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Gastro-intestinal Neuroendocrine TumorsPhase 3CASTORNCT01860742

Randomized Phase III of PRRT Versus Interferon

A Phase 3 study testing Interferon alpha-2b and 177Lu-DOTATATE in people with Gastro-intestinal Neuroendocrine Tumors, run by Jules Bordet Institute at 2 sites in Belgium.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The purpose of this study is to assess the benefit of 177Lu-DOTATATE versus interferon α-2b in patients with progressive, unresectable, non-pancreatic gastrointestinal neuroendocrine tumors resistant to therapy with somatostatin analogues, in terms of disease control. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gastro-intestinal Neuroendocrine Tumors
What is being tested?
Interferon alpha-2b and 177Lu-DOTATATE
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
2 sitesBelgium
Study dates
Dec 2014to Oct 2016
Phase
Phase 3
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

  • Adult patients (≥ 18 yrs).
  • Histology-proven non-pancreatic gastrointestinal NETs.
  • Disease progression under SSAs (SSAs-resistant disease). Disease progression must be documented with at least one of the following:
  • Radiological disease progression (according to RECIST 1.1) on an MRI or CT over the last 12 months.
  • Disease progression on a somatostatin receptor-imaging (PET/CT or SPECT/CT) over the last 12 months (apparition of new lesion(s) or increase in the transaxial plane diameter of more than 30% on the same imaging modality).
  • There should be at least one target lesion. A target lesion should fulfill all the following criteria:
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  • Uptake higher than the physiological liver uptake on the baseline 68Ga-DOTATATE PET/CT
  • Longest transaxial plane diameter ≥ 20mm measured on the CT or MRI;
  • Not previously irradiated.
  • Long-acting SSAs must be discontinued at least 4 weeks before the study treatment start date and, if needed, switched to short-acting analogues which must be stopped 48h before the treatment date.
  • Adequate renal function with GFR ≥ 50 mL/min/1.73m2 (evaluated by 51Cr-EDTA test).
  • Adequate bone marrow function with:
  • Hemoglobin ≥ 9 g/dL;
  • Neutrophil ≥ 1.5·109/L;
  • Platelet count ≥ 100·109/L.
  • Adequate liver function with:
  • Total Bilirubin ≤ 2xULN;
  • Transaminases (AST and ALT) ≤ 5xULN;
  • Serum albumin > 3.0 g/dL with normal prothrombin time (>70%) unless for patients under coumarin anticoagulation therapy.
  • ECOG Performance Status ≤ 1.
  • Women of childbearing potential and men with partners of childbearing potential must agree to use a highly effective form of contraception for the duration of study participation and up to six months after the end of the treatment. A pregnancy test (serum) must be performed within 2 weeks prior to inclusion for every female patient of childbearing potential and it must be negative.
  • Patient's written informed consent obtained prior to any study specific procedure.
  • All necessary baseline procedures should be performed within 2 weeks prior to randomization date.

Who cannot join

  • Resectable tumor with curative intent.
  • Any major surgery within the last 6 weeks prior to inclusion in the study.
  • Radiotherapy, chemotherapy, embolization, mammalian target of rapamycin (mTOR)-inhibitors, receptor tyrosine-kinase inhibitors or other investigational therapy within 12 weeks prior to inclusion in the study.
  • Previous PRRT or MIBG treatment.
  • Treatment with interferon 12 months prior to inclusion in the study.
  • Presence of non-benign 18FDG-positive lesions (higher than 2 x normal liver (or thoracic aorta uptake -SUVmax- in case of liver involvement)) without significant 68Ga-DOTATATE uptake.
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  • Uncontrolled congestive heart failure (NYHA stade ≥ 2).
  • Diffuse bone marrow infiltration on the baseline 68Ga-DOTATATE PET/CT confirmed by MRI.
  • Prior external beam radiotherapy on kidneys or on more than 25% of bone marrow.
  • Patients with known uncontrolled brain metastases.
  • History of other active malignant disease or clinical remission less than 5 years (except in case of non melanoma skin cancer or in situ cervical carcinoma).
  • Known autoimmune hepatitis.
  • Patients after organ transplantation under immunosuppressive therapy.
  • Patients with a significant medical, neuro-psychiatric, or surgical condition, currently uncontrolled by treatment, which, in the investigator's opinion, may interfere with completion of the study.
  • Hypersensitivity to interferon α-2b or to any component of the product.
  • Pregnant or lactating patients.

Trial locations and contacts

2 sites in 1 country.

Belgium2 sites

  • Jules Bordet Institute

    Brussels, B-1000

  • UZ Leuven

    Leuven, B-3000

Other trials in Belgium

About this study

Official title: Carcinoid Tumors After Failure of Somatostatin Analogs: a Randomized Phase III of Octreotide Lutate Peptid Receptor Radionuclide Therapy (PRRT) Versus Interferon α-2b

The purpose of this study is to assess the benefit of 177Lu-DOTATATE versus interferon α-2b in patients with progressive, unresectable, non-pancreatic gastrointestinal neuroendocrine tumors resistant to therapy with somatostatin analogues, in terms of disease control.

Read the detailed description

This is a phase III study of Peptid Receptor Radionuclide Therapy (PRRT) with 177Lu-DOTATATE versus Interferon α-2b.

Objectives of the study:

  1. To assess the benefit of 177Lu-DOTATATE versus interferon α-2b in patients with progressive, unresectable,non-pancreatic gastrointestinal neuroendocrine tumors, resistant to therapy with somatostatin analogues, in terms of disease control.
  2. To assess efficacy and safety parameters of both treatment arms and the predictive value of tumor 68Ga-DOTATATE PET/CT and 18FDG PET/CT uptake at baseline, at mid (+/- 16th week) and end (+/- 32th week) of treatment in both arms.

In the interferon arm: 5000000 Units of interferon will be administered subcutaneously preferentially in the evening three times a week (every other day) until disease progression.

In the 177Lu-octreotate arm: Treatment will consist of 177Lu-DOTATATE intravenous injections fractionated in fixed activities of 7,4 GigaBecquerel (200mCi) (+/- 5%), given every 8 (+/- 1) weeks with simultaneous nephroprotective infusion of an amino acid solution. (Before amino acid nephroprotection solution, ondansetron, methylprednisolone and metoclopramid, are given in infusions in order to prevent nausea or vomiting). Approximately 30 min after the beginning of the aminoacid solution, 177Lu-octreotate is injected via a second side-line over 15-30 minutes. The amino acid infusion is continued at the same rate until end (total infusion time: 4-6 hours).

In total, 4 injections of 177Lu-DOTATATE are planned. However, in respect of the absorded dose limits of critical organs(kidneys and bone marrow), the 4th 177Lu-DOTATATE injection will be tailored with a minimal administered activity of 4,6 GigaBecquerel.

Treatment efficacy will be assessed on a patient-basis using RECIST 1.1 and by Progression Free Survival. The value of tumor 68Ga-DOTATATE PET/CT and 18FDG PET/CT uptake as predicting imaging biomarkers will also be assessed in both arms.

Being tested
Interferon alpha-2b, 177Lu-DOTATATE
Keywords
Peptide Receptor Radionuclide Therapy (PRRT), Neuroendocrine Tumors, Interferon alpha
Medical subject headings
Neuroendocrine Tumors

What participants receive

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

  • Interferon alpha-2bDrug

    Also called Intron A

    Interferon α-2b in a dose of 5000000 Units administered subcutaneously every second day

  • 177Lu-DOTATATEDrug

    Also called 177Lu-octreotate, Lutate

    177Lu-octreotate infusions in fixed activities of 7,4 GigaBecqurel each, given 8-11 weeks apart, injected intravenously with simultaneous infusion of an amino acid solution

Study groups in NCT01860742
Study groupRoleWhat they receive
Interferon alpha-2bActive comparatorInterferon α-2b in a dose of 5000000 Units administered subcutaneously every second day until progression or unacceptable adverse event from a clinical or a patient point of view.
Receives: Drug: Interferon alpha-2b
177Lu-DOTATATEActive comparatorintravenous injection of 177Lu-octreotate with simultaneous infusion of an aminoacid solution
Receives: Drug: 177Lu-DOTATATE

What is being measured

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

  1. Progression Free Survival (PFS)

    PFS is defined by the time between treatment initiation and the first of the following events:

    • Disease progression according to RECIST 1.1;
    • Death of the patient from any cause;
    • Appearance of confirmed new lesion(s) on 68Ga-DOTATATE PET/CT or 18FDG PET/CT.

    Measured: 3 years [Anticipated]

Secondary outcomes (3)

  1. Treatment response according to RECIST 1.1 (Response Evaluation Criteria In Solid Tumors)

    Measured: 3 years [Anticipated]

  2. Adverse events according to Common Terminology Criteria for Adverse Events version 4.03 (CTC 4.03-WHO criteria)

    Measured: 3 years [Anticipated]

  3. Tumor 18FDG PET/CT and 68Ga-octreotate PET/CT uptake at baseline, at mid and end of treatment

    Measured: 3 years [Anticipated]

Timeline

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

  1. First posted23 May 2013 (estimated)
  2. Study startDec 2014
  3. Primary completionOct 2016 (estimated)
  4. Study completionOct 2016 (estimated)

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01860742
Sponsor's protocol ID
IJBMNCASTOR
Other IDs
2012-005545-20
Acronym
CASTOR
Status last verified
Apr 2016
First submitted
21 May 2013
Last updated
5 Apr 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Interferon alpha-2b and 177Lu-DOTATATE in people with Gastro-intestinal Neuroendocrine Tumors, run by Jules Bordet Institute at 2 sites in Belgium.

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 23 inclusion and 16 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: withdrawn, as of the sponsor's last update on 5 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Belgium. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 withdrawn before enrolling participants, so there are no results.

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?

Progression Free Survival (PFS) (time frame: 3 years [Anticipated]). 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 NCT01860742.

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 5 Apr 2016.

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