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LymphomaPhase 2NCT00377052

Bortezomib and Gemcitabine in Treating Patients With Relapsed Mantle Cell Lymphoma

A Phase 2 study testing bortezomib and gemcitabine hydrochloride in people with Lymphoma, run by NCIC Clinical Trials Group at 11 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 120 years
Conditions the study is for
Lymphoma
What is being tested?
bortezomib and gemcitabine hydrochloride
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
11 sitesCanada
Study dates
16 Jan 2007to 21 Jun 2011
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

Canada11 sites

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • QEII Health Sciences Center

    Halifax, Nova Scotia, B3H 1V7

  • QEII, CCR, Hematology Research

    Halifax, Nova Scotia, B3H 1V7

  • Juravinski Cancer Centre at Hamilton Health Sciences

    Hamilton, Ontario, L8V 5C2

  • London Regional Cancer Program

    London, Ontario, N6A 4L6

  • McGill University - Dept. Oncology

    Montreal, Quebec, H2W 1S6

  • Saskatoon Cancer Centre

    Saskatoon, Saskatchewan, S7N 4H4

  • Odette Cancer Centre

    Toronto, Ontario, M4N 3M5

  • Univ. Health Network-Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

  • BCCA - Vancouver Cancer Centre

    Vancouver, British Columbia, V5Z 4E6

  • CancerCare Manitoba

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

About this study

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

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.

Read the 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
Keywords
recurrent mantle cell lymphoma
Medical subject headings
Lymphoma, Lymphoma, Mantle-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • bortezomibDrug

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

  • gemcitabine hydrochlorideDrug

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

Study groups in NCT00377052
Study groupRoleWhat they receive
Bortezomib + GemcitabineExperimentalNot described
Receives: Drug: bortezomib; Drug: gemcitabine hydrochloride

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective tumor response (overall response rate with 95% confidence interval)

    Measured: each cycle

  2. Time to progression at median time

    Measured: each cycle and every 3 months after treatment

  3. Duration of response (median and range)

    Measured: each cycle and every 3 months after treatment

  4. Rate of stable disease and progressive disease

    Measured: each cycle and every 3 months after treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Sep 2006 (estimated)
  2. Study start16 Jan 2007
  3. Primary completion21 Apr 2009
  4. Study completion21 Jun 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00377052
Sponsor's protocol ID
I172
Other IDs
CAN-NCIC-IND172, ORTHO-CAN-NCIC-IND172, CDR0000493021, B9E-CA-0485
Status last verified
Apr 2020
First submitted
13 Sep 2006
Last updated
4 Aug 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 21323520

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing bortezomib and gemcitabine hydrochloride in people with Lymphoma, run by NCIC Clinical Trials Group at 11 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective tumor response (overall response rate with 95% confidence interval) (time frame: each cycle). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00377052, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2023.

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