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Sorafenib in Treating Patients With Progressive Metastatic Neuroendocrine Tumors
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Mayo Clinic
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00131911
  Purpose

RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

PURPOSE: This phase II trial is studying how well sorafenib works in treating patients with progressive metastatic neuroendocrine tumors.


Condition Intervention Phase
Gastrointestinal Carcinoid Tumor
Islet Cell Tumor
Neoplastic Syndrome
Drug: sorafenib tosylate
Phase II

MedlinePlus related topics: Cancer Carcinoid Tumors
Drug Information available for: Sorafenib Sorafenib tosylate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase II Trial of Bay 43-9006 in Progressive Metastatic Neuroendocrine Tumors

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Confirmed response rate [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity [ Designated as safety issue: Yes ]
  • Biochemical levels and response [ Designated as safety issue: No ]
  • Survival time [ Designated as safety issue: No ]
  • Time to disease progression [ Designated as safety issue: No ]
  • Duration of response [ Designated as safety issue: No ]
  • Time to treatment failure [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: June 2005
Detailed Description:

OBJECTIVES:

Primary

  • Determine the objective tumor response rate in patients with progressive metastatic neuroendocrine tumors treated with sorafenib.

Secondary

  • Determine the adverse event rate in patients treated with this drug.
  • Determine time to progression and progression-free and overall survival of patients treated with this drug.
  • Determine improvement in circulating hormone levels in patients treated with this drug.

OUTLINE: This is a multicenter study. Patients are stratified according to tumor type (carcinoid vs islet cell/other well-differentiated tumor).

Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months until disease progression and then every 6 months for up to 2 years from study entry.

PROJECTED ACCRUAL: Approximately 38-90 patients (22-46 with carcinoid tumors and 12-39 with islet cell carcinoma/other well-differentiated tumors) will be accrued for this study within 3.2-7.5 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed neuroendocrine tumor

    • Carcinoid tumor OR islet cell carcinoma/other well-differentiated tumor

      • No anaplastic or high-grade histology
    • Metastatic disease
  • Measurable disease
  • No thyroid carcinoma of any histology, thymoma, or pheochromocytoma/paraganglioma
  • No known brain metastases

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • At least 24 weeks

Hematopoietic

  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • No bleeding diathesis

Hepatic

  • Bilirubin ≤ 2 times upper limit of normal (ULN)
  • AST ≤ 3 times ULN (5 times ULN if liver metastases are present)
  • INR normal
  • PTT normal

Renal

  • Creatinine ≤ 1.5 times ULN

Cardiovascular

  • No poorly controlled hypertension
  • No symptoms of congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia

Gastrointestinal

  • Able to swallow capsules intact
  • No gastrointestinal tract disease resulting in an inability to take oral medication (e.g., dysphagia)
  • No requirement for IV alimentation
  • No active peptic ulcer disease

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No ongoing or active infection
  • No psychiatric illness or social situation that would preclude study compliance
  • No other invasive malignancy within the past 3 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
  • No other uncontrolled illness

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • At least 4 weeks since prior interferon

Chemotherapy

  • No more than 1 prior systemic chemotherapy regimen

    • Chemoembolization is not considered systemic chemotherapy
  • At least 4 weeks since prior chemoembolization

Endocrine therapy

  • Prior or concurrent octreotide for symptomatic treatment allowed

Radiotherapy

  • At least 3 weeks since prior radiotherapy

Surgery

  • At least 4 weeks since prior major surgery
  • No prior procedures adversely affecting intestinal absorption

Other

  • Recovered from all prior therapy
  • At least 4 weeks since prior hepatic artery embolization
  • No other prior systemic therapy
  • No other concurrent investigational treatment
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No concurrent enzyme-inducing anticonvulsants (e.g., carbamazepine, phenobarbital, or phenytoin)
  • No concurrent rifampin
  • No concurrent Hypericum perforatum (St. John's wort)
  • No concurrent therapeutic anticoagulation

    • Concurrent prophylactic anticoagulation (i.e., low dose warfarin) of venous or arterial access devices allowed provided requirements for INR or PTT are met
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00131911

Locations
United States, Arizona
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States, 85259-5499
United States, District of Columbia
Howard University Cancer Center at Howard University Hospital
Washington, District of Columbia, United States, 20060
United States, Florida
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States, 32224
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
United States, Minnesota
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
United States, Missouri
Siteman Cancer Center at Barnes-Jewish Hospital
Saint Louis, Missouri, United States, 63110
United States, Wisconsin
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792-3236
Australia, Western Australia
Sir Charles Gairdner Hospital - Perth
Perth, Western Australia, Australia, 6009
Hong Kong
Prince of Wales Hospital
Shatin, New Territories, Hong Kong
Singapore
National Cancer Centre - Singapore
Singapore, Singapore, 169610
Sponsors and Collaborators
Mayo Clinic
Investigators
Study Chair: Timothy Hobday, MD Mayo Clinic
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000437792, MAYO-MC044H, NCI-7046
Study First Received: August 16, 2005
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00131911  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
metastatic gastrointestinal carcinoid tumor
recurrent gastrointestinal carcinoid tumor
gastrinoma
insulinoma
glucagonoma
pancreatic polypeptide tumor
somatostatinoma
recurrent islet cell carcinoma
WDHA syndrome

Study placed in the following topic categories:
Gastrointestinal Diseases
Pancreatic Neoplasms
Pancreatic Polypeptide
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Endocrine Gland Neoplasms
Digestive System Neoplasms
Carcinoma, Islet Cell
Serotonin Syndrome
Insulinoma
Endocrine System Diseases
Adenoma, Islet Cell
Malignant Carcinoid Syndrome
Carcinoid syndrome
Recurrence
Neuroendocrine Tumors
Carcinoma
Carcinoid tumor
Neuroectodermal Tumors
Gastrinoma
Digestive System Diseases
Gastrointestinal Neoplasms
Pancreatic Diseases
Carcinoid Tumor
Endocrinopathy
Adenocarcinoma
Sorafenib
Adenoma
Pancreatic islet cell tumors
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Disease
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Neoplasms, Nerve Tissue
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions
Neoplasms
Pathologic Processes
Neoplasms by Site
Syndrome
Therapeutic Uses

ClinicalTrials.gov processed this record on January 16, 2009