Clinical trial · Interventional
PS-341 in Treating Patients With Metastatic Neuroendocrine Tumors
Phase II Study of PS-341 in Metastatic Neuroendocrine Tumors
NCT00017199CI-TRIAL-00009224completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastrointestinal Carcinoid Tumor | Digestive System Neuroendocrine Tumor G1 | ALIAS | 0.90 |
| Islet Cell Tumor | Pancreatic Neuroendocrine Tumor | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bortezomib | Drug | Bortezomib | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 patientsReferences
Publications (0)
Data not yet available
No reference posted for this study.