Pancreatic Neoplasms Clinical Trial
Official title:
Efficacy and Safety of High Dose Regimen of Octreotide LAR in Patients With Neuroendocrine Tumors in Progressive Disease: A Phase II, Open, Multicentric Prospective Study
Octreotide (OCT) is a somatostatin analogue (SSA) available in a long-acting formulation,
conventionally administered every 28 days at the maximum dose of 30 mg. Together with
lanreotide, it is considered the therapy of choice in the control of endocrine syndromes
associated with neuroendocrine tumors (NET)s. A complete or partial clinical response to SSA
therapy is generally achieved in at least 50% of the patients with neuroendocrine syndrome.
Many studies reported a clinical response in 70-90% of functioning NETs. In about 36-50% of
the patients with progressive advanced well differentiated NET (WDNET), a stabilization of
disease occurs after treatment with subcutaneous OCT. By developing long-acting slow-release
SSA formulation, long-acting OCT (LAR), lanreotide-SR, lanreotide-Autogel, the patient's
compliance to SSA therapy was improved and escape from treatment, which was common with the
subcutaneous formulation, was avoided. However, rate of objective response was not
significantly improved as compared to short-acting SSA. On the other hand, it has to be
remarked that long-acting SSA are being used in NET patients at doses correspondent to the
low doses of short-acting formulation. The higher commercially available doses of LAR is 30
mg, which is assumed to be comparable to 300 µg of short-acting OCT in the therapy of
acromegaly.
Only one study was designed to investigate the use of high-dose LAR (160 mg every 28 days).
In this study, objective and hormonal responses in patients with progressive metastatic
ileal NET non-responder to standard doses, was significantly elevated. However, this
compound has never been commercialized and, of consequence, this first preliminary
observation has not been confirmed by further studies.
No systematic studies were performed with the commercially available long-acting SSA used in
high-dose treatments. In patients with progressive locally advanced or metastatic NET,
increase of the dose or reduction of the interval between injections is a relatively common
"empirical" clinical practice, but no studies have been performed to evaluate safety and
efficacy of this treatment schedule.
The patient population will include the patients with a histologically documented diagnosis of WDNET, defined according to the last WHO Classification criteria for NET of gastro-entero-pancreatic, bronchial, thymic or other origin; and showing tumor progression under a standard dose treatment with LAR (30 mg every 28 days) for at least 6 months. Progressive disease will be defined as increased tumor size according to RECIST definitions. ;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04085055 -
Fine Needle Biopsy of Solid Pancreatic Mass Lesions
|
N/A | |
Recruiting |
NCT01950572 -
Tissue Procurement and Natural History Study of Patients With Malignant Mesothelioma
|
||
Terminated |
NCT00529113 -
Study With Gemcitabine and RTA 402 for Patients With Unresectable Pancreatic Cancer
|
Phase 1 | |
Recruiting |
NCT05351983 -
Patient-derived Organoids Drug Screen in Pancreatic Cancer
|
N/A | |
Recruiting |
NCT04809935 -
EUS-Coeliac Plexus Block Versus Radiofrequency Ablation in Pain Relief of Patients With Malignancy
|
Phase 4 | |
Recruiting |
NCT05481476 -
Surufatinib Combined With Sintilimab and AG in First-line Therapy of Patients With Locally Advanced or Metastatic Pancreatic Cancer
|
Phase 2 | |
Not yet recruiting |
NCT04652271 -
International Pancreatic Surgery Outcomes Study - PancreasGroup.Org
|
||
Active, not recruiting |
NCT02950064 -
A Study to Determine the Safety of BTP-114 for Treatment in Patients With Advanced Solid Tumors With BRCA Mutations
|
Phase 1 | |
Completed |
NCT03054987 -
Endoscopic Ultrasound and Endoscopic Retrograde Cholangiopancreatography for Malignant Distal Biliary Obstruction
|
N/A | |
Completed |
NCT02909530 -
Comparison Between Olympus EZ Shot 3Plus 19G and EZ Shot 2 19G in EUS-guided FNB of Solid Pancreatic Masses
|
N/A | |
Completed |
NCT02374411 -
Knowledge, Attitudes, and Practice of Surgeons Toward Nutrition Support in HIPEC Patients
|
N/A | |
Completed |
NCT01770405 -
Clinical Registry of nCLE in Masses and Cystic Tumors of the Pancreas, Lymph Nodes, Submucosal Lesions of the GI Tract
|
N/A | |
Terminated |
NCT01515046 -
Clinical Trial of High-dose Vitamin C for Advanced Pancreatic Cancer
|
Phase 2 | |
Terminated |
NCT01313416 -
Gemcitabine and CT-011 for Resected Pancreatic Cancer
|
Phase 2 | |
Enrolling by invitation |
NCT01465425 -
Extracolonic Findings on Computed Tomography (CT) Colonography
|
||
Terminated |
NCT01434459 -
Study of Gemcitabine With TheraSphere® (Yttrium-90)in Patients With Hepatic Tumors of Pancreatobiliary Origin
|
Phase 1 | |
Completed |
NCT00985777 -
Vitamin E δ-Tocotrienol Administered to Subjects With Resectable Pancreatic Exocrine Neoplasia
|
Phase 1 | |
Completed |
NCT00385177 -
Phase 1 Dose Escalation Study of SN2310 Injectable Emulsion in Patients With Advanced Solid Tumors
|
Phase 1 | |
Recruiting |
NCT00178763 -
Hyperthermia With Chemotherapy for Locally Advanced or Metastatic Pancreas Cancer
|
Phase 2 | |
Completed |
NCT00136669 -
Acupuncture For Pancreatic Cancer Pain
|
Phase 3 |