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Phase II Study of PS-341 in Metastatic Neuroendocrine Tumors


Phase 2
18 Years
N/A
Not Enrolling
Both
Gastrointestinal Carcinoid Tumor, Islet Cell Tumor

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Trial Information

Phase II Study of PS-341 in Metastatic Neuroendocrine Tumors


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.

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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Manisha H. Shah, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Ohio State University Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000068660

NCT ID:

NCT00017199

Start Date:

April 2001

Completion Date:

May 2007

Related Keywords:

  • Gastrointestinal Carcinoid Tumor
  • Islet Cell Tumor
  • metastatic gastrointestinal carcinoid tumor
  • gastrinoma
  • insulinoma
  • somatostatinoma
  • glucagonoma
  • Carcinoid Tumor
  • Neuroendocrine Tumors
  • Malignant Carcinoid Syndrome
  • Gastrointestinal Neoplasms
  • Adenoma, Islet Cell

Name

Location

University of Chicago Cancer Research CenterChicago, Illinois  60637
Arthur G. James Cancer Hospital - Ohio State UniversityColumbus, Ohio  43210