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Carcinoid TumorsPhase 2SUNLANDNCT01731925

A Study of Sunitinib Versus Placebo in Combination With Lanreotide in Patients With Progressive Advanced/Metastatic Midgut Carcinoid Tumors

A Phase 2 study testing Lanreotide and Sunitinib in people with Carcinoid Tumors, run by GERCOR - Multidisciplinary Oncology Cooperative Group at 20 sites in 2 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Sunitinib may provide an opportunity for a novel therapeutic strategy for the treatment of subjects with neuroendocrine tumors. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoid Tumors
What is being tested?
Lanreotide and Sunitinib
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
44 participants
Where
20 sitesin 2 countries
Study dates
7 Jan 2013to Dec 2017
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

  • Patients with midgut well-differentiated Grade 1-2 endocrine tumor.
  • Local, locally advanced or metastatic disease documented as progressive by RECIST v1.1. on CT-scan or MRI at baseline and within 12 months prior to baseline.
  • 5HIAA levels superior to 1.5ULN as measured in each individual centre.
  • Disease that is not amenable to surgery with curative intent.
  • Presence of at least one measurable target lesion for further evaluation according to RECIST v1.1
  • Adequate organ function
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  • ECOG Performance status 0 or 1.
  • Life expectancy superior or equal to 3 months.
  • Age superior or equal to 18 years.
  • Female patients must be surgically sterile or be postmenopausal, or must agree to use effective contraception during the period of therapy. All female patients with reproductive potential must have a negative pregnancy test (serum or urine) within 7 days prior to enrollment. Breast feeding is not allowed. Male patients must be surgically sterile or must agree to use effective contraception during the period of therapy. The definition of effective contraception will be based on the judgment of the principal investigator or a designated associate.
  • Able to swallow oral compound.
  • Signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the trial prior to enrollment.
  • Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other study procedures.
  • Registration in a national health care system (CMU included).

Who cannot join

  • Patients with undifferentiated, poorly differentiated gastrointestinal neuroendocrine tumors, pancreatic neuroendocrine tumors, bronchial carcinoid tumors.
  • Patients with carcinoid tumors with the presence of an obstructive intestinal tumor.
  • Patients with uncontrolled cardiac complication as part of their carcinoid syndrome.
  • Current treatment with any chemotherapy, chemoembolization therapy, immunotherapy, or investigational anticancer agent
  • Current treatment with dose superior or equal to 120 mg per month of lanreotide
  • Prior treatment with any tyrosine kinase inhibitors or anti-VEGF angiogenic inhibitors. Prior treatment with non-VEGF-targeted angiogenic inhibitors such as everolimus or temsirolimus is permitted.
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  • Patients who stopped everolimus treatment was less than 4 weeks prior to randomization.
  • Patients with concomitant treatment with interferon.
  • Patients previously treated with chemotherapy, loco-regional therapy (e.g., chemoembolization) or interferon with last administration less than 6 weeks prior to randomization or with toxicity not resolved to less or equal grade 1 at randomization.
  • Diagnosis of any second malignancy within the last 5 years, except for adequately treated basal cell or squamous cell skin cancer, or in situ carcinoma of the cervix uteri.
  • Treatment with potent CYP3A4 inhibitors and inducers within 7 and 12 days, respectively prior to study drug administration.
  • Concomitant treatment with therapeutic doses of anticoagulants
  • Concomitant treatment with a drug having proarrhythmic potential
  • Unstable systemic diseases including uncontrolled hypertension or active uncontrolled infections.
  • Current treatment on another clinical trial.
  • Any of the following within the 12 months prior to study drug administration: myocardial infarction, severe/unstable angina, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism.
  • Ongoing cardiac dysrhythmias of NCI CTC grade superior or equal to 2, atrial fibrillation of any grade, or prolongation of the QTc interval to more than 450 msec for males or more than 470 msec for females.
  • Symptomatic brain metastases, spinal cord compression, or new evidence of brain or leptomeningeal disease.
  • Left ventricular ejection fraction inferior or equal 50% as measured by either multigated acquisition scan or echocardiogram.
  • Positive test for human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) related illness.
  • Patients with complicated, untreated lithiasis of the bile ducts
  • Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study.

Trial locations and contacts

20 sites in 2 countries.

20 sites in 2 countries

France14 sites

  • Hôpital Saint André

    Bordeaux, 33075

  • Hôpital Beaujon

    Clichy, 92118

  • Hôpital Henri Mondor

    Créteil

  • Hopital Saint Vincent de Paul

    Lille, 59020

  • Hôpital Edouard Herriot

    Lyon, 69437

  • CHU La Timone

    Marseille, 13005

  • Hôpital St Antoine

    Paris, 75012

  • CHU Cochin

    Paris

  • Hôpital Pitié Salpêtrière

    Paris

  • Institut Mutualiste Montsouris

    Paris

  • CHU Robert Debré

    Reims

  • CHU Pontchaillou

    Rennes

  • CHU Rouen

    Rouen

  • CHRU Trousseau

    Tours

Other trials in France

Belgium6 sites

  • Cliniques Universitaires Saint Luc

    Brussels

  • Institut Jules Bordet

    Brussels

  • ULB Erasme

    Brussels

  • UZ Antwerpen

    Edegem

  • UZ Gent

    Ghent

  • UZ Leuven

    Leuven

Other trials in Belgium

About this study

Official title: A RANDOMIZED PHASE II DOUBLE-BLIND TRIAL OF SUNITINIB VERSUS PLACEBO IN COMBINATION WITH LANREOTIDE IN PATIENTS WITH PROGRESSIVE ADVANCED/METASTATIC MIDGUT CARCINOID TUMORS

Sunitinib may provide an opportunity for a novel therapeutic strategy for the treatment of subjects with neuroendocrine tumors.

Read the detailed description

With the exception of surgery for localized disease, there is presently a lack of available therapies with proven survival benefit for patients with neuroendocrine tumors (NET). Available treatment options for unresectable disease include the use of somatostatin analogs, which may relieve symptoms related to hormonal hypersecretion. The efficacy of cytotoxic chemotherapy in patients with metastatic carcinoid tumors is also limited. Combinations of either streptozocin and cyclophosphamide, or streptozocin and 5-fluorouracil, appear to be inactive, and both regimens are associated with substantial toxicity.

Receptor tyrosine kinases (RTKs) are implicated in deregulated/ autocrine proliferation and survival of solid and hematologic cancer cells. Sunitinib malate is an orally administered small molecule that inhibits the tyrosine kinase enzymatic activities of the receptors for VEGF and PDGF, and also blocks signalling through the KIT, FLT3 and RET pathways.

Therefore, sunitinib malate may provide an opportunity for a novel therapeutic strategy for the treatment of subjects with NET.

Being tested
Lanreotide, Placebo (for sunitinib), Sunitinib
Keywords
midgut carcinoid tumors, progressive, advanced, metastatic
Medical subject headings
Carcinoid Tumor, Neoplasm Metastasis

What participants receive

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

  • LanreotideDrug

    Lanreotide at the dose of 120 mg will be injected every 28 days as the reference treatment to control the carcinoid syndrome in both arms.

  • Placebo (for sunitinib)Drug

  • SunitinibDrug

    Sunitinib 37.5 mg daily

Study groups in NCT01731925
Study groupRoleWhat they receive
SunitinibExperimentalSunitinib 37.5 mg daily. Lanreotide at the dose of 120 mg will be injected every 28 days as the reference treatment to control the carcinoid syndrome in both arms.
Receives: Drug: Lanreotide; Drug: Sunitinib
PlaceboPlacebo comparatorPlacebo (for sunitinib). Lanreotide at the dose of 120 mg will be injected every 28 days as the reference treatment to control the carcinoid syndrome in both arms.
Receives: Drug: Lanreotide; Drug: Placebo (for sunitinib)

What is being measured

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

  1. Progression free survival (PFS)

    To evaluate the efficacy of the combination of sunitinib malate with lanreotide acetate and of placebo with lanreotide acetate regarding progression-free-survival (PFS) as assessed by the investigator, in patients suffering from progressive, advanced/metastatic midgut carcinoid tumors.

    Measured: time from date of randomization to first progression of disease (PD) or death for any reason in the absence of documented PD, assessed up to 3 years after the beginning of the study

Secondary outcomes (7)

  1. Overall survival (OS)

    To evaluate overall survival (OS) in sunitinib- and placebo-treated subjects.

    Measured: time from date of randomization to date of death, assessed up to 3 years after the beginning of the study

  2. Objective response (OR)

    To evaluate objective response (OR) rate in sunitinib- and placebo-treated subjects.

    Measured: from randomization until disease progression, assessed up to 3 years after the beginning of the study

  3. Duration of response (DR)

    To evaluate duration of response (DR) in sunitinib- and placebo-treated subjects in subjects achieving a response.

    Measured: time from CR or PR to objective tumor progression or to death due to any cause, whichever occurs first, assessed up to 3 years after the beginning of the study

  4. Time to tumor response (TTR)

    To assess time to tumor response (TTR) for sunitinib- and placebo-treated subjects.

    Measured: time from date of randomization to first documentation of objective tumor response that is subsequently confirmed.assessed up to 3 years after the beginning of the study

  5. Biological responses

    To evaluate the best biological responses as assessed using serum chromogranin A and urine 5HIAA for sunitinib- and placebo-treated subjects.

    Measured: from baseline to end of treatment, assessed up to 3 years after the beginning of the study

  6. Safety

    To assess safety and tolerability of sunitinib in the study population.

    Measured: from visit 1 to 1 month after last study drug administration, assessed up to 3 years after the beginning of the study

  7. Quality of life

    To assess Health related Quality of life (EORTC QLQ C-30).

    Measured: From screening to 1 month after last study drug administration, assessed up to 3 years after the beginning of the study

Timeline

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

  1. First posted22 Nov 2012 (estimated)
  2. Study start7 Jan 2013
  3. Primary completionDec 2017 (estimated)
  4. Study completionDec 2017 (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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01731925
Sponsor's protocol ID
SUNLAND D12-01
Other IDs
2012-001098-94
Acronym
SUNLAND
Status last verified
Jan 2017
First submitted
19 Nov 2012
Last updated
31 Jan 2017
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lanreotide and Sunitinib in people with Carcinoid Tumors, run by GERCOR - Multidisciplinary Oncology Cooperative Group at 20 sites in 2 countries.

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 14 inclusion and 22 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: status not confirmed, as of the sponsor's last update on 31 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in France, 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. Some participants in this study may receive a placebo. 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?

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?

Progression free survival (PFS) (time frame: time from date of randomization to first progression of disease (PD) or death for any reason in the absence of documented PD, assessed up to 3 years after the beginning of the study). 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 NCT01731925.

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 31 Jan 2017.

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