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Bortezomib (Velcade) + Pemetrexed (Alimta) in Advanced NSCLC

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: NCT00516100
Recruitment Status : Unknown
Verified January 2010 by Aptium Oncology Research Network.
Recruitment status was:  Active, not recruiting
First Posted : August 14, 2007
Last Update Posted : January 15, 2010
Millennium Pharmaceuticals, Inc.
Information provided by:
Aptium Oncology Research Network

Brief Summary:
Pemetrexed is an FDA-approved treatment for advanced lung cancer but the response rate is still very low. Bortezomib is currently approved to treat myeloma in patients who have already been treated. Currently, multiple studies are actively investigating how well bortezomib works with other drugs. This study is testing how much bortezomib can be given to advanced lung cancer patients who have already received one treatment. This study will also see how well bortezomib and pemetrexed work together to treat lung cancer patients.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Drug: bortezomib Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 62 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/II Clinical Trial of Bortezomib (Velcade) + Pemetrexed (Alimta) in Previously Treated Patients With Advanced Non-Small Cell Lung Cancer
Study Start Date : January 2006
Estimated Primary Completion Date : January 2010
Estimated Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Intervention Details:
  • Drug: bortezomib
    MTD of bortezomib administered Days 1 and 8 plus 500 mg/m2 pemetrexed on day 1, every three weeks.
    Other Names:
    • Velcade (bortezomib)
    • Alimta (pemetrexed)

Primary Outcome Measures :
  1. (Phase I)Maximum tolerated dose of bortezomib [ Time Frame: Within 6 three-week cycles (18 weeks) ]
  2. (Phase II)determine response rate, time to progression, one-year survival, and overall survival rates [ Time Frame: one year ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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

Inclusion Criteria:

  • Unresectable locally advanced (Stage IIIB) or metastatic (Stage IV) NSCLC who have received one prior platinum-based chemotherapy regimen.
  • One prior treatment with any biologically targeted agent is acceptable
  • Stable, previously treated, brain metastases are allowed if clinically stable without steroid treatment for 10 days.
  • ECOG performance status of 0 or 1.
  • Measurable and/or evaluable indicator lesion(s).
  • Adequate hematologic, renal and hepatic function
  • Patient is of a legally consenting age
  • Patient has a life-expectancy >2 months.
  • Voluntary written informed consent before performance of any study-related procedure
  • Female patient is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control for the duration of the study.
  • Male patient agrees to use an acceptable method for contraception for the duration of the study.

Exclusion Criteria:

  • Prior treatment with pemetrexed (Alimta) or Bortezomib (Velcade).
  • Patient was treated for another cancer within 3 years before enrollment, with the exception of basal cell carcinoma or cervical cancer in situ.
  • Peripheral neuropathy NCI grade > 2.
  • Symptomatic or uncontrolled brain metastasis.
  • Radiation therapy to major bone marrow (> 10% of bone marrow) areas or to target lesions within 30 days prior to study entry.
  • Patient has received other investigational drugs with 14 days before enrollment.
  • Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
  • Any systemic therapy within 21 days prior to study entry.
  • Patient known to be human immunodeficiency virus (HIV)-positive.
  • Patient had a significant cardiac event within 6 months of enrollment
  • History of arrhythmia
  • Congenital long QT syndrome or 1st degree relative with unexplained sudden death under 40 years of age.
  • QT prolongation with other medications that required discontinuation of that medication.
  • Presence of left bundle branch block (LBBB).
  • QTc ≥480 msec or greater on screening ECG.
  • Patient has hypersensitivity to bortezomib, boron or mannitol.
  • Female patient is pregnant or breast-feeding.

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): NCT00516100

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United States, California
Cedars-Sinai Outpatient Cancer Center
Los Angeles, California, United States, 90048
Comprehensive Cancer Center at Desert Regional Medical Center
Palm Springs, California, United States, 92262
California Pacific Medical Center
San Francisco, California, United States, 94115
United States, New Jersey
Trinitas Comprehensive Cancer Center
Elizabeth, New Jersey, United States, 07207
Sponsors and Collaborators
Aptium Oncology Research Network
Millennium Pharmaceuticals, Inc.
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Principal Investigator: Ronald B. Natale, MD Cedars-Sinai Outpatient Cancer Center
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Responsible Party: Marti McKinley, Aptium Oncology Research Network Identifier: NCT00516100    
Other Study ID Numbers: 05LUN01
First Posted: August 14, 2007    Key Record Dates
Last Update Posted: January 15, 2010
Last Verified: January 2010
Keywords provided by Aptium Oncology Research Network:
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
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors