PS-341 in Treating Patients With Metastatic Neuroendocrine Tumors

• Status: Completed
• Trial end date: 2007-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ohio State University Comprehensive Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Bortezomib

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