Bortezomib and Gemcitabine in Treating Patients With Relapsed Mantle Cell Lymphoma

This study has been completed.
Sponsor:
Information provided by:
NCIC Clinical Trials Group
ClinicalTrials.gov Identifier:
NCT00377052
First received: September 13, 2006
Last updated: June 21, 2011
Last verified: June 2011
  Purpose

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 Intervention Phase
Lymphoma
Drug: bortezomib
Drug: gemcitabine hydrochloride
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Bortezomib and Gemcitabine in Patients With Relapsed Mantle Cell Lymphoma

Resource links provided by NLM:


Further study details as provided by NCIC Clinical Trials Group:

Primary Outcome Measures:
  • Objective tumor response (overall response rate with 95% confidence interval) [ Time Frame: each cycle ] [ Designated as safety issue: No ]
  • Time to progression at median time [ Time Frame: each cycle and every 3 months after treatment ] [ Designated as safety issue: No ]
  • Duration of response (median and range) [ Time Frame: each cycle and every 3 months after treatment ] [ Designated as safety issue: No ]
  • Rate of stable disease and progressive disease [ Time Frame: each cycle and every 3 months after treatment ] [ Designated as safety issue: No ]

Enrollment: 29
Study Start Date: June 2006
Study Completion Date: June 2011
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: bortezomib
    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
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00377052

Locations
Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
BCCA - Vancouver Cancer Centre
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Manitoba
CancerCare Manitoba
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
Canada, Ontario
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
Canada, Quebec
McGill University - Dept. Oncology
Montreal, Quebec, Canada, H2W 1S6
Canada, Saskatchewan
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, Canada, S7N 4H4
Sponsors and Collaborators
NCIC Clinical Trials Group
Investigators
Principal Investigator: C. Tom Kouroukis, MD Margaret and Charles Juravinski Cancer Centre
  More Information

Additional Information:
No publications provided

Responsible Party: Ralph Meyer, M.D., NCIC Clinical Trials Group
ClinicalTrials.gov Identifier: NCT00377052     History of Changes
Other Study ID Numbers: I172, CAN-NCIC-IND172, ORTHO-CAN-NCIC-IND172, CDR0000493021
Study First Received: September 13, 2006
Last Updated: June 21, 2011
Health Authority: Canada: Health Canada

Keywords provided by NCIC Clinical Trials Group:
recurrent mantle cell lymphoma

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Mantle-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Gemcitabine
Bortezomib
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on September 18, 2014