Everolimus After (Chemo)Embolization for Liver Metastases From Digestive Endocrine Tumors
Overview[ - collapse ][ - ]
Purpose | Determine wether 24 months treatment with everolimus prolongs progression free survival rate (based on a central assessment) after embolisation ou chemoembolisation for liver metastases. - H0 a 24 months progression free survival rate less than 35% is unacceptable - H1 a 24 months progression free survival rate greater than 35% would show that everolimus treatment is beneficial, the expected 24 months progression free survival rate being 50% |
---|---|
Condition | Neuroendocrine Tumors Hepatic Metastases Metastases |
Intervention | Drug: Everolimus Device: embolization Drug: Doxorubicin |
Phase | Phase 2 |
Sponsor | Federation Francophone de Cancerologie Digestive |
Responsible Party | Federation Francophone de Cancerologie Digestive |
ClinicalTrials.gov Identifier | NCT01678664 |
First Received | August 22, 2012 |
Last Updated | January 2, 2013 |
Last verified | January 2013 |
Tracking Information[ + expand ][ + ]
First Received Date | August 22, 2012 |
---|---|
Last Updated Date | January 2, 2013 |
Start Date | October 2012 |
Estimated Primary Completion Date | April 2017 |
Current Primary Outcome Measures | Rate of hepatic progression free survival at 24 months [Time Frame: 24 months after the last included patient] [Designated as safety issue: No]Hepatic progression free survival rate as defined in RECIST 1.1 (with death considered as progression) during the 24 months of treatment with everolimus (appendix 3). Progression-free survival rate (PFS) (based on the central assessment) according to RECIST v1.1 according to RECIST v1.1 will be defined as the time from the date of inclusion to the date of hepatic progression or death (due to any cause). For patients who are alive with no hepatic progression, it will be defines as the time from the date of inclusion and the date of the last tumor assessment. |
Current Secondary Outcome Measures |
|
Descriptive Information[ + expand ][ + ]
Brief Title | Everolimus After (Chemo)Embolization for Liver Metastases From Digestive Endocrine Tumors |
---|---|
Official Title | Everolimus as Treatment After Embolization or Chemoembolization for Liver Metastases From Digestive Endocrine Tumors |
Brief Summary | Determine wether 24 months treatment with everolimus prolongs progression free survival rate (based on a central assessment) after embolisation ou chemoembolisation for liver metastases. - H0 a 24 months progression free survival rate less than 35% is unacceptable - H1 a 24 months progression free survival rate greater than 35% would show that everolimus treatment is beneficial, the expected 24 months progression free survival rate being 50% |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 2 |
Study Design | Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment |
Condition |
|
Intervention | Drug: Everolimus 10 mg per day of everolimus during 24 months or until progression disease Device: embolization 2 sessions embolization with spheric particles Other Names: spheric particules of 100 to 500 µmDrug: Doxorubicin 2 sessions chemoembolization with 10 mg of lipiodol with 100 mg of doxorubicine Other Names: Chemoembolization |
Study Arm (s) | Experimental: embolization or chemoembolization plus everolimus After 2 sessions of embolization with microsphere of 100 to 500 µm or chemoembolization with 100 mg of doxorubicine and 10 ml of lipiodol, administered every day, 10 mg of everolimus during 24 months or until progression (hepatic and other site). |
Recruitment Information[ + expand ][ + ]
Recruitment Status | Recruiting |
---|---|
Estimated Enrollment | 72 |
Estimated Completion Date | April 2017 |
Estimated Primary Completion Date | April 2017 |
Eligibility Criteria | Inclusion Criteria: - Well differentiated (grade 1 and 2 according to WHO classification 2010 appendix 2), histologically-proven endocrine tumor of the gastrointestinal tract (TENpath review mandatory), - Measurable liver metastasis (or metastases) as defined in RECIST v1.1 that are unresectable and inaccessible to radiofrequency ablation-type local treatment - Hepatic arterial embolization or chemoembolization indicated for tumor size reduction, confirmed in an multidisciplinary team (MDT) meeting, due to the progressive nature of the liver metastases (morphological progression during the past 12 months as defined in RECIST v1.1) - Age ≥ 18 years - WHO performance status ≤ 2 - No contraindications to embolization or chemoembolization or everolimus - Satisfactory laboratory assessments:Neutrophil count ≥ 1.5 x 109/L, platelet count ≥ 100 x 109/L, Hb > 10 g/dL, serum bilirubin ≤ 1.5 x the upper limit of normal (ULN), INR < 1.3 (or < 3 for patients on anticoagulant therapy) ALT and AST ≤ 5 x ULN, creatinine ≤ 1.5 x ULN, fasting serum cholesterol ≤ 300 mg/dL or 7.75 mmol/L and triglycerides ≤ 2.5 x ULN (if either or both of these limits are exceeded, the patient may only be included into the study after institution of appropriate lipid-lowering therapy) - Complete resolution of toxic effects of any prior treatments, or persistence at grade 1 at most (CTCAE version 4.0) - Minimum time since previous treatment: 28 days - Patient has been informed and has signed an informed consent form, after verification of the eligibility criteria - Patient covered by a French national health insurance scheme Exclusion Criteria: - Duodenopancreatic neuroendocrine tumor - Poorly differentiated and/or grade 3 endocrine tumor, - Embolization or chemoembolization indicated for symptomatic control only - Prior hepatic TACE or embolization - Prior treatment with an mTOR inhibitor (somatostatin analogs to control secretion are permitted) - Symptomatic bone metastasis (or metastases) - Any uncontrolled progressive disease: hepatic failure, renal failure, respiratory failure, NYHA class III-IV congestive heart failure, unstable angina, myocardial infarction, significant arrhythmia - Interstitial lung disease - Uncontrolled diabetes, defined by HbA1c > 8% - Chronic corticosteroid or immunosuppressant therapy - Hypersensitivity to everolimus, other rapamycin derivatives, or one of the excipients - Major surgery, open biopsy, or significant traumatic lesion during the 28 days prior to starting the investigational treatment Incompletely healed wound or foreseeable need for major surgery during the study - Contraindication to vascular occlusion procedures: Portal thrombosis, biliodigestive anastomosis - Malignancy during the past 5 years, with the exception of curatively treated basal cell skin carcinoma or in situ cervical cancer - Foreseeable non-compliance - Medical, geographic, sociological, psychological, or legal situation that would preclude the patient from completing the study or signing an informed consent form - Pregnant or breast-feeding women - Men or women of child-bearing potential not using effective contraception - Concurrent participation in another investigational study that could affect the primary endpoint of this study |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Contact: Emmanuel MITRY, PhD +33 (0)1 47 11 15 29 emmanuel.mitry@curie.net |
Location Countries | France |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01678664 |
---|---|
Other Study ID Numbers | FFCD 1104 |
Has Data Monitoring Committee | Yes |
Information Provided By | Federation Francophone de Cancerologie Digestive |
Study Sponsor | Federation Francophone de Cancerologie Digestive |
Collaborators | Not Provided |
Investigators | Principal Investigator: Emmanuel MITRY, PhD Institut Curie |
Verification Date | January 2013 |
Locations[ + expand ][ + ]
Fédération Francophone de Cancérologie Digestive | Dijon, Côte d'Or, France, 21000 Contact: Marie MOREAU | +33 (0)3 80 39 34 04 | marie.moreau@u-bourgogne.frSub-Investigator: Come LEPAGE, PhD Recruiting |
---|