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

NCT ID: NCT03629847

Last Updated: 2018-08-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2018-12-31

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.

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.

Conditions

Neuroendocrine Tumors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Everolimus & Radiolabeled Lu-177

Drug: Everolimus will be administrated in combination with the intravenous radiolabelled Lu-177 DOTATATE therapy.

Group Type: EXPERIMENTAL

Everolimus

Intervention Type: DRUG

Drug: Everolimus will be administrated in combination with the intravenous radiolabelled Lu-177 DOTATATE therapy.

Interventions

Everolimus

Drug: Everolimus will be administrated in combination with the intravenous radiolabelled Lu-177 DOTATATE therapy.

Intervention Type: DRUG

Other Intervention Names

Radiolabeled Lu-177 DOTATATE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

King Faisal Specialist Hospital & Research Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ali Aljubran, MD

Role: PRINCIPAL_INVESTIGATOR

KFSH&RC

Fazal Hussain, MD

Role: STUDY_DIRECTOR

KFSH&RC

Locations

Oncology Centre, King Faisal Specialist Hospital & Research Center

Riyadh, , Saudi Arabia

Site Status: RECRUITING

Countries

Saudi Arabia

Central Contacts

Ali Aljubran, MD

Role: CONTACT

ajubran@kfshrc.edu.sa

966-11-4647272 ext. 32084

Shouki Bazarbashi, MD

Role: CONTACT

bazarbashi@kfshrc.edu.sa

966-11-4423799

Facility Contacts

Ali Aljubran, MD

Role: primary

ajubran@kfshrc.edu.sa

966-1-4647272 ext. 32084

Lani Cabangon, RN

Role: backup

lcabangon06@kfshrc.edu.sa

966-1-4647272 ext. 32089

Other Identifiers

2121-159

Identifier Type: -

Identifier Source: org_study_id