PS-341 in Treating Patients With Metastatic Neuroendocrine Tumors
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Gastrointestinal Carcinoid Tumor Islet Cell Tumor |
Drug: bortezomib |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Phase II Study of PS-341 in Metastatic Neuroendocrine Tumors |
| Study Start Date: | April 2001 |
| Study Completion Date: | May 2007 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| United States, Illinois | |
| University of Chicago Cancer Research Center | |
| Chicago, Illinois, United States, 60637-1470 | |
| United States, Ohio | |
| Arthur G. James Cancer Hospital - Ohio State University | |
| Columbus, Ohio, United States, 43210-1240 | |
| Study Chair: | Manisha H. Shah, MD | Ohio State University Comprehensive Cancer Center |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00017199 History of Changes |
| Other Study ID Numbers: | CDR0000068660, OSU-00H0328, NCI-1856 |
| Study First Received: | June 6, 2001 |
| Last Updated: | January 30, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
metastatic gastrointestinal carcinoid tumor gastrinoma insulinoma somatostatinoma glucagonoma |
Additional relevant MeSH terms:
|
Carcinoid Tumor Neuroendocrine Tumors Malignant Carcinoid Syndrome Gastrointestinal Neoplasms Adenoma, Islet Cell Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Digestive System Neoplasms Neoplasms by Site |
Digestive System Diseases Gastrointestinal Diseases Adenoma Pancreatic Neoplasms Endocrine Gland Neoplasms Pancreatic Diseases Endocrine System Diseases Bortezomib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 18, 2013