Clinical Trial: A Feasibility Study Of NAB-Paclitaxel In Combination With Carboplatin As First Line Treatment Of Gastrointestinal Neuroendocrine Carcinomas

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Feasibility Study Of NAB-Paclitaxel In Combination With Carboplatin As First Line Treatment Of Gastrointestinal Neuroendocrine Carcinomas

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 a

Detailed Summary:

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 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. Given the paucity of randomized studies in neuroendocrine carcinomas (NECs), there are no clear evidence based guidelines. Patients are treated according to guidelines established for small cell lung cancer. 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. Prospective clinical trials in this group of patients needs to be conducted to establish an evidence based standard of care and to improve prognosis. NETs are a heterogeneous group of malignancies originating from cells of the neural. They have a variable and often long natural history. They commonly arise from the gastrointestinal tract (58%), pancreas or lung (27%), and low grade NETs can be associated with symptoms resulting from the secretion of hormones or vasoactive peptides. NETs used to be thought of as rare but recently have been shown to be more common with rising incidence rates (3.3/100,000 in Australia 2000-2006). Prevalence (35/100, 000) is much higher than incidence resulting from five year survivorship of ~ 60% resulting in NETs being more prevalent than either gastric, pancreatic, oesophageal or hepatobiliary adenocarcinomas, or any 2 of these cancers combined. They can present multiple complex clinical challenges, thereby significantly contributing to cancer related morbidity and health costs in the Australian population. More recently, international interest groups such as the European Neuroendocrine Tumor Society have i
Sponsor: Barwon Health

Current Primary Outcome: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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).
  • 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).
  • 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 ]


Original Secondary Outcome: Same as current

Information By: Barwon Health

Dates:
Date Received: August 7, 2014
Date Started: May 2015
Date Completion: October 2020
Last Updated: February 15, 2017
Last Verified: August 2016