PS-341 in Treating Patients With Metastatic Neuroendocrine Tumors

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00017199
First received: June 6, 2001
Last updated: January 30, 2013
Last verified: May 2007
  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 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:

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
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: 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
Ohio State University Comprehensive Cancer Center
Investigators
Study Chair: Manisha H. Shah, MD Ohio State University Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00017199     History of Changes
Other Study ID Numbers: CDR0000068660, OSU-00H0328, NCI-1856
Study First Received: June 6, 2001
Last Updated: January 30, 2013
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:
Carcinoid Tumor
Neuroendocrine Tumors
Malignant Carcinoid Syndrome
Gastrointestinal Neoplasms
Adenoma, Islet Cell
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Adenoma
Pancreatic Neoplasms
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases
Bortezomib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 27, 2014