Assessment of the Efficacy of Bevacizumab in Combination With Folfiri as Second-line Treatment in Patients Suffering From an Advanced Inoperable Poorly Differentiated Neuroendocrine Carcinoma of an Unknown or Gastroentero-pancreatic Primary Cancer

Sponsor
Hospices Civils de Lyon
Study ID
NCT02820857
Phase
PHASE2
Status
Completed

Conditions

  • Neuroendocrine Carcinomas

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Folfiri-bevacizumab — DRUG
    Patient treated with a combination Folfiri-bevacizumab. Treatment every 2 weeks (D1 = D15)
  • Folfiri — DRUG
    Patient treated with Folfiri only. Treatment every 2 weeks (D1 = D15)

Study Details

Poorly differentiated neuroendocrine carcinomas (NEC) are a sub-group of aggressive neuroendocrine neoplasms (NEN). The most common primary sites are broncho-pulmonary and digestive. The gastroentero-pancreatic NECs (GEP-NEC) represent 7-21% of all of the NENs. Recent data on the initial presentation of GEP-NEC have been reported in two retrospective studies and a French cohort study. No standard second-line treatment has been defined for NECs. Despite a very negative prognosis, these NECs have a certain amount of chemosensitivity, close to that of bronchial NECs. Multiple-drug therapies such as Folfiri, or Folfox, or single drug treatments such as temozolomide are the proposed options but with a low level of proof Bevacizumab associated with a cytotoxic chemotherapy has shown promising results in well differentiated neuroendocrine tumors (NET), known for being hypervascular. The efficacy of bevacizumab has also been suggested in patients with NEC, but never in the context of a phase II study. Its combination with Folfiri is efficient and well tolerated in metastatic colorectal cancer. The combination Folfiri-bevacizumab potentially represents an optimized treatment compared to chemotherapy with only Folfiri. No phase II or III studies have reported results for these patients, and no on-going phase II or III trial have been identified to date. The main objective of this study is to show that, after the failure of a first-line chemotherapy using platinum-etoposide, the combination Folfiri-bevacizumab allows significant prolongation of overall survival in adult patients with GEP-NEC.

Key Dates

First listed
Jul 1, 2016
Start date
Sep 4, 2017
Status verified
Aug 2025
Primary completion
Aug 8, 2022
Completion
Aug 24, 2024

Study Design

Enrollment
153 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Folfiri-bevacizumab
    Patient treated with a combination Folfiri-bevacizumab. Treatment every 2 weeks (D1 = D15)
  • Active Comparator: Folfiri
    Patient treated with Folfiri only. Treatment every 2 weeks (D1 = D15)

Primary Outcome Measure

Proportion of patients alive [ Time Frame: 6 months after treatment ]

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