A Randomised Phase II Study Of nab-paclitaxel In Combination With Carboplatin As First Line Treatment Of Gastrointestinal Neuroendocrine Carcinomas

Phase 2

Active, not recruiting

• Conditions: Gastrointestinal Neuroendocrine Carcinomas; Cancer - Neuroendocrine tumour (NET)

• Registration Number: ACTRN12616000958482
• Lead Sponsor: Australasian Gastro-Intestinal Trials Group (AGITG)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-07-21
• Last Update Posted: 23 May 2022

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Adults, aged 18 years and older, with advanced and/or metastatic, unresectable neuroendocrine carcinoma
-Histologically proven (WHO/ ENET) Grade 3 NEC with Ki-67 greater than 20%. (The features of small versus large cell NEC carcinoma will need to be documented and participants with Mixed AdenoneuroEndocrine Carcinomas (MANEC) are eligible if they have G3 elements)
-Tumour sufficiently FDG-avid on the initial staging PET Scan (e.g. SUVmax greater than or equal to 3.5). If avidity is borderline or unclear then contact the NHMRC CTC and Study Chair.
-Measurable disease as assessed by CT scan of the chest, abdomen and pelvis within 21 days prior to randomisation (according to RECIST 1.1)
-ECOG performance status 0-2
-Adequate bone marrow function (platelets greater than 100 x 109/L; ANC greater than 2 x 109/L; haemoglobin greater than 100 x g/L)
-Adequate liver function (total bilirubin less than or equal to 1.5 x ULN, ALT/AST less than or equal to 3 × ULN). For participants with liver metastases use the following ULN: total bilirubin less than or equal to 3 x ULN, ALT/AST less than or equal to 5 × ULN. NB; Patients with inadequate liver function and liver metastases who satisfy all other eligibility criteria may start on a reduced dose level (-1 dose level; see table 5.2.1), upon approval by the Study Chair or delegate. Doses can be increased to the standard starting doses if AST/ALT normalise.
-Adequate renal function (creatinine less than or equal to 1.5 ULN)
-Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments
-Signed, written informed consent (main study)

Exclusion Criteria

-NECs confirmed not to be from gastrointestinal primaries
-Grade 1 and Grade 2 NETs (Ki-67 less than or equal to 20%)
-Suspected pulmonary origin of the NET
-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 randomization.
-Prior intrahepatic 90Y-microspheres such as SIR-Spheres
-Major surgery/surgical therapy for any cause within 1 month
-Surgical therapy of loco-regional metastases within the last 3 months prior to randomization
-Severe cardiovascular, hepatic, neurologic or renal comorbid conditions
-Previous cytotoxic chemotherapy, or targeted therapy, or biotherapy within the last 4 weeks (excluding SSAs)
-Significant infection, including chronic active hepatitis B, hepatitis C, or HIV. Testing for these is not mandatory unless clinically indicated
-Sensory/motor neuropathy greater than or equal to G2, as defined by NCI CTCAE 4.0
-Life expectancy of less than 3 months
-History of another malignancy within 2 years prior to registration. Patients with a past history of adequately treated carcinoma-in-situ, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or superficial transitional cell carcinoma of the bladder are eligible. Patients with a history of other malignancies are eligible if they have been continuously disease free for at least 2 years after definitive primary treatment, or in the case of stage 1 tumour/s are undergoing curative resection and there is no indication for chemo- or radiotherapy.
-Serious medical or psychiatric conditions that might limit the ability of the patient to comply with the protocol
-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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine objective tumour response rate (RR) (partial or complete response as defined by RECIST criteria version 1.1).[The time point for objective tumour response rate (RR is 6 months after the last patient has been enrolled)]