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Expanded Access Protocol for Therapeutic Use of 177Lu-DOTA0-Tyr3-Octreotate in Patients With Inoperable, Somatostatin Receptor Positive, Midgut Carcinoid Tumors, Progressive Under Somatostatin Analogue Therapy

Expanded access is currently available for this treatment.
Verified June 2017 by Advanced Accelerator Applications
Sponsor:
Information provided by (Responsible Party):
Advanced Accelerator Applications
ClinicalTrials.gov Identifier:
NCT02705313
First received: March 7, 2016
Last updated: June 12, 2017
Last verified: June 2017
  Purpose
Advanced Accelerator Applications is currently pursuing marketing approval for 177Lu-DOTA0-Tyr3-Octreotate (Lutathera). Considering that Phase III NETTER-1 clinical trial recruitment has been completed, this expanded access therapeutic protocol aims to allow patients suffering from inoperable, somatostatin receptor positive, midgut carcinoid tumors, progressive under somatostatin analogue therapy to access the investigational product, 177Lu-DOTA0-Tyr3-Octreotate (Lutathera), prior to its commercial availability.

Condition Intervention
Midgut Carcinoid Tumor Drug: 177Lu-DOTA0-Tyr3-Octreotate

Study Type: Expanded Access     What is Expanded Access?
Official Title: Expanded Access Protocol for Therapeutic Use of 177Lu-DOTA0-Tyr3-Octreotate in Patients With Inoperable, Somatostatin Receptor Positive, Midgut Carcinoid Tumors, Progressive Under Somatostatin Analogue Therapy

Resource links provided by NLM:


Further study details as provided by Advanced Accelerator Applications:

Intervention Details:
    Drug: 177Lu-DOTA0-Tyr3-Octreotate
    The treatment regimen consists of 4 administrations of 7.4 GBq (200 mCi) at the date and time of infusion. The recommended interval between two infusions is 8 weeks, which could be extended up to 16 weeks in case of dose modifying toxicity.
    Other Name: Lutathera
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • Presence of metastasized or locally advanced, inoperable (curative intent) at enrollment time, midgut carcinoid tumor.
  • Ki67 index ≤ 20%
  • Patients progressive under SSA (any dose) at the time of enrollment
  • Target lesions over-expressing somatostatin receptors according to an appropriate imaging method (e.g. 111In-pentetreotide (Octreoscan) imaging or 68Ga-DOTA0-Tyr3-Octreotate (or 68Ga-edotreotide) imaging)

Exclusion Criteria:

  • Either serum creatinine >150 μmol/L (>1.7 mg/dL), or creatinine clearance <50 mL/min calculated by the Cockroft Gault method, eventually confirmed by measured creatinine clearance (or measured glomerular filtration rate (GFR) using plasma clearance methods, not gamma camera-based) <50 mL/min (the measured creatinine clearance / GFR is required only as confirmatory exam).
  • Hb concentration <5.0 mmol/L (<8.0 g/dL); WBC <2x109/L (2000/mm3); platelets <75x109/L (75x103/mm3).
  • Total bilirubin >3 x ULN.
  • Serum albumin <3.0 g/dL unless prothrombin time is within the normal range.
  • Pregnancy or lactation.
  • For female patients of childbearing potential (defined as < 2 years after last menstruation and not surgically sterile) and male patients, who are not surgically sterile or with female partners of childbearing potential: absence of effective, non-hormonal means of contraception (intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal gel).
  • Any surgery, radioembolization, chemoembolization, chemotherapy and radiofrequency ablation within 12 weeks prior to enrollment.
  • Interferons, Everolimus (mTOR-inhibitors) or other systemic therapies within 4 weeks prior to enrollment.
  • Known brain metastases, unless these metastases have been treated and stabilized.
  • Uncontrolled congestive heart failure (NYHA II, III, IV).
  • Uncontrolled diabetes mellitus as defined by a fasting blood glucose >2 ULN.
  • Any patient receiving treatment with short-acting Octreotide, which cannot be interrupted for 24 h before and 24 h after the administration of 177Lu-DOTA0-Tyr3-Octreotate, or any patient receiving treatment with Octreotide LAR, which cannot be interrupted for at least 4 weeks before the administration of 177Lu-DOTA0-Tyr3-Octreotate, unless the tumor uptake on target lesions is at least as high as normal liver uptake.
  • Patients with any other significant medical, psychiatric, or surgical condition, currently uncontrolled by treatment, which may pose a risk to the patient safety
  • Prior external beam radiation therapy to more than 25% of the bone marrow.
  • Current spontaneous urinary incontinence making impossible the safe administration of the radioactive IMP.
  • Other known co-existing malignancies except non-melanoma skin cancer and carcinoma in situ of the uterine cervix, unless definitively treated and with no evidence of recurrence.
  • Patients who have not provided a signed informed consent form to accept this treatment.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02705313

Contacts
Contact: Advanced Accelerator Applications Lutathera.EAP@adacap.com

Locations
United States, Arizona
Banner M.D. Anderson Cancer Center
Gilbert, Arizona, United States, 85234
Contact: Susan Passalaqua, MD         
Contact: Boris G Naraev, MD, PhD         
United States, California
City of Hope (City of Hope Medical Center, City of Hope National Medical Center)
Duarte, California, United States, 91010
Contact: Daneng Li, MD         
University of California, Los Angeles
Los Angeles, California, United States, 90095
Contact: Martin Allen-Auerbach, MD         
University of California, San Francisco
San Francisco, California, United States, 94143
Contact: Thomas A Hope, MD         
Stanford University Medical Center
Stanford, California, United States, 94305
Contact: Erik S Mittra, MD, PhD         
United States, Colorado
University of Colorado Hospital - Anschutz Cancer Pavilion
Aurora, Colorado, United States, 80045
Contact: W. Thomas Purcell, MD         
Rocky Mountain Cancer Centers
Denver, Colorado, United States, 80218
Contact: Eric Liu, MD         
United States, Georgia
Emory University Hospital
Atlanta, Georgia, United States, 30322
Contact: Bassel El-Rayes, MD         
United States, Iowa
The University of Iowa Hospitals & Clinics (UIHC) including the Carver College of Medicine
Iowa City, Iowa, United States, 52242
Contact: David Bushnell, MD         
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Contact: Matthew H Kulke, MD         
United States, Missouri
Washington University School of Medicine Siteman Cancer Center
Saint Louis, Missouri, United States, 63110
Contact: Parag Parikh, MD         
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Contact: Dominick Lamonica, MD         
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Contact: Lale Kostakoglu, MD         
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Contact: Lisa Bodei, MD, PhD         
Montefiore Einstein Center for Cancer Care
The Bronx, New York, United States, 10467
Contact: Edward Wollin, MD         
United States, North Carolina
Duke University Hospital
Durham, North Carolina, United States, 27710
Contact: Salvador Borges-Neto, MD         
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Contact: Namrata Vijayvergia, MD         
University of Pittsburgh, Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Contact: Ashok Muthukrishnan, MD         
United States, South Carolina
Bon Secours Medical Group/ Saint Francis Hospital Cancer Center
Greenville, South Carolina, United States, 29697
Contact: Stephen Dyar, MD         
United States, Virginia
Carilion Clinic
Roanoke, Virginia, United States, 24014
Contact: Jackson Kiser, MD         
Sponsors and Collaborators
Advanced Accelerator Applications
  More Information

Responsible Party: Advanced Accelerator Applications
ClinicalTrials.gov Identifier: NCT02705313     History of Changes
Other Study ID Numbers: AAA-177Lu-03
Study First Received: March 7, 2016
Last Updated: June 12, 2017

Keywords provided by Advanced Accelerator Applications:
neuroendocrine tumor
177Lu-DOTA0-Tyr3-Octreotate

Additional relevant MeSH terms:
Carcinoid Tumor
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Somatostatin
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 27, 2017