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Tracking Information | |||||
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First Received Date ICMJE | October 6, 2004 | ||||
Last Updated Date | July 23, 2008 | ||||
Start Date ICMJE | December 2003 | ||||
Current Primary Outcome Measures ICMJE | |||||
Original Primary Outcome Measures ICMJE | |||||
Change History | Complete list of historical versions of study NCT00093782 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE | |||||
Original Secondary Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | CCI-779 in Treating Patients With Progressive Metastatic Neuroendocrine Tumors | ||||
Official Title ICMJE | A Phase II Study of CCI-779 in Metastatic Neuroendocrine Carcinomas | ||||
Brief Summary | 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. |
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Detailed Description | 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. |
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Study Phase | Phase II | ||||
Study Type ICMJE | Interventional | ||||
Study Design ICMJE | Treatment, Open Label | ||||
Condition ICMJE |
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Intervention ICMJE | Drug: temsirolimus | ||||
Study Arms / Comparison Groups | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Enrollment ICMJE | |||||
Completion Date | |||||
Primary Completion Date | |||||
Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY: Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United States, Canada | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID ICMJE | NCT00093782 | ||||
Responsible Party | |||||
Study ID Numbers ICMJE | CDR0000390249, PMH-PHL-021, NCI-6171 | ||||
Study Sponsor ICMJE | Princess Margaret Hospital, Canada | ||||
Collaborators ICMJE | National Cancer Institute (NCI) | ||||
Investigators ICMJE |
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Information Provided By | National Cancer Institute (NCI) | ||||
Verification Date | January 2006 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |