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Trial record 35 of 1309 for:    survival | Neuroendocrine Tumors

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

Tracking Information
First Submitted Date  ICMJE September 30, 2013
First Posted Date  ICMJE August 14, 2018
Last Update Posted Date August 14, 2018
Study Start Date  ICMJE December 2012
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 9, 2018)
Incidence of treatment related adverse events [ Time Frame: "3 years" ]
Establish safety profile of the combination of everolimus and intravenous radiolabeled Lu-177 DOTATATE
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 9, 2018)
Survival assessment [ Time Frame: 3 years ]
Progression free survival (PFS) and Overall survival (OS)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment of Neuroendocrine Tumors (NETs) With Combination of Everolimus and Radiolabeled Somatostatin Analogue
Official Title  ICMJE Treatment of Neuroendocrine Tumors (NETs) With Combination of Everolimus and Radiolabeled Somatostatin Analogue
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Neuroendocrine Tumors
Intervention  ICMJE Drug: Everolimus
Drug: Everolimus will be administrated in combination with the intravenous radiolabelled Lu-177 DOTATATE therapy.
Other Name: Radiolabeled Lu-177 DOTATATE
Study Arms  ICMJE Experimental: Everolimus & Radiolabeled Lu-177
Drug: Everolimus will be administrated in combination with the intravenous radiolabelled Lu-177 DOTATATE therapy.
Intervention: Drug: Everolimus
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 9, 2018)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2018
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ali Aljubran, MD 966-11-4647272 ext 32084 ajubran@kfshrc.edu.sa
Contact: Shouki Bazarbashi, MD 966-11-4423799 bazarbashi@kfshrc.edu.sa
Listed Location Countries  ICMJE Saudi Arabia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03629847
Other Study ID Numbers  ICMJE 2121-159
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party King Faisal Specialist Hospital & Research Center
Study Sponsor  ICMJE King Faisal Specialist Hospital & Research Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ali Aljubran, MD KFSH&RC
Study Director: Fazal Hussain, MD KFSH&RC
PRS Account King Faisal Specialist Hospital & Research Center
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP