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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: | Treatment, Open Label |
| 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
| 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 |
| ClinicalTrials.gov Identifier: | NCT00416767 History of Changes |
| 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 |
|
Antimetabolites Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Gastrointestinal Diseases Pancreatic Neoplasms Physiological Effects of Drugs Irinotecan Neoplasms, Nerve Tissue Leucovorin Pathologic Processes Neoplasms by Site Vitamins Therapeutic Uses |
Neoplasms, Germ Cell and Embryonal Syndrome Micronutrients Endocrine Gland Neoplasms Vitamin B Complex Neoplasms by Histologic Type Disease Digestive System Neoplasms Growth Substances Endocrine System Diseases Enzyme Inhibitors Adenoma, Islet Cell Malignant Carcinoid Syndrome Immunosuppressive Agents Pharmacologic Actions |