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| Sponsor: | Federation Francophone de Cancerologie Digestive |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00416767 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Gastrointestinal Carcinoid Tumor Islet Cell Tumor Neoplastic Syndrome |
Drug: fluorouracil Drug: irinotecan hydrochloride Drug: leucovorin calcium |
Phase II |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| 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 |
| Estimated Enrollment: | 20 |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Functional or nonfunctional tumor
Tumor meets ≥ 1 of the following criteria:
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:
Contacts and Locations
More Information
| ClinicalTrials.gov Identifier: | NCT00416767 History of Changes |
| Other Study ID Numbers: | CDR0000453858, FFCD-0302, EU-20544, PFIZER-FCD-0302, PFIZER-FFCD-0302 |
| Study First Received: | December 27, 2006 |
| Last Updated: | July 23, 2008 |
| Health Authority: | United States: Federal Government |
|
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 |
|
Neoplasms Carcinoid Tumor Neuroendocrine Tumors Malignant Carcinoid Syndrome Gastrointestinal Neoplasms Adenoma, Islet Cell Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Digestive System Neoplasms Neoplasms by Site |
Digestive System Diseases Gastrointestinal Diseases Adenoma Pancreatic Neoplasms Endocrine Gland Neoplasms Pancreatic Diseases Endocrine System Diseases Fluorouracil Irinotecan Camptothecin Leucovorin Levoleucovorin Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |