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

NCT00416767 | Completed Phase 2

• 4 other identifiers: CDR0000453858FFCD-0302EU-20544PFIZER-FFCD-0302
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Gastrointestinal Carcinoid Tumor; Islet Cell Tumor; Neoplastic Syndrome

Keywords

metastatic gastrointestinal carcinoid tumor; recurrent gastrointestinal carcinoid tumor; regional gastrointestinal carcinoid tumor; gastrinoma; insulinoma; WDHA syndrome; glucagonoma; pancreatic polypeptide tumor; somatostatinoma; recurrent islet cell carcinoma

Study Arms (1)

FOLFIRI

EXPERIMENTAL

Drug: fluorouracil; Drug: irinotecan hydrochloride; Drug: leucovorin calcium

Interventions

fluorouracil DRUG

FOLFIRI

irinotecan hydrochloride DRUG

FOLFIRI

leucovorin calcium DRUG

FOLFIRI

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Federation Francophone de Cancerologie Digestive: lead

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: 21831734 RESULT

MeSH Terms

Conditions

Adenoma, Islet Cell; Neoplasms; Gastrinoma; Insulinoma; Vipoma; Glucagonoma; Somatostatinoma; Carcinoma, Islet Cell

Interventions

Fluorouracil; Irinotecan; Leucovorin

Condition Hierarchy (Ancestors)

Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Pancreatic Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Adenocarcinoma; Carcinoma; Carcinoma, Neuroendocrine; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Camptothecin; Alkaloids; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes

Study Officials

• Guillaume Cadiot

  CHU - Robert Debre

  STUDY CHAIR

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 1, 2004
• Primary Completion: January 1, 2006
• Study Completion: July 1, 2007
• Last Updated: May 30, 2016

Record last verified: 2016-05