Randomized Phase III of PRRT Versus Interferon

NCT01860742 | Withdrawn Phase 3

• 2 other identifiers: IJBMNCASTOR2012-005545-20
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to assess the benefit of 177Lu-DOTATATE versus interferon α-2b in patients with progressive, unresectable, non-pancreatic gastrointestinal neuroendocrine tumors resistant to therapy with somatostatin analogues, in terms of disease control.

Conditions

Gastro-intestinal Neuroendocrine Tumors

Keywords

Peptide Receptor Radionuclide Therapy (PRRT); Neuroendocrine Tumors; Interferon alpha

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS)

  PFS is defined by the time between treatment initiation and the first of the following events: * Disease progression according to RECIST 1.1; * Death of the patient from any cause; * Appearance of confirmed new lesion(s) on 68Ga-DOTATATE PET/CT or 18FDG PET/CT.

  3 years [Anticipated]

Secondary Outcomes (3)

• Treatment response according to RECIST 1.1 (Response Evaluation Criteria In Solid Tumors)

  3 years [Anticipated]

• Adverse events according to Common Terminology Criteria for Adverse Events version 4.03 (CTC 4.03-WHO criteria)

  3 years [Anticipated]

• Tumor 18FDG PET/CT and 68Ga-octreotate PET/CT uptake at baseline, at mid and end of treatment

  3 years [Anticipated]

Study Arms (2)

Interferon alpha-2b

ACTIVE COMPARATOR

Interferon α-2b in a dose of 5000000 Units administered subcutaneously every second day until progression or unacceptable adverse event from a clinical or a patient point of view.

Drug: Interferon alpha-2b

177Lu-DOTATATE

ACTIVE COMPARATOR

intravenous injection of 177Lu-octreotate with simultaneous infusion of an aminoacid solution

Drug: 177Lu-DOTATATE

Interventions

Interferon alpha-2b DRUG

Interferon α-2b in a dose of 5000000 Units administered subcutaneously every second day

Also known as: Intron A

Interferon alpha-2b

177Lu-DOTATATE DRUG

177Lu-octreotate infusions in fixed activities of 7,4 GigaBecqurel each, given 8-11 weeks apart, injected intravenously with simultaneous infusion of an amino acid solution

Also known as: 177Lu-octreotate, Lutate

177Lu-DOTATATE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (≥ 18 yrs).
• Histology-proven non-pancreatic gastrointestinal NETs.
• Disease progression under SSAs (SSAs-resistant disease). Disease progression must be documented with at least one of the following:
• Radiological disease progression (according to RECIST 1.1) on an MRI or CT over the last 12 months.
• Disease progression on a somatostatin receptor-imaging (PET/CT or SPECT/CT) over the last 12 months (apparition of new lesion(s) or increase in the transaxial plane diameter of more than 30% on the same imaging modality).
• There should be at least one target lesion. A target lesion should fulfill all the following criteria:
• Uptake higher than the physiological liver uptake on the baseline 68Ga-DOTATATE PET/CT
• Longest transaxial plane diameter ≥ 20mm measured on the CT or MRI;
• Not previously irradiated.
• Long-acting SSAs must be discontinued at least 4 weeks before the study treatment start date and, if needed, switched to short-acting analogues which must be stopped 48h before the treatment date.
• Adequate renal function with GFR ≥ 50 mL/min/1.73m2 (evaluated by 51Cr-EDTA test).
• Adequate bone marrow function with:
• Hemoglobin ≥ 9 g/dL;
• Neutrophil ≥ 1.5·109/L;
• Platelet count ≥ 100·109/L.

You may not qualify if:

• Resectable tumor with curative intent.
• Previous PRRT or MIBG treatment.
• Presence of non-benign 18FDG-positive lesions (higher than 2 x normal liver (or thoracic aorta uptake -SUVmax- in case of liver involvement)) without significant 68Ga-DOTATATE uptake.
• Uncontrolled congestive heart failure (NYHA stade ≥ 2).
• Diffuse bone marrow infiltration on the baseline 68Ga-DOTATATE PET/CT confirmed by MRI.
• Prior external beam radiotherapy on kidneys or on more than 25% of bone marrow.
• Patients with known uncontrolled brain metastases.
• History of other active malignant disease or clinical remission less than 5 years (except in case of non melanoma skin cancer or in situ cervical carcinoma).
• Known autoimmune hepatitis.
• Patients after organ transplantation under immunosuppressive therapy.
• Patients with a significant medical, neuro-psychiatric, or surgical condition, currently uncontrolled by treatment, which, in the investigator's opinion, may interfere with completion of the study.
• Hypersensitivity to interferon α-2b or to any component of the product.
• Pregnant or lactating patients.

Sponsors & Collaborators

• Jules Bordet Institute: lead

Study Sites (2)

Jules Bordet Institute

Brussels, B-1000, Belgium

Location

UZ Leuven

Leuven, B-3000, Belgium

Location

MeSH Terms

Conditions

Neuroendocrine Tumors

Interventions

Introns; lutetium Lu 177 dotatate; 177Lu-octreotate

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

DNA, Intergenic; Genome Components; Genome; Genetic Structures; Genetic Phenomena; Gene Components; Genes

Study Officials

• Patrick Flamen, M.D., Ph.D.

  Jules Bordet Institute

  PRINCIPAL INVESTIGATOR

• Christophe Deroose, M.D., Ph.D.

  UZ Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2013
• First Posted: May 23, 2013
• Study Start: December 1, 2014
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: April 5, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (2)