Status:
RECRUITING
Chemotherapy For Metastatic Grade 3 Poorly Differentiated NEuroendocrine Carcinoma Of GastroEnteroPancreatic And Unknown Primary
Lead Sponsor:
Centre Hospitalier Universitaire Dijon
Collaborating Sponsors:
National Cancer Institute, France
Conditions:
Neuroendocrine Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
there is a need for improving chemotherapy regimen for metastatic G3 NEC of GEP and Unknown origin and this goal may be achieved through more "personalized" chemotherapy regimen.the hypothesis is that...
Detailed Description
Grade 3 poorly differentiated neuroendocrine carcinomas (G3 NEC) are rare diseases. The diagnosis is often done at the metastatic stage and the prognosis is poor. The standard first-line treatment is ...
Eligibility Criteria
Inclusion
- Grade 3 neuroendocrine carcinoma or high grade MiNEN with a grade 3 poorly differentiated neuroendocrine carcinoma component ≥30% of gastro-entero-pancreatic or unknown primary
- Poorly differentiated
- Small cell or large cell or non-small cell or non- typeable
- Metastatic disease
- First-line, no prior therapy for metastatic disease, no prior use of carboplatin, oxaliplatin, cisplatin, etoposide, irinotecan and 5-fluorouracile
- At least one measurable lesion as assessed by CT-scan or MRI according to RECIST 1.1 guidelines
- Available tumor block
- ANC ≥ 1.5x109/l, platelet ≥ 100x109/l and hemoglobin \> 8 g/dl
- Total bilirubin ≤ 1.5N, AST ≤ 2.5N, ALT≤ 2.5N or AST/ALT ≤ 5N in case of liver metastases.
- Age ≥ 18 years
- ECOG Performance Status ≤ 1
- Signed and dated informed consent, and willing and able to comply with protocol requirements.
- Women of childbearing potential, as well as men (who have sexual relations with women of childbearing potential) must agree to use an effective method of contraception throughout this study and during the 15 months following administration of the last dose of the study medicinal product
- Patient who is a beneficiary of the Social security system
Exclusion
- Grade 3 well differentiated neuroendocrine tumor according to WHO 2017 classification
- Severe renal impairment (creatinine clearance less than 30 mL/min, MDRD)
- Partial or complete Dihydropyrimidine Dehydrogenase (DPD) deficiency (uracilemia ≥ 16 ng/mL)
- Gilbert's syndrome
- Pre-existing permanent neuropathy (NCI CTC V4.0 grade ≥2)
- Previously treated by chemotherapy or targeted therapy
- Brain metastases unless they are asymptomatic or under stable corticosteroid doses for 2 weeks otherwise. Radiation therapy prior to inclusion is required if symptomatic.
- Combination with sorivudine and others analogues as brivudine (irreversibly inhibits the enzyme dihydropyrimidine dehydrogenase)
- Treatment with St John's Wort (Hypericum perforatum)
- Pregnant women or breastfeeding mother
- Known or historical active infection with HIV, or known active infection untreated with hepatitis B or hepatitis C
- History of prior malignancy, except for cured non-melanoma skin cancer, cured in situ cervical carcinoma, or other treated malignancies with no evidence of disease for at least three years.
- Active or suspected acute or chronic uncontrolled disease that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, or which, in the judgment of the investigator, would make the patient inappropriate for entry into this study
- vaccinations (live vaccine) within 30 days prior to start of study drugs
- Patient under guardianship and/or deprived of his/her freedom
- QT/QTc interval \> 450 msec for male and \> 470 msec for female at EKC.
- K+ \< LLN, Mg²+ \< LLN, Ca²+ \< LLN
- History or know hypersensitivity to any of the study chemotherapy agents, or their excipients
Key Trial Info
Start Date :
September 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2029
Estimated Enrollment :
218 Patients enrolled
Trial Details
Trial ID
NCT04325425
Start Date
September 1 2020
End Date
September 1 2029
Last Update
September 30 2025
Active Locations (6)
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1
Chu de Caen
Caen, France, 14033
2
Chu Dijon Bourgogne
Dijon, France, 21000
3
Institut de Cancérologie de Bourgogne
Dijon, France, 21000
4
Chu de Limoges - Dupuytren
Limoges, France, 87042