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Spots Global Cancer Trial Database for Temsirolimus and Vinorelbine Ditartrate in Treating Patients With Unresectable or Metastatic Solid Tumors

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Trial Identification

Brief Title: Temsirolimus and Vinorelbine Ditartrate in Treating Patients With Unresectable or Metastatic Solid Tumors

Official Title: Phase I Clinical Trial of Temsirolimus and Vinorelbine in Advanced Solid Tumors.

Study ID: NCT01155258

Study Description

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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

USC/Norris Comprehensive Cancer Center, Los Angeles, California, United States

Contact Details

Name: Agustin Garcia

Affiliation: University of Southern California

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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