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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01731925
• Date of registration: 19/11/2012
• Prospective Registration: Yes
• Primary sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group
• Public title: A Study of Sunitinib Versus Placebo in Combination With Lanreotide in Patients With Progressive Advanced/Metastatic Midgut Carcinoid Tumors SUNLAND
• Scientific 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
• Date of first enrolment: January 7, 2013
• Target sample size: 44
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT01731925
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 2

Countries of recruitment

Belgium, France

Contacts

• Name: Pascal HAMMEL, MD
• Affiliation: Hôpital Beaujon

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Carcinoid Tumors

Intervention(s)

Drug: Lanreotide

Drug: Sunitinib

Drug: Placebo (for sunitinib)

Primary Outcome(s)

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]

Secondary Outcome(s)

Biological responses [Time Frame: from baseline to end of treatment, assessed up to 3 years after the beginning of the study]

Safety [Time Frame: from visit 1 to 1 month after last study drug administration, assessed up to 3 years after the beginning of the study]

Objective response (OR) [Time Frame: from randomization until disease progression, assessed up to 3 years after the beginning of the study]

Duration of response (DR) [Time Frame: 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]

Quality of life [Time Frame: From screening to 1 month after last study drug administration, assessed up to 3 years after the beginning of the study]

Time to tumor response (TTR) [Time Frame: 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]

Overall survival (OS) [Time Frame: time from date of randomization to date of death, assessed up to 3 years after the beginning of the study]

Secondary ID(s)

2012-001098-94

SUNLAND D12-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ipsen

Pfizer