Spots Global Cancer Trial Database for Bortezomib and Gemcitabine in Treating Older Patients With Advanced Solid Tumors
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Trial Identification
Brief Title: Bortezomib and Gemcitabine in Treating Older Patients With Advanced Solid Tumors
Official Title: Phase I Study of Bortezomib and Gemcitabine in Elderly Patients With Solid Tumors (X05227)
Study ID: NCT00620295
Study Description
Brief Summary: RATIONALE: Bortezomib may stop the growth of solid tumors by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bortezomib together with gemcitabine may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of bortezomib and gemcitabine in treating older patients with advanced solid tumors.
Detailed Description: OBJECTIVES: Primary * To determine the maximum tolerated dose of weekly bortezomib and gemcitabine in treating elderly patients with advanced solid tumors. Secondary * To characterize the quantitative and qualitative toxicities of bortezomib and gemcitabine in these patients. * To obtain preliminary information about the anti-tumor activity of bortezomib and gemcitabine. * To characterize gemcitabine and metabolite pharmacokinetics in patients receiving concurrent bortezomib therapy. OUTLINE: This is a phase I dose escalation study of bortezomib and gemcitabine. Patients receive gemcitabine intravenously (IV) over 30 minutes followed 1 hour later by bortezomib IV over 3-5 seconds on days 1 and 8. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of gemcitabine and bortezomib until the maximum tolerated dose of the combination is determined. Blood is collected periodically for pharmacokinetic and pharmacogenetic studies. After completion of study treatment, patients are followed every 3 months for up to 1 year.
Eligibility
Minimum Age: 70 Years
Eligible Ages: OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Masonic Cancer Center at University of Minnesota, Minneapolis, Minnesota, United States
Contact Details
Name: Arkadiusz Dudek, MD
Affiliation: Masonic Cancer Center, University of Minnesota
Role: PRINCIPAL_INVESTIGATOR
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