Bortezomib and Gemcitabine in Treating Patients With Relapsed Mantle Cell Lymphoma

NCT00377052 | Completed Phase 2 DMC

• 5 other identifiers: I172CAN-NCIC-IND172ORTHO-CAN-NCIC-IND172CDR0000493021B9E-CA-0485
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 11

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.

Conditions

Lymphoma

Keywords

recurrent mantle cell lymphoma

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

Bortezomib + Gemcitabine

EXPERIMENTAL

Drug: bortezomib; Drug: gemcitabine hydrochloride

Interventions

bortezomib DRUG

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

Bortezomib + Gemcitabine

gemcitabine hydrochloride DRUG

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

Bortezomib + Gemcitabine

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• NCIC Clinical Trials Group: lead

Study Sites (11)

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

BCCA - Vancouver Cancer Centre

Vancouver, British Columbia, V5Z 4E6, Canada

Location

CancerCare Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada

Location

QEII Health Sciences Center

Halifax, Nova Scotia, B3H 1V7, Canada

Location

QEII, CCR, Hematology Research

Halifax, Nova Scotia, B3H 1V7, Canada

Location

Juravinski Cancer Centre at Hamilton Health Sciences

Hamilton, Ontario, L8V 5C2, Canada

Location

London Regional Cancer Program

London, Ontario, N6A 4L6, Canada

Location

Odette Cancer Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Univ. Health Network-Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

McGill University - Dept. Oncology

Montreal, Quebec, H2W 1S6, Canada

Location

Saskatoon Cancer Centre

Saskatoon, Saskatchewan, S7N 4H4, Canada

Location

Related Publications (1)

• 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.

  PMID: 21323520 RESULT

MeSH Terms

Conditions

Lymphoma; Lymphoma, Mantle-Cell

Interventions

Bortezomib; Gemcitabine

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, Non-Hodgkin

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines

Study Officials

• C. Tom Kouroukis, MD

  Margaret and Charles Juravinski Cancer Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2006
• First Posted: September 15, 2006
• Study Start: January 16, 2007
• Primary Completion: April 21, 2009
• Study Completion: June 21, 2011
• Last Updated: August 4, 2023

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (11)