Second-line Therapy for Patients With Progressive Poorly Differentiated Extra-pulmonary Neuroendocrine Carcinoma — NET02

Oncology Clinical Trial

Official title:
A Multi-centre, Randomised, Parallel Group, Open-label, Phase II, Single-stage Selection Trial of Liposomal Irinotecan (Nal-IRI) and 5-fluorouracil (5-FU)/Folinic Acid or Docetaxel as Second-line Therapy in Patients With Progressive Poorly Differentiated Extra-pulmonary Neuroendocrine Carcinoma (NEC))

Status Active, not recruiting

Clinical Trial Summary

There is currently no standard treatment beyond first-line etoposide/platinum-based chemotherapy in patients with progressive poorly differentiated extra-pulmonary neuroendocrine carcinoma. Therefore the treatment of patients whose disease progresses on or after this first-line treatment is an area of unmet need. Combination regimens such as irinotecan/5-fluorouracil/folinic acid are a second-line treatment option currently used in Europe and world-wide for this subset of patients. However, there is currently no trial evidence supporting this treatment regimen in these patients. Results of the NAPOLI-1 phase III trial of liposomal irinotecan in the treatment of patients with metastatic pancreatic adenocarcinoma after gemcitabine-based therapy reported improved survival for those patients who received a combination of liposomal irinotecan with 5-FU/folinic acid compared to those patients who received 5-FU/folinic acid alone. Liposomal irinotecan has been found to show an improved distribution into tumour tissue in comparison to irinotecan, and this may have clinical benefit in patients with extra-pulmonary neuroendocrine carcinoma. Docetaxel is standardly used as a second-line treatment option in patients with small cell lung cancer who have progressed on primary etoposide-platinum combination therapy. Therefore this drug could also have clinical benefit in patients with extra-pulmonary neuroendocrine carcinoma as the biology of the disease is similar to small cell lung cancer. The overall aim of the NET-02 trial is to select a treatment for continuation to a Phase III trial. The intention of the trial is to determine whether liposomal irinotecan/5-fluorouracil/folinic acid and docetaxel are sufficiently active in this population of patients. If both treatments are found to be efficacious, selection criteria will be applied to select a treatment to take forward. 102 eligible participants will be randomised to receive either liposomal irinotecan/5-fluorouracil/folinic acid given every 14 days, or docetaxel given every 21 days. Participants will be treated for a minimum of 6 months or until discontinuation of treatment as per protocol.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03837977
Study type	Interventional
Source	The Christie NHS Foundation Trust
Contact
Status	Active, not recruiting
Phase	Phase 2
Start date	November 13, 2018
Completion date	December 1, 2023

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT01439152` - Phase I Study to Determine the Maximum Tolerable Dose of BAY94-9343 in Patients With Advanced Solid Tumors.	Phase 1
Recruiting	`NCT05615246` - Exactech Humeral Reconstruction Prosthesis of Shoulder Arthroplasty PMCF (HRP)
Active, not recruiting	`NCT06015009` - Symptom Management App for Children at the Early Stage of Cancer Survivorship and Their Caregivers	N/A
Active, not recruiting	`NCT03298100` - Risk Scoring Model for Endometrial Cancer
Recruiting	`NCT05055609` - Open-Label, Dose-Escalation With Expansion to Assess the Safety, Tolerability, and PK of TRE-515 in Subjects With Solid Tumors	Phase 1
Not yet recruiting	`NCT04324320` - Psychological Distress in Outpatient Oncological Rehabilitation
Completed	`NCT00588289` - Long Term Follow-Up of Patients on Children's Cancer Group Protocols- (CCG-LTF1) FOLLOW-UP DATA	N/A
Recruiting	`NCT06222801` - The 1st Tumor CytokinoTherapy Database (TCTD-1)
Recruiting	`NCT03831633` - Comparative Effectiveness of AKYNZEO® and Standard of Care (Including EMEND®) for the Prevention of Nausea and Vomiting (CINV) in Cancer Patients	Phase 4
Completed	`NCT04914702` - Feasibility and Comparison of Continuously Monitored Vital Signs in Pediatric Patients With Cancer.
Recruiting	`NCT05198570` - Pharmacokinetics of Intravenous Acyclovir in Oncologic Paediatric Patients
Recruiting	`NCT05712174` - A Study of [18]F-PSMA-1007 in Patients With Known or Suspected Metastatic Prostate Cancer	Phase 2
Recruiting	`NCT03832062` - Value of Analysing Under-utilised Leftover Tissue (VauLT)
Completed	`NCT03988777` - Magnetic Seed Localisation for Nonpalpable Breast Lesions
Recruiting	`NCT06031233` - Evaluating the Safety of Shortened Infusion Times for dIfferent Oncological Immunotherapie	Phase 4
Enrolling by invitation	`NCT04019119` - Digital Intervention for the Modification of Lifestyles (iGame)	N/A
Not yet recruiting	`NCT05926362` - Capillary-Venous Paired Data Collection
Recruiting	`NCT05686213` - ExeNTrO: Exercise During Neoadjuvant Chemoradiation Treatment to Improve Rectal and Esophageal Cancer Outcome - Pilot Trial	Phase 2
Recruiting	`NCT05510856` - Comparative Clinical Study Evaluating the Possible Efficacy of Duloxetine, Gabapentin and Lacosamide on Oxaliplatin-Induced Peripheral Neuropathy in Cancer Patients	Phase 4
Completed	`NCT04933604` - LPN in Patients With High-complex Renal Tumors