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Sponsors and Collaborators: |
Princess Margaret Hospital, Canada National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00093782 |
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 |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Study of CCI-779 in Metastatic Neuroendocrine Carcinomas |
Study Start Date: | December 2003 |
OBJECTIVES:
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed neuroendocrine tumor
Carcinoid histology OR carcinoma of pancreatic islet cell origin
Measurable disease
Documented progressive disease within the past 6 months, as defined by 1 of the following criteria:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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 |
Principal Investigator: | Lillian L. Siu, MD, FRCPC | Princess Margaret Hospital, Canada |
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 |
gastrinoma glucagonoma insulinoma somatostatinoma pancreatic polypeptide tumor |
WDHA syndrome recurrent gastrointestinal carcinoid tumor pulmonary carcinoid tumor metastatic gastrointestinal carcinoid tumor recurrent islet cell carcinoma |
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 |
Respiratory Tract Neoplasms Neoplasms Pathologic Processes Disease |
Neoplasms by Site Neoplasms by Histologic Type Syndrome Neoplasms, Nerve Tissue |