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

• Status: Completed
• Trial end date: 2007-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Federation Francophone de Cancerologie Digestive
• Treatments: Calcium; Calcium, Dietary; Fluorouracil; Irinotecan; Leucovorin; Levoleucovorin

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