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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

This study has been completed.
Information provided by (Responsible Party):
Federation Francophone de Cancerologie Digestive Identifier:
First received: December 27, 2006
Last updated: May 27, 2016
Last verified: May 2016

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.

Condition Intervention Phase
Gastrointestinal Carcinoid Tumor
Islet Cell Tumor
Neoplastic Syndrome
Drug: fluorouracil
Drug: irinotecan hydrochloride
Drug: leucovorin calcium
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study of First-Line Therapy Comprising Leucovorin Calcium, Fluorouracil, and Irinotecan (FOLFIRI) in Patients With Progressive Locally Advanced or Metastatic Duodenal-Pancreatic Endocrine Tumors

Resource links provided by NLM:

Further study details as provided by Federation Francophone de Cancerologie Digestive:

Enrollment: 20
Study Start Date: May 2004
Study Completion Date: July 2007
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FOLFIRI Drug: fluorouracil Drug: irinotecan hydrochloride Drug: leucovorin calcium

Detailed Description:



  • Determine the 6-month progression-free survival rate in patients with unresectable locally advanced or metastatic neuroendocrine tumors of the duodenum/pancreas treated with fluorouracil, leucovorin calcium, and irinotecan hydrochloride as first-line chemotherapy.


  • Determine tumor and biologic response at 6, 12, 18, and 24 months in patients treated with this regimen.
  • Determine the duration of response of the primary tumor in patients treated with this regimen.
  • Determine the tolerability of this regimen in these patients.
  • Determine the progression-free survival of patients treated with this regimen.
  • Determine the overall survival of patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive irinotecan hydrochloride IV over 90 minutes and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV over 46 hours on days 1 and 2. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed every 3 months for 1 year and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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


  • 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


  • 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 lesion
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Please refer to this study by its identifier: NCT00416767

Sponsors and Collaborators
Federation Francophone de Cancerologie Digestive
Study Chair: Guillaume Cadiot CHU - Robert Debre
  More Information

Cadiot 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.

Responsible Party: Federation Francophone de Cancerologie Digestive Identifier: NCT00416767     History of Changes
Other Study ID Numbers: CDR0000453858
Study First Received: December 27, 2006
Last Updated: May 27, 2016

Keywords provided by Federation Francophone de Cancerologie Digestive:
metastatic gastrointestinal carcinoid tumor
recurrent gastrointestinal carcinoid tumor
regional gastrointestinal carcinoid tumor
WDHA syndrome
pancreatic polypeptide tumor
recurrent islet cell carcinoma

Additional relevant MeSH terms:
Carcinoid Tumor
Neuroendocrine Tumors
Malignant Carcinoid Syndrome
Gastrointestinal Neoplasms
Adenoma, Islet Cell
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Pancreatic Neoplasms
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases
Calcium, Dietary
Bone Density Conservation Agents
Physiological Effects of Drugs
Antimetabolites processed this record on May 22, 2017