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Sponsors and Collaborators: |
M.D. Anderson Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00075647 |
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 locally advanced or metastatic pancreatic cancer.
Condition | Intervention | Phase |
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Pancreatic Cancer |
Drug: temsirolimus |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Study of CCI-779 in Locally Advanced or Metastatic Pancreatic Cancer |
Study Start Date: | December 2003 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label study.
Patients receive CCI-779 IV over 30 minutes once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 13 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed adenocarcinoma of the pancreas
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
More than 2 months since prior adjuvant or neoadjuvant chemoradiotherapy for resected pancreatic cancer
More than 2 months since prior chemoradiotherapy for locally advanced pancreatic cancer
Endocrine therapy
Radiotherapy
Surgery
Other
United States, Texas | |
MD Anderson Cancer Center at University of Texas | |
Houston, Texas, United States, 77030-4009 |
Study Chair: | Henry Q. Xiong, MD, PhD | M.D. Anderson Cancer Center |
Investigator: | James L. Abbruzzese, MD | M.D. Anderson Cancer Center |
Study ID Numbers: | CDR0000347405, MDA-2003-0530, NCI-6182 |
Study First Received: | January 9, 2004 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00075647 History of Changes |
Health Authority: | United States: Federal Government |
stage II pancreatic cancer stage III pancreatic cancer recurrent pancreatic cancer adenocarcinoma of the pancreas stage IV pancreatic cancer |
Digestive System Diseases Digestive System Neoplasms Pancreatic Neoplasms Endocrine System Diseases Pancreatic Diseases Gastrointestinal Neoplasms |
Endocrinopathy Adenocarcinoma Pancrelipase Recurrence Endocrine Gland Neoplasms |
Neoplasms Digestive System Diseases Neoplasms by Site Digestive System Neoplasms |
Pancreatic Neoplasms Endocrine System Diseases Pancreatic Diseases Endocrine Gland Neoplasms |