Temsirolimus and Vinorelbine Ditartrate in Treating Patients With Unresectable or Metastatic Solid Tumors
NCT01155258
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Descriptive Information | ||||
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Brief Title ICMJE | Temsirolimus and Vinorelbine Ditartrate in Treating Patients With Unresectable or Metastatic Solid Tumors | |||
Official Title ICMJE | Phase I Clinical Trial of Temsirolimus and Vinorelbine in Advanced Solid Tumors. | |||
Brief Summary | RATIONALE: Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as vinorelbine ditartrate, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving temsirolimus together with vinorelbine ditartrate may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of giving temsirolimus and vinorelbine ditartrate together in treating patients with unresectable or metastatic solid tumors. | |||
Detailed Description | PRIMARY OBJECTIVES: I. To determine the maximal tolerated dose (MTD) for the combination of temsirolimus and vinorelbine in advanced solid tumors. II. To obtain preliminary information regarding the activity of this combination. SECONDARY OBJECTIVES: I. To evaluate the safety and tolerability of this combination. OUTLINE: Patients receive temsirolimus IV over 30-60 minutes on days 1, 8, 15, and 22 and vinorelbine ditartrate IV over 5-10 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. | |||
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 |
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Study Arms ICMJE | Experimental: Arm I
Patients receive temsirolimus IV over 30-60 minutes on days 1, 8, 15, and 22 and vinorelbine ditartrate IV over 5-10 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Interventions:
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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 | 19 | |||
Original Estimated Enrollment ICMJE | 20 | |||
Actual Study Completion Date ICMJE | May 2014 | |||
Actual Primary Completion Date | January 2013 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion
Exclusion
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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 | NCT01155258 | |||
Other Study ID Numbers ICMJE | 0C-09-6 NCI-2010-01382 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | University of Southern California | |||
Study Sponsor ICMJE | University of Southern California | |||
Collaborators ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Investigators ICMJE |
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PRS Account | University of Southern California | |||
Verification Date | June 2016 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |