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Everolimus After (Chemo)Embolization for Liver Metastases From Digestive Endocrine Tumors (EVACEL)

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ClinicalTrials.gov Identifier: NCT01678664
Recruitment Status : Active, not recruiting
First Posted : September 5, 2012
Last Update Posted : June 13, 2018
Sponsor:
Information provided by (Responsible Party):
Federation Francophone de Cancerologie Digestive

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%

Condition or disease Intervention/treatment Phase
Neuroendocrine Tumors Hepatic Metastases Metastases Drug: Everolimus Device: embolization Drug: Doxorubicin Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Everolimus as Treatment After Embolization or Chemoembolization for Liver Metastases From Digestive Endocrine Tumors
Actual Study Start Date : October 2012
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : April 2019


Arm Intervention/treatment
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).
Drug: Everolimus
10 mg per day of everolimus during 24 months or until progression disease

Device: embolization
2 sessions embolization with spheric particles
Other Name: spheric particules of 100 to 500 µm

Drug: Doxorubicin
2 sessions chemoembolization with 10 mg of lipiodol with 100 mg of doxorubicine
Other Name: Chemoembolization




Primary Outcome Measures :
  1. Rate of hepatic progression free survival at 24 months [ Time Frame: 24 months ]

    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.



Secondary Outcome Measures :
  1. Progression free survival rate (hepatic or not) at 24 months [ Time Frame: 24 months ]
    Progression-free survival rate will be defined as the time from the date of inclusion to the date of disease progression (hepatic or not) evaluated by RECIST V1.1 criteria or death (due to any cause) or the date of the last morphological evaluation for patients who are alive with no disease progression.

  2. Overall survival rate [ Time Frame: 24 months ]
    Overall survival rate shall be defined as the time from the date of inclusion to the date of death, regardless of the cause of death, or the date of last contact for patients who are alive.

  3. Toxicities treatment [ Time Frame: 24 months ]
    the toxicities recorded at each monthly visit, described using -CTCAE version 4.0; grade 3 and 4 toxicities will be reviewed;



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01678664


Locations
France
CHU
Angers, France
Hôpital Avicenne
Bobigny, France
Hôpital Saint André
Bordeaux, France
Hôpital Côte de Nacre
Caen, France
CHU
Clermont Ferrand, France
Hôpital Beaujon
Clichy, France
Centre GF Leclerc
Dijon, France
CHU Bocage
Dijon, France
Hôpital Edouard Herriot
Lyon, France
CHU La Timone
Marseille, France
Hôpital Saint Joseph
Marseille, France
CHR
Orléans, France
CHU Cochin
Paris, France
Hôpital Européen Georges Pompidou
Paris, France
Hôpital Robert Debré
Reims, France
CHU
Rouen, France
Hôpital Rangueil
Toulouse, France
Hôpital Trousseau
Tours, France
Institut Gustave Roussy
Villejuif, France
Sponsors and Collaborators
Federation Francophone de Cancerologie Digestive
Investigators
Principal Investigator: Thomas WALTER, PhD Hôpital Edouard Herriot - Lyon

Responsible Party: Federation Francophone de Cancerologie Digestive
ClinicalTrials.gov Identifier: NCT01678664     History of Changes
Other Study ID Numbers: FFCD 1104
First Posted: September 5, 2012    Key Record Dates
Last Update Posted: June 13, 2018
Last Verified: June 2018

Keywords provided by Federation Francophone de Cancerologie Digestive:
cancer
neuroendocrine tumors
gastrointestinal tract
metastases
liver
hepatic

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplasms, Second Primary
Neuroendocrine Tumors
Endocrine Gland Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Neoplasms by Site
Endocrine System Diseases
Doxorubicin
Liposomal doxorubicin
Sirolimus
Everolimus
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antifungal Agents