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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2007 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00416767
First received: December 27, 2006
Last updated: July 23, 2008
Last verified: June 2007
  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 2

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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 20
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00416767

Sponsors and Collaborators
Federation Francophone de Cancerologie Digestive
Investigators
Study Chair: Guillaume Cadiot CHU - Robert Debre
  More Information

Additional Information:
Publications:
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.

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

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
Carcinoid Tumor
Gastrointestinal Neoplasms
Malignant Carcinoid Syndrome
Neoplasms
Syndrome
Adenocarcinoma
Carcinoma
Digestive System Diseases
Digestive System Neoplasms
Disease
Gastrointestinal Diseases
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Pathologic Processes
Fluorouracil
Irinotecan
Leucovorin
Levoleucovorin
Antidotes
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Enzyme Inhibitors
Growth Substances

ClinicalTrials.gov processed this record on October 20, 2014