A Feasibility Study Of NAB-Paclitaxel In Combination With Carboplatin As First Line Treatment Of Gastrointestinal Neuroendocrine Carcinomas (NABNEC)
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|ClinicalTrials.gov Identifier: NCT02215447|
Recruitment Status : Active, not recruiting
First Posted : August 13, 2014
Last Update Posted : November 22, 2017
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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
- 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 ]
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
|Australia, New South Wales|
|Royal North Shore Hospital|
|St Leonards, New South Wales, Australia, 2065|
|Geelong, Victoria, Australia, 3220|
|Royal Melbourne Hospital|
|Parkville, Victoria, Australia, 3050|
|Study Chair:||Mustafa Khasraw, MD||Barwon Health|