Trials Sponsors Conditions Drugs Pricing

Conditions

Gastrointestinal Carcinoid Tumor Islet Cell Tumor Neoplastic Syndrome

Keywords

metastatic gastrointestinal carcinoid tumorrecurrent gastrointestinal carcinoid tumorregional gastrointestinal carcinoid tumorgastrinomainsulinomaWDHA syndromeglucagonomapancreatic polypeptide tumorsomatostatinomarecurrent islet cell carcinoma

Study Arms (1)

FOLFIRI

EXPERIMENTAL

Drug: fluorouracilDrug: irinotecan hydrochlorideDrug: leucovorin calcium

Interventions

fluorouracilDrug

FOLFIRI

irinotecan hydrochlorideDrug

FOLFIRI

leucovorin calcium

Eligibility Criteria

Age18 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

Federation Francophone de Cancerologie Digestive
Otherlead

Related Publications (2)

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.
RESULT
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.
PMID: 21831734RESULT

MeSH Terms

Conditions

Adenoma, Islet CellNeoplasmsGastrinomaInsulinomaVipomaGlucagonomaSomatostatinomaCarcinoma, Islet Cell

Interventions

FluorouracilIrinotecanLeucovorin

Condition Hierarchy (Ancestors)

AdenomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypePancreatic Neoplasms

Study Officials

Guillaume Cadiot
CHU - Robert Debre
STUDY CHAIR

Enrollment

20 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

December 27, 2006

First Posted

December 28, 2006

Study Start

May 2004

Date type not reported

This date has not been verified as actual or estimated.

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

First Submitted

First Posted

Study Completion

Conditions

Keywords

Study Arms (1)

FOLFIRI

Interventions

Eligibility Criteria

Sponsors & Collaborators

Related Publications (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Intervention Hierarchy (Ancestors)

Source record

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

First Submitted

First Posted

Study Completion

Conditions

Keywords

Study Arms (1)

FOLFIRI

Interventions

Eligibility Criteria

Sponsors & Collaborators

Related Publications (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Intervention Hierarchy (Ancestors)

Source record