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A Feasibility Study Of NAB-Paclitaxel In Combination With Carboplatin As First Line Treatment Of Gastrointestinal Neuroendocrine Carcinomas (NABNEC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02215447
Recruitment Status : Active, not recruiting
First Posted : August 13, 2014
Last Update Posted : November 22, 2017
Sponsor:
Collaborators:
Specialised Therapeutics Australia
Deakin University
Australasian Gastro-Intestinal Trials Group
Information provided by (Responsible Party):
Barwon Health

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.


Condition or disease Intervention/treatment Phase
Gastrointestinal Neuroendocrine Carcinomas Drug: NAB paclitaxel Drug: Carboplatin Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Feasibility Study Of NAB-Paclitaxel In Combination With Carboplatin As First Line Treatment Of Gastrointestinal Neuroendocrine Carcinomas
Actual Study Start Date : May 2015
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Drug: 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.
Other Name: Abraxane

Drug: Carboplatin



Primary Outcome Measures :
  1. Response rate [ Time Frame: 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 ]
    The objective tumour response rate (partial or complete response as defined by Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1) via CT until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months


Secondary Outcome Measures :
  1. Progression free survival [ Time Frame: 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 ]
    The rate of progression free survival (PFS). (PFS defined from time of registration to disease progression as defined by Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1).

  2. Overall survival [ Time Frame: From date of registration until date of death from any cause, assessed up to 36 months ]
    Overall survival (OS) (death from any cause).

  3. Rates of adverse events as defined by NCI- Common Terminology Criteria for Adverse Events (CTCAE) V4.0 [ Time Frame: During study drug administration until 30 days after last study drug dose ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02215447


Locations
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Australia, New South Wales
Royal North Shore Hospital
St Leonards, New South Wales, Australia, 2065
Australia, Victoria
Barwon Health
Geelong, Victoria, Australia, 3220
Royal Melbourne Hospital
Parkville, Victoria, Australia, 3050
Sponsors and Collaborators
Barwon Health
Specialised Therapeutics Australia
Deakin University
Australasian Gastro-Intestinal Trials Group
Investigators
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Study Chair: Mustafa Khasraw, MD Barwon Health

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Responsible Party: Barwon Health
ClinicalTrials.gov Identifier: NCT02215447    
Other Study ID Numbers: ALCC 14.01
First Posted: August 13, 2014    Key Record Dates
Last Update Posted: November 22, 2017
Last Verified: November 2017
Keywords provided by Barwon Health:
NAB-paclitaxel
Gastrointestinal Neuroendocrine Carcinomas
phase II
carboplatin
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Neuroendocrine
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Adenocarcinoma
Neoplasms, Nerve Tissue
Paclitaxel
Albumin-Bound Paclitaxel
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action