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

June 6, 2001
January 30, 2013
April 2001
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT00017199 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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.

Interventional
Phase 2
Primary Purpose: Treatment
  • Gastrointestinal Carcinoid Tumor
  • Islet Cell Tumor
Drug: bortezomib
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
May 2007
Not Provided

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
Not Provided
Not Provided
Ohio State University Comprehensive Cancer Center
National Cancer Institute (NCI)
Study Chair: Manisha H. Shah, MD Ohio State University Comprehensive Cancer Center
National Cancer Institute (NCI)
May 2007

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