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Descriptive Information | ||||
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Brief Title ICMJE | CCI-779 in Treating Patients With Advanced Solid Tumors | |||
Official Title ICMJE | A Phase I Study of the Safety, Tolerability, and Pharmacokinetics of Intravenous CCI-779 Given Once Daily for 5 Days Every 2 Weeks to Patients With Advanced Solid Tumors | |||
Brief Summary | RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of CCI-779 in treating patients who have advanced solid tumors. | |||
Detailed Description | OBJECTIVES:
OUTLINE: This is an open-label, dose-escalation study.
The maximum tolerated dose for part I is defined as the dose level at which 33% of patients experience dose limiting toxicity.
PROJECTED ACCRUAL: Approximately 20 patients will be accrued for part I for this study within 8 months, and 12 patients will be accrued for part II within 7 months. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE |
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Intervention ICMJE | Drug: temsirolimus
?Part I: Patients receive CCI-779 IV over 30 minutes on days 1-5, followed by a 9 day rest period. Treatment courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. The maximum tolerated dose for part I is defined as the dose level at which 33% of patients experience dose limiting toxicity. ?Part II: Patients receive the same treatment schedule as part I. Three patients with CNS tumors are entered at the dose of CCI-779 determined to be the MTD in Part I. At least 3 patients are entered at each dose level in part II. | |||
Study Arms ICMJE | Not Provided | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 15 | |||
Original Enrollment ICMJE | Not Provided | |||
Actual Study Completion Date ICMJE | June 2002 | |||
Actual Primary Completion Date | June 2002 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS: Part I:
Part II:
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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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00003712 | |||
Other Study ID Numbers ICMJE | CDR0000066820 P30CA054174 ( U.S. NIH Grant/Contract ) UTHSC-9785011303 ( Other Identifier: UTHSCSA IRB ) SACI-IDD-98-02 ( Other Identifier: San Antonio Cancer Institute ) W-AR-3066K1-100-US ( Other Identifier: Wyeth ) NCI-V98-1506 ( Other Identifier: NCI ) | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | The University of Texas Health Science Center at San Antonio | |||
Study Sponsor ICMJE | The University of Texas Health Science Center at San Antonio | |||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | The University of Texas Health Science Center at San Antonio | |||
Verification Date | August 2012 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |