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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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ClinicalTrials.gov Identifier: NCT00416767
Recruitment Status : Completed
First Posted : December 28, 2006
Last Update Posted : May 30, 2016
Sponsor:
Information provided by (Responsible Party):
Federation Francophone de Cancerologie Digestive

Tracking Information
First Submitted Date  ICMJE December 27, 2006
First Posted Date  ICMJE December 28, 2006
Last Update Posted Date May 30, 2016
Study Start Date  ICMJE May 2004
Actual Primary Completion Date January 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00416767 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE Study of First-Line Therapy Comprising Leucovorin Calcium, Fluorouracil, and Irinotecan (FOLFIRI) in Patients With Progressive Locally Advanced or Metastatic Duodenal-Pancreatic Endocrine Tumors
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Gastrointestinal Carcinoid Tumor
  • Islet Cell Tumor
  • Neoplastic Syndrome
Intervention  ICMJE
  • Drug: fluorouracil
  • Drug: irinotecan hydrochloride
  • Drug: leucovorin calcium
Study Arms  ICMJE Experimental: FOLFIRI
Interventions:
  • Drug: fluorouracil
  • Drug: irinotecan hydrochloride
  • Drug: leucovorin calcium
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December¬†27,¬†2006)
20
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2007
Actual Primary Completion Date January 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00416767
Other Study ID Numbers  ICMJE CDR0000453858
FFCD-0302
EU-20544
PFIZER-FFCD-0302
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Federation Francophone de Cancerologie Digestive
Study Sponsor  ICMJE Federation Francophone de Cancerologie Digestive
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Guillaume Cadiot CHU - Robert Debre
PRS Account Federation Francophone de Cancerologie Digestive
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP