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Treatment of Neuroendocrine Tumors (NETs) With Combination of Everolimus and Radiolabeled Somatostatin Analogue

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ClinicalTrials.gov Identifier: NCT03629847
Recruitment Status : Recruiting
First Posted : August 14, 2018
Last Update Posted : August 14, 2018
Sponsor:
Information provided by (Responsible Party):
King Faisal Specialist Hospital & Research Center

Brief Summary:
NET originate in neuroendocrine cells throughout the body. The goal of this study is to assess the safety and efficacy of the combination of everolimus and the intravenous radiolabeled Lu-177 DOTATATE Therapy as a 1st line therapy in unresectable well to moderately differentiated metastatic neuroendocrine tumors of all GI, lung and pancreatic origins. This is a phase 1 - 2 study. The phase 1 part involves finding the maximum tolerating dose (MTD) of Everolimus.

Condition or disease Intervention/treatment Phase
Neuroendocrine Tumors Drug: Everolimus Phase 1 Phase 2

Detailed Description:
Neuroendocrine tumors NET refers to tumors that originate in neuroendocrine cells throughout the body (including in the thymus, lung, pancreas, gastrointestinal [GI] tract and less common sites). They can be broadly subclassified into well-differentiated and poorly differentiated cancers. Treatment of well differentiated NET are complex and involves surgical, Locoregional and systemic modalities depending on the manifestations as well as extent of disease. Treatment is best planned in a multidisciplinary tumor board. Of the emerging new systemic modalities are Everolimus and radiolabelled somatostatin analogue. The goal of this study is to assess the safety and efficacy of the combination of everolimus and the intravenous radiolabeled Lu-177 DOTATATE Therapy (a somatostatin analogue) as a first line therapy in unresectable well to moderately differentiated metastatic neuroendocrine tumors of all gastrointestinal, lung and pancreatic origins. This is a phase 1 - 2 study. The phase 1 part involves finding the maximum tolerating dose (MTD) of Everolimus.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Neuroendocrine Tumors (NETs) With Combination of Everolimus and Radiolabeled Somatostatin Analogue
Study Start Date : December 2012
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018


Arm Intervention/treatment
Experimental: Everolimus & Radiolabeled Lu-177
Drug: Everolimus will be administrated in combination with the intravenous radiolabelled Lu-177 DOTATATE therapy.
Drug: Everolimus
Drug: Everolimus will be administrated in combination with the intravenous radiolabelled Lu-177 DOTATATE therapy.
Other Name: Radiolabeled Lu-177 DOTATATE




Primary Outcome Measures :
  1. Incidence of treatment related adverse events [ Time Frame: "3 years" ]
    Establish safety profile of the combination of everolimus and intravenous radiolabeled Lu-177 DOTATATE


Secondary Outcome Measures :
  1. Survival assessment [ Time Frame: 3 years ]
    Progression free survival (PFS) and Overall survival (OS)



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 18 years old.
  • Histologically confirmed well to moderately differentiated neuroendocrine tumors of GI, lung or pancreatic origin. The grading follows the WHO grading system (Appendix III).
  • Measurable disease by CT or MRI.
  • Positive Tc-99m Octreotide scan or Ga-68 Octreotate scan (Positive means uptake at tumor sites).
  • Advanced disease which are not treatable by surgical resection.
  • Documented progressive disease within the past 12 months.
  • WHO Performance Status 0 - 2.
  • Fasting blood sugar ≤ 1.5 Χ Upper Limit of Normal (ULN).
  • Fasting triglycerides ≤ 2.5 Χ Upper Limit of Normal (ULN), and fasting cholesterol ≤ 300 mg/dl or ≤ 7.75 ml/l.
  • Adequate renal function with creatinine clearance ≥ 60 ml/l.
  • Adequate hepatic function:
  • Total bilirubin ≤ 1.5 Χ Upper Limit of Normal (ULN)
  • Liver Function Tests (Serum aspartate aminotransferase and alanine transaminase levels) ≤ 2.5 Χ ULN (and ≤ 5 Χ ULN, in case of presence of liver metastasis)
  • Adequate hematological values:
  • Absolute neutrophil count ≥ 1 x 109/L
  • Platelet count ≥ 100 x 109/L
  • Signed written informed consent before enrolment.

Exclusion Criteria:

  • Readily completely Resectable disease.
  • Prior therapy with everolimus or systemic chemotherapy.
  • Prior chemoembolization, radio-embolization, or bland embolization within 6 months before enrolment. Likewise, patients are ineligible if had undergone conventional radiotherapy, radiofrequency ablation, cryoablation or alcohol injection within 1 month prior to enrolment.
  • Prior long acting somatostatin analogue within 1 month prior to enrolment. Short acting somatostatin analogue is allowed as long as it is not administered within 12 hours before or /and 12 hours after the administration of the intravenous radiolabelled Lu-177 DOTATATE Therapy.
  • Presence of Central Nervous System metastasis.
  • Previous malignancy within 5 years, except adequately treated non melanomatous skin cancer or in situ cervical cancer
  • Other active malignancy.
  • HIV infection.
  • Severe or uncontrolled medical conditions, such as:
  • Active uncontrolled severe infection
  • History of invasive fungal infection.
  • Child C liver dysfunction.
  • Severely impaired lung function.
  • Psychiatric or mental disorder, precluding understanding of the information of the trial related topics and giving valid informed consent.
  • Any psychological, familial, geographic or social circumstances which could impair the patient's ability to participate in the trial and comply with follow up.
  • Treatment with other anti-cancer therapy.
  • Known hypersensitivity to any of the study drugs.
  • Pregnant or breast feeding women.

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): NCT03629847


Contacts
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Contact: Ali Aljubran, MD 966-11-4647272 ext 32084 ajubran@kfshrc.edu.sa
Contact: Shouki Bazarbashi, MD 966-11-4423799 bazarbashi@kfshrc.edu.sa

Locations
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Saudi Arabia
Oncology Centre, King Faisal Specialist Hospital & Research Center Recruiting
Riyadh, Saudi Arabia, 11211
Contact: Ali Aljubran, MD    966-1-4647272 ext 32084    ajubran@kfshrc.edu.sa   
Contact: Lani Cabangon, RN    966-1-4647272 ext 32089    lcabangon06@kfshrc.edu.sa   
Sub-Investigator: Hussein Raef         
Sub-Investigator: Nora Alkahtani, MD         
Sub-Investigator: Shouki Bazarbashi, MD         
Sub-Investigator: Ahmed Alzahrani, MD         
Sub-Investigator: Mohamed Alsubayel, MD         
Sub-Investigator: Monther Kabbani, MD         
Sub-Investigator: Hamad Albahli, MD         
Sub-Investigator: Hadeel Almana, MD         
Sponsors and Collaborators
King Faisal Specialist Hospital & Research Center
Investigators
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Principal Investigator: Ali Aljubran, MD KFSH&RC
Study Director: Fazal Hussain, MD KFSH&RC

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Responsible Party: King Faisal Specialist Hospital & Research Center
ClinicalTrials.gov Identifier: NCT03629847     History of Changes
Other Study ID Numbers: 2121-159
First Posted: August 14, 2018    Key Record Dates
Last Update Posted: August 14, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by King Faisal Specialist Hospital & Research Center:
NETs, MTD, Everolimus.
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Sirolimus
Everolimus
Somatostatin
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists