NCT00377052

Bortezomib and Gemcitabine in Treating Patients With Relapsed Mantle Cell Lymphoma

A Phase II Study of Bortezomib and Gemcitabine in Patients With Relapsed Mantle Cell Lymphoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: NCIC Clinical Trials Group · Network
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Bortezomib may help gemcitabine work better by making cancer cells more sensitive to the drug. PURPOSE: This phase II trial is studying how well giving bortezomib together with gemcitabine works in treating patients with relapsed mantle cell lymphoma.

Detailed description

OBJECTIVES: * Determine the efficacy (response rate) of bortezomib and gemcitabine hydrochloride in patients with relapsed mantle cell lymphoma. * Determine the toxicity of this regimen in these patients. * Determine the time to progression and duration of response in patients treated with this regimen. OUTLINE: This is a nonrandomized, multicenter study. Patients receive bortezomib IV on days 1, 4, 8, and 11 and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 4 weeks and then every 3 months thereafter until relapse/progression.

Conditions

• Lymphoma

Interventions

Type	Name	Description
DRUG	bortezomib	1.0 mg/m2 IV; injection bolus (3-5 sec) Twice weekly x 2 weeks every three weeks
DRUG	gemcitabine hydrochloride	1000 mg/m2 IV; injection 30 minute infusion Once weekly x 2 weeks every three weeks

Timeline

• Start date: 2007-01-16
• Primary completion: 2009-04-21
• Completion: 2011-06-21
• First posted: 2006-09-15
• Last updated: 2023-08-04

Locations

11 sites across 1 country: Canada