Bortezomib and Gemcitabine in Treating Patients With Relapsed Mantle Cell Lymphoma
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|ClinicalTrials.gov Identifier: NCT00377052|
Recruitment Status : Completed
First Posted : September 15, 2006
Last Update Posted : April 8, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Drug: bortezomib Drug: gemcitabine hydrochloride||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||29 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Bortezomib and Gemcitabine in Patients With Relapsed Mantle Cell Lymphoma|
|Actual Study Start Date :||June 14, 2006|
|Actual Primary Completion Date :||April 21, 2009|
|Actual Study Completion Date :||June 21, 2011|
|Experimental: Bortezomib + Gemcitabine||
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
- Objective tumor response (overall response rate with 95% confidence interval) [ Time Frame: each cycle ]
- Time to progression at median time [ Time Frame: each cycle and every 3 months after treatment ]
- Duration of response (median and range) [ Time Frame: each cycle and every 3 months after treatment ]
- Rate of stable disease and progressive disease [ Time Frame: each cycle and every 3 months after treatment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00377052
|Cross Cancer Institute|
|Edmonton, Alberta, Canada, T6G 1Z2|
|Canada, British Columbia|
|BCCA - Vancouver Cancer Centre|
|Vancouver, British Columbia, Canada, V5Z 4E6|
|Winnipeg, Manitoba, Canada, R3E 0V9|
|Canada, Nova Scotia|
|QEII Health Sciences Center|
|Halifax, Nova Scotia, Canada, B3H 1V7|
|QEII, CCR, Hematology Research|
|Halifax, Nova Scotia, Canada, B3H 1V7|
|Juravinski Cancer Centre at Hamilton Health Sciences|
|Hamilton, Ontario, Canada, L8V 5C2|
|London Regional Cancer Program|
|London, Ontario, Canada, N6A 4L6|
|Odette Cancer Centre|
|Toronto, Ontario, Canada, M4N 3M5|
|Univ. Health Network-Princess Margaret Hospital|
|Toronto, Ontario, Canada, M5G 2M9|
|McGill University - Dept. Oncology|
|Montreal, Quebec, Canada, H2W 1S6|
|Saskatoon Cancer Centre|
|Saskatoon, Saskatchewan, Canada, S7N 4H4|
|Principal Investigator:||C. Tom Kouroukis, MD||Margaret and Charles Juravinski Cancer Centre|