Clinical trial · Interventional
Combination Chemotherapy as First-Line Therapy in Treating Patients With Locally Advanced or Metastatic Neuroendocrine Tumors of the Duodenum or Pancreas That Cannot Be Removed By Surgery
Study of First-Line Therapy Comprising Leucovorin Calcium, Fluorouracil, and Irinotecan (FOLFIRI) in Patients With Progressive Locally Advanced or Metastatic Duodenal-Pancreatic Endocrine Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy, such as fluorouracil, leucovorin, and irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase II trial is studying how well combination chemotherapy works as first-line therapy in treating patients with locally advanced or metastatic neuroendocrine tumors of the duodenum or pancreas that cannot be removed by surgery.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastrointestinal Carcinoid Tumor | Digestive System Neuroendocrine Tumor G1 | ALIAS | 0.90 |
| Islet Cell Tumor | Pancreatic Neuroendocrine Tumor | ALIAS | 0.90 |
| Neoplastic Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| fluorouracil | Drug | Fluorouracil | ALIAS |
| irinotecan hydrochloride | Drug | Irinotecan | ALIAS |
| leucovorin calcium | Drug | Leucovorin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- FOLFIRI
- interventionNames
- Drug: fluorouracil
- Drug: irinotecan hydrochloride
- Drug: leucovorin calcium
Primary outcomes (0)
[]Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Diagnosis of neuroendocrine tumor of the duodenum/pancreas by histology or bone scan
* Functional or nonfunctional tumor
* Tumor meets ≥ 1 of the following criteria:
* Hepatic or extrahepatic metastases
* Progressive locally advanced tumor (primary or adenopathies)
* Unresectable disease
* Tumor differentiated and meets the following criteria:
* Ki 67 ≤ 15%
* Less than 10 mitoses per 10 large fields
* Measurable or evaluable disease
* Target lesions must meet 1 of the following criteria within the past 6 months:
* Increase of 20% in the longest diameter
* New metastases detected
* Minimum size of lesions must be 1 of the following:
* More than 15 mm for metastases
* More than 50 mm for primary tumor or local lymph nodes
PATIENT CHARACTERISTICS:
* WHO performance status 0-2
* Creatinine ≤ 1.5 mg/dL
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Bilirubin ≤ 1.8 mg/dL
* No coronary insufficiency or symptomatic cardiac disease
* No intestinal obstruction, enteropathy, or uncontrolled chronic diarrhea
* No Gilbert's disease
* No psychological, social, familial, or geographic condition that would preclude study treatment
* Not pregnant or nursing
* Fertile patients must use effective contraception during and for 6 months after completion of study therapy
* No other condition that would preclude study therapy
PRIOR CONCURRENT THERAPY:
* No prior adjuvant radiotherapy
* At least 3 months since prior interferon
* Prior somatostatin analogs or antisecretories allowed
* No other prior treatment for this cancer
* No concurrent radiotherapy to the target lesionReferences
Publications (2)
- RESULTCadiot G, Bonnetain F, Landi B, et al.: Simplified LV5FU2-irinotecan (FOLFIRI) in the first-line therapy of well-differentiated endocrine carcinomas of the duodeno- pancreatic area: preliminary results of the FFCD 0302 phase II trial with GTE participation. [Abstract] J Clin Oncol 25 (Suppl 18): A-4620, 2007.
- RESULTBrixi-Benmansour H, Jouve JL, Mitry E, Bonnetain F, Landi B, Hentic O, Bedenne L, Cadiot G. Phase II study of first-line FOLFIRI for progressive metastatic well-differentiated pancreatic endocrine carcinoma. Dig Liver Dis. 2011 Nov;43(11):912-6. doi: 10.1016/j.dld.2011.07.001. Epub 2011 Aug 9. PMID 21831734