Bortezomib and Gemcitabine in Treating Patients With Relapsed Mantle Cell Lymphoma
- Registration Number
- NCT00377052
- Lead Sponsor
- NCIC Clinical Trials Group
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 29
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Bortezomib + Gemcitabine gemcitabine hydrochloride - Bortezomib + Gemcitabine bortezomib -
- Primary Outcome Measures
Name Time Method Objective tumor response (overall response rate with 95% confidence interval) each cycle Time to progression at median time each cycle and every 3 months after treatment Duration of response (median and range) each cycle and every 3 months after treatment Rate of stable disease and progressive disease each cycle and every 3 months after treatment
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (11)
London Regional Cancer Program
🇨🇦London, Ontario, Canada
Saskatoon Cancer Centre
🇨🇦Saskatoon, Saskatchewan, Canada
Odette Cancer Centre
🇨🇦Toronto, Ontario, Canada
CancerCare Manitoba
🇨🇦Winnipeg, Manitoba, Canada
Univ. Health Network-Princess Margaret Hospital
🇨🇦Toronto, Ontario, Canada
Cross Cancer Institute
🇨🇦Edmonton, Alberta, Canada
BCCA - Vancouver Cancer Centre
🇨🇦Vancouver, British Columbia, Canada
Juravinski Cancer Centre at Hamilton Health Sciences
🇨🇦Hamilton, Ontario, Canada
QEII Health Sciences Center
🇨🇦Halifax, Nova Scotia, Canada
McGill University - Dept. Oncology
🇨🇦Montreal, Quebec, Canada
QEII, CCR, Hematology Research
🇨🇦Halifax, Nova Scotia, Canada