Second-line Therapy for Patients With Progressive Poorly Differentiated Extra-pulmonary Neuroendocrine Carcinoma
Status:
Recruiting
Trial end date:
2021-11-01
Target enrollment:
Participant gender:
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.