PS-341 in Treating Patients With Metastatic Neuroendocrine Tumors

Sponsor

Ohio State University Comprehensive Cancer Center (Other)

Overall Status

Completed

CT.gov ID

NCT00017199

Collaborator

National Cancer Institute (NCI) (NIH)

Locations

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gastrointestinal Carcinoid Tumor Islet Cell Tumor	Drug: bortezomib	Phase 2

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.

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

Official Title:

Phase II Study of PS-341 in Metastatic Neuroendocrine Tumors

Study Start Date :

Apr 1, 2001

Actual Study Completion Date :

May 1, 2007

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Chicago Cancer Research Center	Chicago	Illinois	United States	60637-1470
2	Arthur G. James Cancer Hospital - Ohio State University	Columbus	Ohio	United States	43210-1240