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Study of First-Line Therapy Comprising Leucovorin Calcium, Fluorouracil, and Irinotecan (FOLFIRI) in Patients With Progressive Locally Advanced or Metastatic Duodenal-Pancreatic Endocrine Tumors


Phase 2
18 Years
80 Years
Open (Enrolling)
Both
Gastrointestinal Carcinoid Tumor, Islet Cell Tumor, Neoplastic Syndrome

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Trial Information

Study of First-Line Therapy Comprising Leucovorin Calcium, Fluorouracil, and Irinotecan (FOLFIRI) in Patients With Progressive Locally Advanced or Metastatic Duodenal-Pancreatic Endocrine Tumors


OBJECTIVES:

Primary

- 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.

Secondary

- 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.

Inclusion Criteria


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 lesion

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Guillaume Cadiot

Investigator Role:

Study Chair

Investigator Affiliation:

CHU - Robert Debre

Authority:

United States: Federal Government

Study ID:

CDR0000453858

NCT ID:

NCT00416767

Start Date:

Completion Date:

Related Keywords:

  • Gastrointestinal Carcinoid Tumor
  • Islet Cell Tumor
  • Neoplastic Syndrome
  • metastatic gastrointestinal carcinoid tumor
  • recurrent gastrointestinal carcinoid tumor
  • regional gastrointestinal carcinoid tumor
  • gastrinoma
  • insulinoma
  • WDHA syndrome
  • glucagonoma
  • pancreatic polypeptide tumor
  • somatostatinoma
  • recurrent islet cell carcinoma
  • Neoplasms
  • Carcinoid Tumor
  • Neuroendocrine Tumors
  • Malignant Carcinoid Syndrome
  • Gastrointestinal Neoplasms
  • Adenoma, Islet Cell

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