Clinical trial · Interventional
FOLFIRINOX in Metastatic High Grade Gastroenteropancreatic Neuroendocrine Carcinomas
Phase II Trial of FOLFIRINOX in Metastatic High Grade Gastroenteropancreatic Neuroendocrine Carcinomas
NCT03042780CI-TRIAL-00048525terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow accrual
Summary
Brief summary (as posted)
The purpose of this study is evaluate the efficacy and safety of FOLFIRINOX in patients with gastroenteropancreatic high-grade neuroendocrine carcinomas. This is a prospective Phase II open-label trial, stratifying gastroenteropancreatic high grade neuroendocrine carcinomas participants equally into two cohorts (first-line versus beyond first-line).
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastro-enteropancreatic Neuroendocrine Tumor | — | UNRESOLVED | — |
| Islet Cell Carcinoma | Pancreatic Neuroendocrine Carcinoma | ALIAS | 0.90 |
| Neuroendocrine Carcinomas of Pancreas | — | UNRESOLVED | — |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FOLFIRINOX | Drug | — | UNRESOLVED |
| Granulocyte colony-stimulating factor (G-CSF) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- FOLFIRINOX Treatment
- description
- Participants will receive modified FOLFIRINOX which consists of 85 mg/m\^2 of oxaliplatin, 400 mg/m\^2 of leucovorin over the first 2 hours, 165 mg/m\^2 of irinotecan in a 90-minute infusion on day 1, followed by a continuous, 46-hour infusion of 5-FU at a dosage of 2,400 mg/m\^2. A cycle will be repeated every 14 days. Granulocyte colony-stimulating factor (G-CSF) prophylaxis will be allowed after each cycle. Participants will undergo re-staging studies every 8 weeks. Participants will receive up to 12 cycles during the study. Additional cycles will be determined per investigators' discretion.
- interventionNames
- Drug: FOLFIRINOX
- Drug: Granulocyte colony-stimulating factor (G-CSF)
Primary outcomes (1)
- measure
- Objective Radiographic Response Rate (ORR)
- timeFrame
- Up to 36 months
- description
- The primary efficacy endpoint is objective response rate as determined by radiology review, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Complete Response (CR): complete disappearance of all target lesions. Partial Response (PR): at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum longest diameter. Progressive disease (PD): at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this may include the baseline sum). Stable Disease (SD): neither sufficient decrease to qualify for partial response nor sufficient increase to qualify for progressive disease.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed neuroendocrine carcinoma of the gastrointestinal (GI) tract. Potential participants with unknown origin for the neuroendocrine carcinoma in which a gastroenteropancreatic origin is suspected (per pathologist or investigator discretion) will be eligible for the study. * Tumors must have a Ki-67 index greater than 20% and/or \>20 mitotic figures/10 high-power fields. * Must have metastatic disease. * Must measurable disease, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. * Any line of treatment (first line versus beyond first line). * Age \>18 years. * Life expectancy of greater than 12 weeks. * Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2. * Must have adequate organ and marrow function. * Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * Have had chemotherapy or radiotherapy within 3 weeks prior to entering the study. * Receiving any other investigational agents. * Untreated brain or meningeal metastases. * Prior treatment with 5-fluorouracil (5-FU), irinotecan or oxaliplatin. * Pre-treatment peripheral neuropathy greater than grade 1 per the CTCAE, version 4.0. * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * A secondary primary cancer (excluding baso/squamous cell carcinoma of skin) within 1 year. * Active viral hepatitis or autoimmune hepatitis. The work-up to confirm active hepatitis or autoimmune hepatitis will only be done if clinical suspicion based on investigator discretion. * Potential participants with childbearing potential who are not willing to use adequate contraception precautions during the study and for 3 months after stopping study chemotherapy.
References
Publications (0)
Data not yet available
No reference posted for this study.