Study of everolimus treatment in newly-diagnosed patients with advanced GI neuroendocrine tumors
- Conditions
- Well or moderately differentiated advanced (metastatic or unresectable) GI or pancreatic neuroendocrine tumors.MedDRA version: 14.1Level: LLTClassification code 10062476Term: Neuroendocrine tumorSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2011-006160-48-GR
- Lead Sponsor
- Hellenic Cooperative Oncology Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 29
1.Male or female, aged =18 years of age.
2.Newly diagnosed patients with biopsy-proven well or moderately differentiated advanced (metastatic or unrectable) GI or pancreatic neuroendocrine tumor.
3.Measurable disease based on R?CIST 1.1 using a triphase CT scan or multi-phase MRI scan.
4.Patients with a ki-67 measurement prior to their enrollment to the study.
5.Performance status 0-2 on the WHO scale.
6.Adequate bone marrow function as shown by:ANC = 1.5 x 10^9/L,Platelets = 100 x 10^9/L,Hemoglobin >9 g/dL.
7.Adequate liver function as shown by:Serum bilirubin = 1.5 x ULN,ALT/SGPT and AST/SGOT = 2.5 x ULN (? = 5 x ULN in patients with known liver metastases),INR < 1.3 (INR < 3 in patients treated with anticoagulants).
8.Adequate renal function as shown by: serum creatinine = 1.5 x ULN.
9.Fasting serum cholesterol = 300 mg/dL or = 7.75 mmol/L and fasting triglycerides = 2.5 x ULN. Note: In case one or both the above upper limits are exceeded, patient enrollment can only be performed upon proper antilipidemic treatment initiation.
10.Women of childbearing potential, with a negative serum or urine pregnancy test within 48 hours prior to first study treatment administration.
11.Signed informed consent form obtained before any trial related activity, including the screening phase, according to the applicable law and ICH/GCP requirements.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 27
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2
1.Patients with poorly differentiated or undifferentiated GI or pancreatic neuroendocrine carcinoma.
2.Previous or concurrent cytotoxic chemotherapy, immunotherapy or radiotherapy.
3.Hepatic artery embolization or cryoablation of hepatic metastasis within 1 month of study enrollment.
4.Prior therapy with mTOR inhibitors (for example sirolimus, temsirolimus, everolimus).
5.Patients receiving chronic treatment with corticosteroid immunosuppressives.
6.Uncontrolled diabetes mellitus as defined by fasting serum glucose > 1.5 x ULN.
7.Patients who have any severe and/or uncontrolled medical conditions such as:
·unstable angina pectoris, symptomatic congestive heart failure NYHA class II, III, IV, myocardial infarction = 6 months prior to enrollment, serious uncontrolled cardiac arrhythmia (LVEF < 50 %)
·active or uncontrolled severe infection
·cirrhosis, chronic active hepatitis, chronic persistent hepatitis or inadequate hepatic function (ALT/SGPT and AST/SGOT > 5 x ULN)
·inadequate bone marrow (ANC < 1.5 x 10^9/L, platelets < 100 x 10^9/L, hemoglobin = 9 g/dL) or renal failure (serum creatinine > 1.5 x ULN
·severely impaired lung function (patients needing oxygen support).
8.Active bleeding diathesis or on oral treatment with vitamin K antagonists (apart from low-dose coumadine).
9.Performance status =3 on the WHO scale.
10.Patients with a known history of HIV seropositivity. Screening for HIV infection at baseline is not required.
11.No other prior or concurrent malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, or treated in situ cancer of the cervix, or any other cancer from which the patient has been disease free for = 3 years.
12.Patients within 28 days post-major surgery (e.g. intra-thoracic, intra-abdominal or intra-pelvic), open biopsy, or significant traumatic injury to avoid wound healing complications. Minor procedures and percutaneous biopsies or placement of vascular access device require 7 days prior to study entry. Note: Patients must have recovered from the acute effects of surgery prior to enrollment.
13.Female patients who are pregnant or nursing (lactating).
14.Adults with reproductive potential who are not using effective birth control methods. If barrier contraceptive measures are being used, these must be continued throughout the study by both sexes.
15.Patients participating in another clinical trial or receiving an investigational drug.
16.Patients unwilling or unable to comply with the protocol at the investigator’s discretion.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate 15month progression-free survival rate (15month PFS rate) (according to RECIST 1.1) in newly-diagnosed patients with advanced or unresectable GI and pancreatic neuroendocrine tumors treated with everolimus as a first-line treatment. ;Secondary Objective: •To evaluate progression free survival (PFS) and overall survival (OS)<br>•To evaluate best overall response during the study and the time to best overall response achievement.<br>•To evaluate the safety of everolimus as a first-line treatment.<br>•To evaluate the possible correlation between biomarkers and disease progression.;Primary end point(s): To evaluate the time of progression-free survival (PFS) and determine the rate of PFS patients at 15 months of treatment. ;Timepoint(s) of evaluation of this end point: 15 months
- Secondary Outcome Measures
Name Time Method