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

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Brief Title

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

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

Brief Summary

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

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.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Progression free survival (PFS)

Secondary Outcome

 Overall survival (OS)

Condition

Carcinoid Tumors

Intervention

Lanreotide

Study Arms / Comparison Groups

 Sunitinib
Description:  Sunitinib 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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

44

Start Date

January 7, 2013

Completion Date

December 2017

Primary Completion Date

December 2017

Eligibility Criteria

        Inclusion Criteria:

          1. Patients with midgut well-differentiated Grade 1-2 endocrine tumor.

          2. 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.

          3. 5HIAA levels superior to 1.5ULN as measured in each individual centre.

          4. Disease that is not amenable to surgery with curative intent.

          5. Presence of at least one measurable target lesion for further evaluation according to
             RECIST v1.1

          6. Adequate organ function

          7. ECOG Performance status 0 or 1.

          8. Life expectancy superior or equal to 3 months.

          9. Age superior or equal to 18 years.

         10. 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.

         11. Able to swallow oral compound.

         12. Signed and dated informed consent document indicating that the patient has been
             informed of all pertinent aspects of the trial prior to enrollment.

         13. Willingness and ability to comply with scheduled visits, treatment plans, laboratory
             tests and other study procedures.

         14. Registration in a national health care system (CMU included).

        Exclusion Criteria:

          1. Patients with undifferentiated, poorly differentiated gastrointestinal neuroendocrine
             tumors, pancreatic neuroendocrine tumors, bronchial carcinoid tumors.

          2. Patients with carcinoid tumors with the presence of an obstructive intestinal tumor.

          3. Patients with uncontrolled cardiac complication as part of their carcinoid syndrome.

          4. Current treatment with any chemotherapy, chemoembolization therapy, immunotherapy, or
             investigational anticancer agent

          5. Current treatment with dose superior or equal to 120 mg per month of lanreotide

          6. 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.

          7. Patients who stopped everolimus treatment was less than 4 weeks prior to
             randomization.

          8. Patients with concomitant treatment with interferon.

          9. 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.

         10. 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.

         11. Treatment with potent CYP3A4 inhibitors and inducers within 7 and 12 days,
             respectively prior to study drug administration.

         12. Concomitant treatment with therapeutic doses of anticoagulants

         13. Concomitant treatment with a drug having proarrhythmic potential

         14. Unstable systemic diseases including uncontrolled hypertension or active uncontrolled
             infections.

         15. Current treatment on another clinical trial.

         16. 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.

         17. 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.

         18. Symptomatic brain metastases, spinal cord compression, or new evidence of brain or
             leptomeningeal disease.

         19. Left ventricular ejection fraction inferior or equal 50% as measured by either
             multigated acquisition scan or echocardiogram.

         20. Positive test for human immunodeficiency virus (HIV) or acquired immunodeficiency
             syndrome (AIDS) related illness.

         21. Patients with complicated, untreated lithiasis of the bile ducts

         22. 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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Pascal HAMMEL, MD, , 

Location Countries

Belgium

Location Countries

Belgium

Administrative Informations


NCT ID

NCT01731925

Organization ID

SUNLAND D12-01

Secondary IDs

2012-001098-94

Responsible Party

Sponsor

Study Sponsor

GERCOR - Multidisciplinary Oncology Cooperative Group

Collaborators

 Pfizer

Study Sponsor

Pascal HAMMEL, MD, Principal Investigator, Hôpital Beaujon


Verification Date

January 2017