clinical trial evidence to confirm their effectiveness and guide their use in practice. This study is the first prospective trial to evaluate modern combination chemotherapy. The study will determine whether Carboplatin and Paclitaxel NAB is a suitable combination for comparison in a subsequent randomised controlled phase III international trial.

Given the paucity of randomized studies in NETs, there are no clear evidence based guidelines. Patients are treated according to guidelines established for small cell lung cancer, incorporating platinum (cisplatin or carboplatin) based doublet treatment with etoposide. Although these tumors are initially highly chemosensitive, the natural history of this disease is such that relapses occur early, which ultimately leads to a very poor prognosis. Almost all clinical trials investigating cytotoxic chemotherapy in NETs are small single arm studies and guidelines are derived from expert opinion and from extrapolating results from small cell lung cancer studies. Prospective clinical trials in this group of patients needs to be conducted to establish an evidence based standard of care and to improve the prognosis of this highly aggressive group of tumors.

Participants will receive albumin bound paclitaxel (ABRAXANE®) 100 mg/m2 administered as an intravenous infusion over 30 minutes on Days 1, 8, and 15 of each 21 day cycle. Carboplatin will be given at an Area Under the Curve (AUC) = 5 mg/min/mL on Day 1 only of each 21 day cycle administered over 30 mins, beginning immediately after the completion of albumin bound paclitaxel administration. Participants can continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
Trial website
https://clinicaltrials.gov/study/NCT02215447
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Mustafa Khasraw, MD
Address 0 0
Barwon Health
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02215447