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

Phase 2

Completed

• Conditions: Gastrointestinal Carcinoid Tumor; Neoplastic Syndrome; Islet Cell Tumor
• Interventions: Drug: fluorouracil; Drug: irinotecan hydrochloride; Drug: leucovorin calcium

• Registration Number: NCT00416767
• Lead Sponsor: Federation Francophone de Cancerologie Digestive

Brief 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.

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2004-05
• Primary Completion: 2006-01
• Study First Submitted: 2006-12-27
• Study First Submitted QC: 2006-12-27
• Study First Posted: 2006-12-28
• Study Completion: 2007-07
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-27
• Last Update Posted: 2016-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FOLFIRI	fluorouracil	-
FOLFIRI	leucovorin calcium	-
FOLFIRI	irinotecan hydrochloride	-