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

Study Overview

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

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.

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.

Gastrointestinal Carcinoid Tumor
Islet Cell Tumor
Neoplastic Syndrome

DRUG: fluorouracil
DRUG: irinotecan hydrochloride
DRUG: leucovorin calcium

CDR0000453858
FFCD-0302
EU-20544
PFIZER-FFCD-0302

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2006-12-27	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2016-05-27
First Submitted that Met QC Criteria 2006-12-27	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2016-05-30
First Posted (ESTIMATED) 2006-12-28	Results First Posted N/A	Last Verified 2016-05

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: FOLFIRI	DRUG: fluorouracil DRUG: irinotecan hydrochloride DRUG: leucovorin calcium

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: FOLFIRI

DRUG: fluorouracil

DRUG: irinotecan hydrochloride

DRUG: leucovorin calcium

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_CHAIR: Guillaume Cadiot, CHU - Robert Debre

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.
Brixi-Benmansour H, Jouve JL, Mitry E, Bonnetain F, Landi B, Hentic O, Bedenne L, Cadiot G. Phase II study of first-line FOLFIRI for progressive metastatic well-differentiated pancreatic endocrine carcinoma. Dig Liver Dis. 2011 Nov;43(11):912-6. doi: 10.1016/j.dld.2011.07.001. Epub 2011 Aug 9.

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Clinical Trial Record