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CCI-779 in Treating Patients With Progressive Metastatic Neuroendocrine Tumors
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Princess Margaret Hospital, Canada
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00093782
  Purpose

RATIONALE: Drugs used in chemotherapy, such as CCI-779, work in different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: This phase II trial is studying how well CCI-779 works in treating patients with progressive metastatic neuroendocrine tumors.


Condition Intervention Phase
Gastrointestinal Carcinoid Tumor
Islet Cell Tumor
Lung Cancer
Neoplastic Syndrome
Drug: temsirolimus
Phase II

MedlinePlus related topics: Cancer Carcinoid Tumors Lung Cancer
Drug Information available for: CCI 779
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase II Study of CCI-779 in Metastatic Neuroendocrine Carcinomas

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

Study Start Date: December 2003
Detailed Description:

OBJECTIVES:

  • Determine the objective tumor response rate (i.e., partial or complete response) in patients with progressive metastatic neuroendocrine tumors treated with CCI-779.
  • Determine the stable disease rate and duration, time to disease progression, median survival time, and 1-year survival rate in patients treated with this drug.
  • Determine the toxicity of this drug in these patients.

OUTLINE: This is an open-label, multicenter study.

Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) or partial response (PR) receive 2 additional courses beyond CR or PR.

Patients are followed for survival.

PROJECTED ACCRUAL: A total of 15-35 patients will be accrued for this study within 5-15 months.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed neuroendocrine tumor

    • Carcinoid histology OR carcinoma of pancreatic islet cell origin

      • No small cell variant, endocrine organ carcinomas, or adrenal gland malignancies (including paragangliomas)
    • Metastatic disease
  • Measurable disease

    • At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
  • Not amenable to surgery
  • Documented progressive disease within the past 6 months, as defined by 1 of the following criteria:

    • At least 25% increase in radiologically or clinically measurable disease
    • Appearance of new lesions
    • Deterioration in clinical status
  • Must have tumor lesions accessible for biopsy
  • No known brain metastases

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2 OR
  • Karnofsky 60-100%

Life expectancy

  • More than 3 months

Hematopoietic

  • WBC ≥ 3,000/mm^3
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3

Hepatic

  • Bilirubin ≤ 1.25 times upper limit of normal (ULN)
  • AST and ALT ≤ 3 times ULN (< 5 times ULN if liver metastases are present)

Renal

  • Creatinine ≤ 1.5 times ULN OR
  • Creatinine clearance ≥ 60 mL/min

Cardiovascular

  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No active or ongoing infection
  • No history of allergic reaction attributed to compounds of similar chemical or biological composition to CCI-779
  • No psychiatric illness or social situation that would preclude study compliance
  • No other uncontrolled illness
  • No other malignancy within the past 3 years except curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No concurrent prophylactic hematopoietic colony-stimulating factors

Chemotherapy

  • More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered

Endocrine therapy

  • Concurrent chronic somatostatin analogues for symptom control allowed provided treatment was initiated > 3 months before study entry

Radiotherapy

  • More than 4 weeks since prior radiotherapy, including radioactive octreotide, and recovered

Surgery

  • More than 6 weeks since prior surgery

Other

  • More than 6 weeks since prior local therapy (e.g., chemoembolization or bland embolization)
  • More than 4 weeks since prior investigational agents
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No other concurrent anticancer therapy
  • No other concurrent investigational agents
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00093782

Locations
United States, Illinois
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood, Illinois, United States, 60153
Central Illinois Hematology Oncology Center
Springfield, Illinois, United States, 62701
Decatur Memorial Hospital Cancer Care Institute
Decatur, Illinois, United States, 62526
Evanston Northwestern Health Care - Evanston Hospital
Evanston, Illinois, United States, 60201-1781
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
La Grange Memorial Hospital
La Grange, Illinois, United States, 60525
Louis A. Weiss Memorial Hospital
Chicago, Illinois, United States, 60640
Oncology/Hematology Associates of Central Illinois, P.C.
Peoria, Illinois, United States, 61615-7828
Ingalls Cancer Care Center at Ingalls Memorial Hospital
Harvey, Illinois, United States, 60426
United States, Indiana
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States, 46601
Fort Wayne Medical Oncology and Hematology, Incorporated
Fort Wayne, Indiana, United States, 46885-5099
United States, Michigan
Oncology Care Associates, P.L.L.C.
Saint Joseph, Michigan, United States, 49085
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
United States, Wisconsin
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, United States, 53226
Canada, Ontario
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Margaret and Charles Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
Ottawa Hospital Regional Cancer Centre - General Campus
Ottawa, Ontario, Canada, K1H 8L6
London Regional Cancer Program at London Health Sciences Centre
London, Ontario, Canada, N6A 4L6
Sponsors and Collaborators
Princess Margaret Hospital, Canada
Investigators
Principal Investigator: Lillian L. Siu, MD, FRCPC Princess Margaret Hospital, Canada
  More Information

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

Study ID Numbers: CDR0000390249, PMH-PHL-021, NCI-6171
Study First Received: October 6, 2004
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00093782  
Health Authority: United States: Federal Government

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

Study placed in the following topic categories:
Thoracic Neoplasms
Carcinoma, Neuroendocrine
Gastrointestinal Diseases
Pancreatic Neoplasms
Pancreatic Polypeptide
Respiratory Tract Diseases
Lung Neoplasms
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
Lung Diseases
Pancreatic Diseases
Gastrointestinal Neoplasms
Carcinoid Tumor
Endocrinopathy

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms
Pathologic Processes
Disease
Neoplasms by Site
Neoplasms by Histologic Type
Syndrome
Neoplasms, Nerve Tissue

ClinicalTrials.gov processed this record on January 14, 2009