MedTrace Logo

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

NCT02215447 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2017-11-22

No results posted yet for this study

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.

Conditions

  • Gastrointestinal Neuroendocrine Carcinomas

Interventions

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.

DRUG

Carboplatin

Sponsors & Collaborators

  • Specialised Therapeutics Australia

    collaborator UNKNOWN

  • Deakin University

    collaborator OTHER

  • Australasian Gastro-Intestinal Trials Group

    collaborator NETWORK

  • Barwon Health

    lead OTHER_GOV

Principal Investigators

  • Mustafa Khasraw, MD · Barwon Health

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2018-11-30
Completion
2020-10-31

Countries

  • Australia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02215447 on ClinicalTrials.gov