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PS-341 in Treating Patients With Metastatic Neuroendocrine Tumors

This study has been completed.
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: June 6, 2001
Last updated: January 30, 2013
Last verified: May 2007

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of PS-341 in treating patients who have metastatic neuroendocrine tumors.

Condition Intervention Phase
Gastrointestinal Carcinoid Tumor Islet Cell Tumor Drug: bortezomib Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase II Study of PS-341 in Metastatic Neuroendocrine Tumors

Resource links provided by NLM:

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

Study Start Date: April 2001
Study Completion Date: May 2007
Detailed Description:


  • Determine the objective response rate of patients with metastatic neuroendocrine tumors treated with bortezomib.
  • Determine the toxicity of this drug in this patient population.
  • Determine the pharmacodynamics to correlate proteasome inhibition and efficacy of this drug in this patient population.

OUTLINE: This is a multicenter study.

Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for at least 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving complete response (CR) receive 2 additional courses beyond CR.

PROJECTED ACCRUAL: A total of 16-25 patients will be accrued for this study within 6 months.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed metastatic carcinoid tumor or islet cell tumor

    • Well-differentiated neuroendocrine tumor OR
    • Well-differentiated neuroendocrine carcinoma
  • Measurable disease in at least 1 dimension

    • At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
    • The following are considered nonmeasurable:

      • Lesions in a previously irradiated area
      • Bone lesions
      • Leptomeningeal disease
      • Ascites
      • Pleural/pericardial effusion
      • Lymphangitis cutis/pulmonis
      • Abdominal masses that are not confirmed and followed
      • Cystic lesions



  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • At least 6 months


  • Leukocyte count at least 3,000/mm^3
  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3


  • Bilirubin no greater than 1.5 mg/dL
  • AST/ALT no greater than 2.5 times upper limit of normal


  • Creatinine no greater than 1.5 mg/dL


  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia


  • No other uncontrolled illness
  • No ongoing active infection
  • No psychiatric illness or social situation that would preclude study
  • No history of allergic reaction to compounds of similar chemical or biologic composition to bortezomib
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception


Biologic therapy:

  • At least 4 weeks since prior immunotherapy (interferon alfa)


  • No more than 1 prior systemic chemotherapy regimen (except hepatic artery chemoembolization)
  • At least 4 weeks since prior systemic chemotherapy (6 weeks for nitrosoureas)
  • At least 12 weeks since prior hepatic artery chemoembolization (unless liver lesions are not indicator lesions)
  • Stable dose long-acting octreotide therapy (Sandostatin LAR) within the past 3 months allowed
  • Concurrent subcutaneous octreotide for breakthrough symptomatic relief allowed

Endocrine therapy:

  • Not specified


  • See Disease Characteristics
  • At least 4 weeks since prior radiotherapy


  • Not specified


  • No other concurrent investigational agents, commercial agents, or therapies
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  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 identifier: NCT00017199

United States, Illinois
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
United States, Ohio
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, United States, 43210-1240
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
National Cancer Institute (NCI)
Study Chair: Manisha H. Shah, MD Ohio State University Comprehensive Cancer Center
  More Information Identifier: NCT00017199     History of Changes
Other Study ID Numbers: CDR0000068660
Study First Received: June 6, 2001
Last Updated: January 30, 2013

Keywords provided by National Cancer Institute (NCI):
metastatic gastrointestinal carcinoid tumor

Additional relevant MeSH terms:
Neuroendocrine Tumors
Carcinoid Tumor
Malignant Carcinoid Syndrome
Gastrointestinal Neoplasms
Adenoma, Islet Cell
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Neoplasms, Glandular and Epithelial
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Pancreatic Neoplasms
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases
Antineoplastic Agents processed this record on September 21, 2017