PS-341 in Treating Patients With Metastatic Neuroendocrine Tumors

NCT00017199 | Completed Phase 2

• 3 other identifiers: CDR0000068660OSU-00H0328NCI-1856
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Gastrointestinal Carcinoid Tumor; Islet Cell Tumor

Keywords

metastatic gastrointestinal carcinoid tumor; gastrinoma; insulinoma; somatostatinoma; glucagonoma

Interventions

bortezomib DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

University of Chicago Cancer Research Center

Chicago, Illinois, 60637-1470, United States

Location

Arthur G. James Cancer Hospital - Ohio State University

Columbus, Ohio, 43210-1240, United States

Location

MeSH Terms

Conditions

Adenoma, Islet Cell; Gastrinoma; Insulinoma; Somatostatinoma; Glucagonoma

Interventions

Bortezomib

Condition Hierarchy (Ancestors)

Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Pancreatic Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Carcinoma, Islet Cell; Adenocarcinoma; Carcinoma; Carcinoma, Neuroendocrine; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Manisha H. Shah, MD

  Ohio State University Comprehensive Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 6, 2001
• First Posted: February 16, 2004
• Study Start: April 1, 2001
• Study Completion: May 1, 2007
• Last Updated: January 31, 2013

Record last verified: 2007-05

Locations

US (2)