Back to resultsCombination 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
Primary Purpose
Gastrointestinal Carcinoid Tumor, Islet Cell Tumor, Neoplastic Syndrome
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
fluorouracil
irinotecan hydrochloride
leucovorin calcium
Sponsored by
About this trial
This is an interventional treatment trial for Gastrointestinal Carcinoid Tumor focused on measuring 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
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
FOLFIRI
Arm Description
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00416767
First Posted
December 27, 2006
Last Updated
May 27, 2016
Sponsor
Federation Francophone de Cancerologie Digestive
1. Study Identification
Unique Protocol Identification Number
NCT00416767
Brief Title
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
Official Title
Study of First-Line Therapy Comprising Leucovorin Calcium, Fluorouracil, and Irinotecan (FOLFIRI) in Patients With Progressive Locally Advanced or Metastatic Duodenal-Pancreatic Endocrine Tumors
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
May 2004 (undefined)
Primary Completion Date
January 2006 (Actual)
Study Completion Date
July 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Federation Francophone de Cancerologie Digestive
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FOLFIRI
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
fluorouracil
Intervention Type
Drug
Intervention Name(s)
irinotecan hydrochloride
Intervention Type
Drug
Intervention Name(s)
leucovorin calcium
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guillaume Cadiot
Organizational Affiliation
CHU - Robert Debre
Official's Role
Study Chair
12. IPD Sharing Statement
Citations:
Citation
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.
Results Reference
result
PubMed Identifier
21831734
Citation
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.
Results Reference
result
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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
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