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PS-341 in Treating Patients With Metastatic Neuroendocrine Tumors
This study has been completed.
First Received: June 6, 2001   Last Updated: July 23, 2008   History of Changes
Sponsor: Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00017199
  Purpose

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 II

Study Type: Interventional
Study Design: 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
Detailed Description:

OBJECTIVES:

  • 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • At least 6 months

Hematopoietic:

  • 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

Hepatic:

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

Renal:

  • Creatinine no greater than 1.5 mg/dL

Cardiovascular:

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

Other:

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

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

Chemotherapy:

  • 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

Radiotherapy:

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

Surgery:

  • Not specified

Other:

  • No other concurrent investigational agents, commercial agents, or therapies
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00017199

Locations
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
Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
Investigators
Study Chair: Manisha H. Shah, MD Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000068660, OSU-00H0328, NCI-1856
Study First Received: June 6, 2001
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00017199     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
metastatic gastrointestinal carcinoid tumor
gastrinoma
insulinoma
somatostatinoma
glucagonoma

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Diseases
Antineoplastic Agents
Pancreatic Neoplasms
Neoplasms, Nerve Tissue
Neoplasms by Site
Neoplasms, Germ Cell and Embryonal
Therapeutic Uses
Endocrine Gland Neoplasms
Neoplasms by Histologic Type
Digestive System Neoplasms
Bortezomib
Endocrine System Diseases
Enzyme Inhibitors
Adenoma, Islet Cell
Malignant Carcinoid Syndrome
Pharmacologic Actions
Protease Inhibitors
Carcinoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms
Digestive System Diseases
Gastrointestinal Neoplasms
Pancreatic Diseases
Carcinoid Tumor
Adenocarcinoma
Adenoma
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 22, 2009