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| ID | Type | Description | Link |
|---|---|---|---|
| FFCD-0302 | |||
| EU-20544 | |||
| PFIZER-FFCD-0302 |
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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
Secondary
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FOLFIRI | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fluorouracil | Drug |
| ||
| irinotecan hydrochloride |
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:
Unresectable disease
Tumor differentiated and meets the following criteria:
Measurable or evaluable disease
Target lesions must meet 1 of the following criteria within the past 6 months:
Minimum size of lesions must be 1 of the following:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Guillaume Cadiot | CHU - Robert Debre | Study Chair |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | 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. | ||
| 21831734 | 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. |
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|
| leucovorin calcium | Drug |
|
| ID | Term |
|---|---|
| D007516 | Adenoma, Islet Cell |
| D009369 | Neoplasms |
| D015408 | Gastrinoma |
| D007340 | Insulinoma |
| D003969 | Vipoma |
| D005935 | Glucagonoma |
| D013005 | Somatostatinoma |
| D018273 | Carcinoma, Islet Cell |
| ID | Term |
|---|---|
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D010190 | Pancreatic Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D018278 | Carcinoma, Neuroendocrine |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
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| ID | Term |
|---|---|
| D005472 | Fluorouracil |
| D000077146 | Irinotecan |
| D002955 | Leucovorin |
| ID | Term |
|---|---|
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
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