Bortezomib and Gemcitabine in Treating Patients With Relapsed Mantle Cell Lymphoma

NCT ID: NCT00377052

Last Updated: 2023-08-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-16
• Study Completion Date: 2011-06-21

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.

Conditions

Lymphoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Bortezomib + Gemcitabine

Group Type: EXPERIMENTAL

bortezomib

Intervention Type: DRUG

1.0 mg/m2 IV; injection bolus (3-5 sec) Twice weekly x 2 weeks every three weeks

gemcitabine hydrochloride

Intervention Type: DRUG

1000 mg/m2 IV; injection 30 minute infusion Once weekly x 2 weeks every three weeks

Interventions

bortezomib

1.0 mg/m2 IV; injection bolus (3-5 sec) Twice weekly x 2 weeks every three weeks

Intervention Type: DRUG

gemcitabine hydrochloride

1000 mg/m2 IV; injection 30 minute infusion Once weekly x 2 weeks every three weeks

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed mantle cell lymphoma

• Relapsed disease
• Not refractory to prior therapy

• Must have received 1-3 prior systemic chemotherapy regimens AND has had no disease progression while receiving chemotherapy or within 1 month of last dose of most recent therapy
• Clinically and/or radiologically documented disease

• At least 1 site of disease must be bidimensionally measurable by CT scan or MRI with ≥ 1 lesion meeting 1 of the following criteria:

• Lymph nodes ≥ 1.5 cm x 1.5 cm by spiral CT scan
• Non-nodal lesion ≥ 1 cm x 1 cm by MRI, CT scan, or physical exam
• No nonmeasurable disease only
• No preexisting ascites or pleural effusion ≥ grade 2
• No known CNS involvement by lymphoma

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2
• Life expectancy ≥ 12 weeks
• Absolute granulocyte count ≥ 1,500/mm³
• Platelet count ≥ 75,000/mm³
• Creatinine ≤ 1.5 times upper limit of normal (ULN)
• Bilirubin ≤ 1.5 times ULN
• AST or ALT ≤ 2.5 times ULN
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• LVEF ≥ 45% by echocardiogram or MUGA
• No history of allergic reactions attributed to compounds containing boron or mannitol
• No preexisting edema ≥ grade 2
• No preexisting neuropathy (sensory and/or pain) ≥ grade 2
• No preexisting shortness of breath ≥ grade 2
• No history of other malignancies, except adequately treated nonmelanoma skin cancer, curatively treated in situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for ≥ 5 years
• No other serious illness or medical condition that would preclude compliance with study requirements, including any of the following:

• Serious uncontrolled infection
• Uncontrolled or severe cardiovascular disease, including any of the following:

• Myocardial infarction within the past 6 months
• New York Heart Association class III-IV heart failure
• Uncontrolled angina
• Clinically significant pericardial disease
• Cardiac amyloidosis
• Significant neurological disorder

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• At least 6 weeks since prior chemotherapy
• No prior radioactive monoclonal antibody therapy
• No prior bortezomib
• No prior investigational therapy (except for flavopiridol)
• No prior radiotherapy to > 25% of functioning bone marrow
• At least 4 weeks since prior radiotherapy and recovered

• Low-dose, nonmyelosuppressive radiotherapy may be allowed
• At least 2 weeks since prior major surgery
• No other concurrent anticancer therapy
• No concurrent corticosteroids
• No other concurrent cytotoxic chemotherapy
• No other concurrent investigational agents

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NCIC Clinical Trials Group

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

C. Tom Kouroukis, MD

Role: PRINCIPAL_INVESTIGATOR

Margaret and Charles Juravinski Cancer Centre

Locations

Cross Cancer Institute

Edmonton, Alberta, Canada

BCCA - Vancouver Cancer Centre

Vancouver, British Columbia, Canada

CancerCare Manitoba

Winnipeg, Manitoba, Canada

QEII Health Sciences Center

Halifax, Nova Scotia, Canada

QEII, CCR, Hematology Research

Halifax, Nova Scotia, Canada

Juravinski Cancer Centre at Hamilton Health Sciences

Hamilton, Ontario, Canada

London Regional Cancer Program

London, Ontario, Canada

Odette Cancer Centre

Toronto, Ontario, Canada

Univ. Health Network-Princess Margaret Hospital

Toronto, Ontario, Canada

McGill University - Dept. Oncology

Montreal, Quebec, Canada

Saskatoon Cancer Centre

Saskatoon, Saskatchewan, Canada

Countries

Canada

References

Kouroukis CT, Fernandez LA, Crump M, Gascoyne RD, Chua NS, Buckstein R, Turner R, Assouline S, Klasa RJ, Walsh W, Powers J, Eisenhauer E. A phase II study of bortezomib and gemcitabine in relapsed mantle cell lymphoma from the National Cancer Institute of Canada Clinical Trials Group (IND 172). Leuk Lymphoma. 2011 Mar;52(3):394-9. doi: 10.3109/10428194.2010.546015.

Reference Type: RESULT

PMID: 21323520 (View on PubMed)

Other Identifiers

CAN-NCIC-IND172

Identifier Type: REGISTRY

Identifier Source: secondary_id

ORTHO-CAN-NCIC-IND172

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000493021

Identifier Type: OTHER

Identifier Source: secondary_id

B9E-CA-0485

Identifier Type: OTHER

Identifier Source: secondary_id

I172

Identifier Type: -

Identifier Source: org_study_id