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Bortezomib With or Without Docetaxel in Treating Patients With Relapsed or Refractory Advanced Non-Small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00064012
Recruitment Status : Completed
First Posted : July 9, 2003
Last Update Posted : December 13, 2019
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Wisconsin, Madison

Brief Summary:

RATIONALE: Drugs used in chemotherapy such as docetaxel use different ways to stop tumor cells from dividing so they stop growing or die. Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. It is not yet known whether bortezomib is more effective with or without docetaxel in treating patients with advanced non-small cell lung cancer.

PURPOSE: Randomized phase II trial to compare the effectiveness of bortezomib with or without docetaxel in treating patients who have relapsed or refractory stage IIIB or stage IV non-small cell lung cancer.

Condition or disease Intervention/treatment Phase
Lung Cancer Drug: bortezomib Drug: docetaxel Phase 2

Detailed Description:



  • Compare the tumor response rates (complete and partial response) in patients with relapsed or refractory advanced non-small cell lung cancer treated with bortezomib with vs without docetaxel.


  • Compare time to progression in patients treated with these regimens.
  • Compare the overall and 1-year survival of patients treated with these regimens.
  • Compare the safety and tolerability of these regimens in these patients.
  • Compare the pharmacokinetics and pharmacodynamics of these regimens in these patients.
  • Compare the quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11.
  • Arm II: Patients receive docetaxel IV over 1 hour on day 1 and bortezomib IV as in arm I.

In both arms, courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients achieving complete response (CR) receive 2 additional courses beyond confirmation of CR.

Quality of life is assessed on day 1 of each treatment course (before drug administration) and at 30 days after the completion of study treatment.

Patients are followed at 30 days and then every 3 months for survival.

PROJECTED ACCRUAL: A total of 155 patients (75 for arm I and 80 for arm II) will be accrued for this study within 1 year.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Multicenter, Open-Label, Phase II Study Of VELCADE Alone Or VELCADE Plus Docetaxel In Previously Treated Patients With Advanced Non-Small Cell Lung Cancer
Study Start Date : May 2003
Actual Primary Completion Date : July 2004
Actual Study Completion Date : July 2004

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Velcade Alone
Drug: bortezomib
Experimental: Velcade plus Docetaxel
Velcade plus Docetaxel
Drug: bortezomib
Drug: docetaxel

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically or cytologically confirmed non-small cell lung cancer

    • Locally advanced (stage IIIB) or metastatic (stage IV) disease
    • Inoperable disease
  • Relapsed or refractory disease

    • Received 1, and only 1, prior chemotherapy regimen for locally advanced or metastatic disease
  • Measurable or evaluable disease
  • No symptomatic or inadequately treated brain metastases
  • No CNS disease



  • 18 and over

Performance status

  • Karnofsky 70-100%

Life expectancy

  • More than 3 months


  • Platelet count greater than 100,000/mm^3
  • Hemoglobin greater than 8.0 g/dL
  • Absolute neutrophil count greater than 1,500/mm^3


  • AST and ALT less than 3 times upper limit of normal (ULN)
  • Bilirubin less than 1.5 times ULN
  • Hepatitis B surface antigen negative
  • Hepatitis C negative


  • Creatinine less than 1.8 mg/dL


  • No myocardial infarction within the past 6 months
  • No New York Heart Association class III or IV heart failure
  • No uncontrolled angina
  • No severe uncontrolled ventricular arrhythmias
  • No electrocardiographic evidence of acute ischemia or active conduction system abnormalities
  • No poorly controlled hypertension


  • No active systemic infection requiring treatment
  • No prior allergic reaction attributable to compounds containing boron or mannitol
  • HIV negative


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective barrier contraception
  • No peripheral neuropathy grade 2 or greater
  • No diabetes mellitus
  • No other serious medical or psychiatric condition that would preclude study participation


Biologic therapy

  • More than 6 weeks since prior monoclonal antibody therapy
  • No concurrent routine use of colony-stimulating factors (e.g., filgrastim [G-CSF] or sargramostim [GM-CSF])
  • No concurrent immunotherapy


  • See Disease Characteristics
  • More than 4 weeks since prior chemotherapy
  • No prior docetaxel

    • Prior paclitaxel allowed
  • No other concurrent chemotherapy

Endocrine therapy

  • No concurrent corticosteroids (e.g., prednisone or prednisolone) except dexamethasone as premedication


  • More than 4 weeks since prior radiotherapy
  • No concurrent radiotherapy


  • More than 4 weeks since prior major surgery
  • No concurrent surgery for cancer management or treatment


  • More than 5 years since prior treatment for any other cancer except basal cell skin cancer or carcinoma in situ of the cervix
  • More than 4 weeks since prior investigational agents
  • No prior bortezomib
  • No other concurrent investigational agents
  • No other concurrent clinical research study participation
  • No other concurrent antineoplastic therapy
  • No concurrent routine use of anti-inflammatory drugs, including cyclo-oxygenase inhibitors (e.g., celecoxib or rofecoxib)

Information from the National Library of Medicine

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 identifier (NCT number): NCT00064012

Show Show 21 study locations
Sponsors and Collaborators
University of Wisconsin, Madison
National Cancer Institute (NCI)
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Principal Investigator: Joan H. Schiller, MD University of Wisconsin, Madison
Publications of Results:
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Responsible Party: University of Wisconsin, Madison Identifier: NCT00064012    
Other Study ID Numbers: CDR0000305974
P30CA016042 ( U.S. NIH Grant/Contract )
First Posted: July 9, 2003    Key Record Dates
Last Update Posted: December 13, 2019
Last Verified: March 2013
Keywords provided by University of Wisconsin, Madison:
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
recurrent non-small cell lung cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action