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Gastrointestinal TumorsPhase 2NCT01648465

Study of Everolimus Treatment in Newly-diagnosed Patients With Advanced Gastrointestinal Neuroendocrine Tumors

A Phase 2 study testing Everolimus in people with Gastrointestinal Tumors and Pancreatic Tumors, run by Hellenic Cooperative Oncology Group at 12 sites in Greece.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to explore the efficacy and safety of everolimus administered as a first-line treatment in newly-diagnosed patients with advanced or inoperable Gastrointestinal (GI) or pancreatic neuroendocrine tumors. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Everolimus
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
12 sitesGreece
Study dates
6 Aug 2012to 6 Aug 2019
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female, aged ≥ 18 years of age.
  • Newly diagnosed patients with biopsy-proven well or moderately differentiated advanced (metastatic or unresectable) GI or pancreatic neuroendocrine tumor.
  • Measurable disease based on RΕCIST 1.1 using a triphase CT scan or multi-phase MRI scan.
  • Patients with a ki-67 measurement <20% prior to their enrollment to the study.
  • Performance status 0-2 on the WHO scale.
  • Adequate bone marrow function as shown by:ANC ≥ 1.5 x 10^9/L,Platelets ≥ 100 x 10^9/L,Hemoglobin > 9 g/dL.
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  • Adequate liver function as shown by:Serum bilirubin ≤ 1.5 x ULN,ALT/SGPT and AST/SGOT ≤ 2.5 x ULN (ή ≤ 5 x ULN in patients with known liver metastases),INR < 1.3 (INR < 3 in patients treated with anticoagulants).
  • Adequate renal function as shown by: serum creatinine ≤ 1.5 x ULN.
  • 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.
  • Women of childbearing potential, with a negative serum or urine pregnancy test within 48 hours prior to first study treatment administration.
  • Signed informed consent form obtained before any trial related activity, including the screening phase, according to the applicable law and ICH/GCP requirements.
  • Signed informed consent for the use of biological and genetic material

Who cannot join

  • Patients with poorly differentiated or undifferentiated GI or pancreatic neuroendocrine carcinoma.
  • Previous or concurrent cytotoxic chemotherapy, immunotherapy or radiotherapy.
  • Hepatic artery embolization or cryoablation of hepatic metastasis within 1 month of study enrollment.
  • Prior therapy with mTOR inhibitors (for example sirolimus, temsirolimus, everolimus).
  • Patients receiving chronic treatment with corticosteroid immunosuppressives.
  • Uncontrolled diabetes mellitus as defined by fasting serum glucose > 1.5 x ULN.
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  • 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).
  • Active bleeding diathesis or on oral treatment with vitamin K antagonists (apart from low-dose coumadine).
  • Performance status ≥ 3 on the WHO scale.
  • Patients with a known history of HIV seropositivity. Screening for HIV infection at baseline is not required.
  • 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.
  • Patients within 28 days post-major surgery (e.g. intra-thoracic, intrabdominal 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.
  • Female patients who are pregnant or nursing (lactating).
  • 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.
  • Patients participating in another clinical trial or receiving an investigational drug.
  • Patients unwilling or unable to comply with the protocol at the investigator's discretion.

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

Greece12 sites

  • 2nd Dept of Internal Medicine, Agios Savvas Cancer Hospital

    Athens, 11522

  • Dept of Medical Oncology, 251 General Airforce Hospital

    Athens, 11525

  • 2nd Dept of Internal Medicine, General Hospital of Athens "Hippokratio"

    Athens, 11527

  • 2nd Dept of Internal Medicine, Propaedeutic, University Hospital "Attikon"

    Athens, 12462

  • 4th Dept of Internal Medicine, University Hospital "Attiko"

    Athens, 12462

  • 3rd Dept of Medical Oncology, Agii Anargiri Cancer Hospital

    Athens, 14564

  • 2nd Dept of Medical Oncology, Metropolitan Hospital

    Athens, 18547

  • Dept of Medical Oncology, University Hospital of Heraklion

    Heraklion, 71110

  • Dept of Medical Oncology, Ioannina University Hospital

    Ioannina, 45110

  • Division of Oncology, Dept of Internal Medicine, University Hospital of Patras

    Pátrai, 26504

  • Dept of Medical Oncology, Papageorgiou General Hospital

    Thessaloniki, 56429

  • Dept of Medical Oncology, Thermi Clinic

    Thessaloniki, 57001

Other trials in Greece

About this study

Official title: Phase II Multicenter Single-arm Study Evaluating the Safety and Efficacy of Everolimus as a First-line Treatment in Newly-diagnosed Patients With Advanced GI Neuroendocrine Tumors.

The purpose of this study is to explore the efficacy and safety of everolimus administered as a first-line treatment in newly-diagnosed patients with advanced or inoperable Gastrointestinal (GI) or pancreatic neuroendocrine tumors.

Being tested
Everolimus
Keywords
metastatic, unresectable, well or moderately differentiated, advanced
Medical subject headings
Digestive System Neoplasms, Pancreatic Neoplasms, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EverolimusDrug

    Also called Afinitor, RAD001

    Everolimus 10mg(2x5mg)orally once daily until disease progression, unacceptable toxicity or consent withdrawal

Study groups in NCT01648465
Study groupRoleWhat they receive
EverolimusExperimentalNot described
Receives: Drug: Everolimus

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 15 month PFS (Progression-Free Survival) rate

    To determine the rate of PFS patients at 15 months of treatment.

    Measured: 15 months

Secondary outcomes (5)

  1. Progression-Free Survival (PFS)

    Measured: Defined as the time from the date of enrollment to the date of 1st radiologically documented disease progression or disease related death,assessed up to 36 months.

  2. Overall Survival (OS)

    Measured: Defined as the time from the date of enrollment to the date of death from any cause,assessed up to 36 months.

  3. Evaluation of best response to treatment and the time to best response achievement

    Measured: Defined as the period from the date of treatment initiation to best response observation date througout the study, assessed up to 15 months.

  4. Assessment of safety

    Measured: Assessment of adverse events will be performed every 28 days (per cycle) during treatment, assessed up to 16 months.

  5. Association of biologic markers with disease progression

    Measured: Up to 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jul 2012 (estimated)
  2. Study start6 Aug 2012
  3. Primary completionJan 2017
  4. Study completion6 Aug 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01648465
Sponsor's protocol ID
HE 67/12
Other IDs
2011-006160-48
Status last verified
Aug 2019
First submitted
13 Jul 2012
Last updated
3 Sep 2019
Results posted
No
Data monitoring committee
No

Publications

  • Koumarianou A, Pectasides D, Koliou GA, Dionysopoulos D, Kolomodi D, Poulios C, Skondra M, Sgouros J, Pentheroudakis G, Kaltsas G, Fountzilas G. Efficacy and Safety of First-Line Everolimus Therapy Alone or in Combination with Octreotide in Gastroenteropancreatic Neuroendocrine Tumors. A Hellenic Cooperative Oncology Group (HeCOG) Study. Biology (Basel). 2020 Mar 9;9(3):51. doi: 10.3390/biology9030051.

    PubMed 32182791

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Everolimus in people with Gastrointestinal Tumors and Pancreatic Tumors, run by Hellenic Cooperative Oncology Group at 12 sites in Greece.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 3 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

15 month PFS (Progression-Free Survival) rate (time frame: 15 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01648465, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2019.

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