Progressive advanced/metastatic midgut carcinoid tumors MedDRA version: 15.0 Level: LLT Classification code 10068118 Term: Metastatic carcinoid tumor System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Sutent
Product Name: Sunitinib
Pharmaceutical Form: Capsule, hard
CAS Number: 341031-54-7
Other descriptive name: SUNITINIB MALATE
Concentration unit: mg milligram(s)
Concentration type: e
Sponsors
GERCOR
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: * Patients with midgut well-differentiated Grade 1-2 endocrine tumor (ENETS guidelines). Pathological confirmation might have been obtained from primary tumor (surgical resection), or lymph node/liver metastases. Histologically documented endocrine liver metastases with unknown primary are eligible if the patient has history of carcinoid syndrome with elevated serum chromogranin A and urinary 5HIAA levels. * 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. The previous scans will be used to classify the patient as having progressive disease at baseline according to RECIST v1.1 criteria. Octreoscan results may be used to document progressive disease at baseline, but not for RECIST v1.1 determination during the study. Locally advanced liver metastasis, corresponding to >50% liver involvement as documented on baseline CT-scan or MRI by the local investigator, are eligible regardless prior progression * Chromogranin A and 5HIAA levels >1.5ULN as measured in each individual centre * Disease that is not amenable to surgery with curative intent * ECOG Performance status 0 or 1 * Age more than 18 years * Able to swallow oral compound Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 73 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 31
Exclusion criteria
Exclusion criteria: * Patients with undifferentiated, poorly differentiated gastrointestinal neuroendocrine tumors, pancreatic neuroendocrine tumors, bronchial carcinoid tumors (WHO 2010 classification) * 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 other than somatostatin analogues * Prior treatment with any tyrosine kinase inhibitors or anti-VEGF angiogenic inhibitors (such as bevacizumab, sorafenib, or sunitinib). Prior treatment with non-VEGF-targeted angiogenic inhibitors such as everolimus or temsirolimus is permitted * Patients who stopped everolimus treatment was less than 4 weeks prior to randomization * Patients with concomitant treatment with interferon * Concomitant treatment with a drug having proarrhythmic potential (terfenadine, quinidine, procainamide, disopyramide, sotalol, probucol, bepridil, haloperidol, risperidone, indapamide and flecainide) * Unstable systemic diseases including uncontrolled hypertension (>150/100 mmHg despite optimal medical therapy) or active uncontrolled infections * Ongoing cardiac dysrhythmias of NCI CTC grade ?2, atrial fibrillation of any grade, or prolongation of the QTc interval to >450 msec for males or >470 msec for females
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of the combination of sunitinib with lanreotide and of placebo with lanreotide regarding progression-free-survival (PFS) as assessed by local investigators;Secondary Objective: To evaluate overall survival (OS) in sunitinib- and placebo-treated subjects. - To evaluate duration of response (DR) in sunitinib- and placebo-treated subjects in subjects achieving a response. - To evaluate objective response (OR) rate in sunitinib- and placebo-treated subjects. - To assess time to tumor response (TTR) for sunitinib- and placebo-treated subjects. - To assess Health related Quality of life (EORTC QLQ C-30). - To evaluate the symptomatic effects of sunitinib in subject with carcinoid syndrom. - To evaluate the best biological responses as assessed using serum chromogranin A and urine 5HIAA for sunitinib- and placebo-treated subjects. - To evaluate plasma levels of VEGF-A, VEGF-C, sKIT, and sVEGFR2 as determined by Elisa assay for sunitinib- and placebo-treated subjects, at baseline, 1-month treatment, at first tumor evaluation and at the end of study treatment (optional). - To assess safety and tolerability of sunitinib in the study population ;Primary end point(s): Progression-Free-Survival (PFS);Timepoint(s) of evaluation of this end point: Time from date of randomization to first progression of disease (PD) or death for any reason in the absence of documented PD | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Overall survival is defined as the time from date of randomization to date of death. In the absence of confirmation of death, survival time will be censored to last date the subject is known to be alive. - The objective response (OR) is the overall objective response recorded from randomization until disease progression: sustained complete response (CR) or partial response (PR) according to RECIST v1.1 definitions for at least 4 weeks, confirmed by tumor assessments. - Duration of response (DR) is defined as the time from the first documentation of objective tumor response (CR or PR) that is subsequently confirmed to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first. ;Timepoint(s) of evaluation of this end point: Overall survival :time from date of randomization to date of death. In the absence of confirmation of death, survival time will be censored to last date the subject is known to be alive. Overall objective response: recorded from randomization until disease progression Duration of response:time from the first documentation of objective tumor response | — |
Countries
France
Contacts
Public ContactHADENGUE
GERCOR
Outcome results
None listed