PS-341 in Treating Patients With Metastatic Neuroendocrine Tumors

Gastrointestinal Carcinoid Tumor Clinical Trial

Official title:

Phase II Study of PS-341 in Metastatic Neuroendocrine Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00017199
• Other study ID #: CDR0000068660
• Secondary ID: OSU-00H0328NCI-1
• Status: Completed
• Phase: Phase 2
• First received: June 6, 2001
• Last updated: January 30, 2013
• Start date: April 2001
• Est. completion date: May 2007

Study information

• Verified date: May 2007
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoid Tumor
• Gastrointestinal Carcinoid Tumor
• Gastrointestinal Neoplasms
• Islet Cell Tumor
• Malignant Carcinoid Syndrome
• Neoplasms
• Neuroendocrine Tumors

Intervention

Drug:
• bortezomib

Locations

Country	Name	City	State
United States	University of Chicago Cancer Research Center	Chicago	Illinois
United States	Arthur G. James Cancer Hospital - Ohio State University	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,