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Gefitinib 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: NCT00075439
  Purpose

RATIONALE: Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth.

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


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

MedlinePlus related topics: Cancer Carcinoid Tumors
Drug Information available for: ZD1839
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase II Trial Of ZD1839 (Iressa) In Metastatic Neuroendocrine Tumors

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

Primary Outcome Measures:
  • Proportion of successes [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity as assessed by NCI CTCAE v3.0 [ Designated as safety issue: Yes ]
  • Confirmed tumor response (partial and complete) [ Designated as safety issue: No ]
  • Survival [ 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 ]

Study Start Date: December 2003
Detailed Description:

OBJECTIVES:

Primary

  • Determine the 6-month progression-free survival rate in patients with progressive metastatic neuroendocrine tumors treated with gefitinib.

Secondary

  • Determine the objective tumor response rate in patients treated with this drug.
  • Determine time to progression and progression-free and overall survival in 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 disease type (carcinoid vs islet cell and other neuroendocrine tumors).

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

Patients are followed every 3 months until disease progression and then every 6 months for up to 2 years from study entry.

PROJECTED ACCRUAL: A total of 34-90 patients (22-51 for carcinoid stratum and 12-39 for islet cell/other neuroendocrine tumor stratum) will be accrued for this study within 9 months.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Histologically confirmed metastatic neuroendocrine neoplasm OR primary neuroendocrine tumor with clear clinical evidence of metastases

    • No anaplastic or high-grade histology
  • Measurable disease
  • Radiographic evidence of disease progression within the past 60 weeks after prior systemic therapy, chemoembolization, embolization, or observation and defined as 1 of the following:

    • Appearance of a new lesion
    • At least 20% increase in the longest diameter (LD) of any previously documented lesion OR an increase in the sum of the LDs of multiple lesions in aggregate of 20%
  • No thyroid carcinoma of any histology 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 at least 1,000/mm^3
  • Platelet count at least 75,000/mm^3
  • Hemoglobin at least 8.0 g/dL

Hepatic

  • Bilirubin no greater than 2 times upper limit of normal (ULN)
  • Alkaline phosphatase no greater than 3 times ULN*
  • AST no greater than 3 times ULN* NOTE: *5 times ULN if liver metastases are present

Renal

  • Creatinine no greater than 1.5 times ULN

Cardiovascular

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

Gastrointestinal

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

Ophthalmic

  • No known abnormality of the cornea, such as any of the following:

    • History of dry eye syndrome or Sjögren's syndrome
    • Congenital abnormality
    • Abnormal slit-lamp examination using a vital dye (e.g., fluorescein or Bengal-rose)
    • Abnormal corneal sensitivity test (e.g., Schirmer test)

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 uncontrolled illness
  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • At least 4 weeks since prior interferon injection

Chemotherapy

  • At least 4 weeks since prior chemotherapy
  • No more than 1 prior systemic chemotherapy regimen

    • Chemoembolization is not considered systemic chemotherapy
  • No concurrent chemotherapy

Endocrine therapy

  • At least 2 weeks since prior short-acting octreotide injection (6 weeks for long-acting injection)
  • Concurrent octreotide allowed provided a stable dose has been administered for at least 1 month and there is documented tumor progression on the current dose with no plan for increasing the dose

Radiotherapy

  • At least 3 weeks since prior radiotherapy
  • No concurrent radiotherapy

Surgery

  • At least 4 weeks since prior major surgery

Other

  • Recovered from prior therapy
  • At least 4 weeks since other prior systemic therapy
  • At least 4 weeks since prior hepatic artery embolization/chemoembolization
  • More than 7 days since prior administration of the following CYP3A4 inducers:

    • Phenytoin
    • Carbamazepine
    • Barbiturates
    • Rifampin
    • Oxcarbazepine
    • Rifapentine
    • Modafinil
    • Hypericum perforatum (St. John's wort)
  • No prior procedures adversely affecting intestinal absorption
  • No prior epidermal growth factor-targeted regimens (e.g., erlotinib, EKB-569, or gefitinib)
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No other concurrent investigational treatment
  • No concurrent CYP3A4 inducers
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00075439

Locations
United States, Arizona
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States, 85259
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
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: CDR0000346420, MAYO-MC0279, NCI-6113
Study First Received: January 9, 2004
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00075439  
Health Authority: United States: Federal Government

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

Study placed in the following topic categories:
Gastrointestinal Diseases
Pancreatic Neoplasms
Pancreatic Polypeptide
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Gefitinib
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
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 13, 2009