PS-341 in Treating Patients With Metastatic Neuroendocrine Tumors

NCT ID: NCT00017199

Last Updated: 2013-01-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-04-30
• Study Completion Date: 2007-05-31

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.

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.

Conditions

Gastrointestinal Carcinoid Tumor; Islet Cell Tumor

Study Design

• Primary Study Purpose: TREATMENT

Interventions

bortezomib

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Ohio State University Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Principal Investigators

Manisha H. Shah, MD

Role: STUDY_CHAIR

Ohio State University Comprehensive Cancer Center

Locations

University of Chicago Cancer Research Center

Chicago, Illinois, United States

Arthur G. James Cancer Hospital - Ohio State University

Columbus, Ohio, United States

Countries

United States

Other Identifiers

OSU-00H0328

Identifier Type: -

Identifier Source: secondary_id

NCI-1856

Identifier Type: -

Identifier Source: secondary_id

CDR0000068660

Identifier Type: -

Identifier Source: org_study_id