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PS-341 in Treating Patients With Metastatic Neuroendocrine Tumors
This study has been completed.
Study NCT00017199   Information provided by National Cancer Institute (NCI)
First Received: June 6, 2001   Last Updated: July 23, 2008   History of Changes

June 6, 2001
July 23, 2008
April 2001
 
 
 
Complete list of historical versions of study NCT00017199 on ClinicalTrials.gov Archive Site
 
 
 
PS-341 in Treating Patients With Metastatic Neuroendocrine Tumors
Phase II Study of PS-341 in Metastatic Neuroendocrine Tumors

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.

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.

Phase II
Interventional
Treatment
  • Gastrointestinal Carcinoid Tumor
  • Islet Cell Tumor
Drug: bortezomib
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
 

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00017199
 
CDR0000068660, OSU-00H0328, NCI-1856
Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
National Cancer Institute (NCI)
Study Chair: Manisha H. Shah, MD Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
National Cancer Institute (NCI)
May 2007

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