NCT00620295

Bortezomib and Gemcitabine in Treating Older Patients With Advanced Solid Tumors

Phase I Study of Bortezomib and Gemcitabine in Elderly Patients With Solid Tumors (X05227)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Masonic Cancer Center, University of Minnesota · Academic / Other
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer
• Colorectal Cancer
• Head and Neck Cancer
• Kidney Cancer
• Lung Cancer
• Ovarian Cancer
• Pancreatic Cancer
• Prostate Cancer
• Sarcoma

Interventions

Type	Name	Description
DRUG	bortezomib	Bortezomib will be given 1 hour after gemcitabine by intravenous pyelogram (IVP) over 3 to 5 seconds followed by a standard saline flush or through a running intravenous (IV) line at the patient's assigned dose (1.0 up to 1.8 mg/m\^2) on days 1 and 8 of a 21 day treatment cycle until disease progression or for a maximum of 6 cycles.
DRUG	gemcitabine hydrochloride	Gemcitabine will be administered as a 30 minute intravenous infusion at the patient's assigned dose (800 up to 1000 mg/m\^2) on day 1 and day 8 of a 21 day cycle.

Timeline

• Start date: 2007-03-01
• Primary completion: 2009-02-01
• Completion: 2009-10-01
• First posted: 2008-02-21
• Last updated: 2017-11-29

Locations

1 site across 1 country: United States