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

Federation Francophone de Cancerologie Digestive

Status and phase

Completed

Phase 2

Conditions

Islet Cell Tumor

Gastrointestinal Carcinoid Tumor

Neoplastic Syndrome

Treatments

Drug: irinotecan hydrochloride

Drug: fluorouracil

Drug: leucovorin calcium

Study type

Interventional

Funder types

Other

Identifiers

NCT00416767

EU-20544

PFIZER-FFCD-0302

FFCD-0302

CDR0000453858

Details and patient eligibility

About

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.

Full description

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.

Enrollment

20 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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