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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

Tracking Information
First Submitted Date  ICMJE August 10, 2007
First Posted Date  ICMJE August 14, 2007
Last Update Posted Date January 15, 2010
Study Start Date  ICMJE January 2006
Estimated Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 13, 2007)
  • (Phase I)Maximum tolerated dose of bortezomib [ Time Frame: Within 6 three-week cycles (18 weeks) ]
  • (Phase II)determine response rate, time to progression, one-year survival, and overall survival rates [ Time Frame: one year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Bortezomib (Velcade) + Pemetrexed (Alimta) in Advanced NSCLC
Official Title  ICMJE Phase I/II Clinical Trial of Bortezomib (Velcade) + Pemetrexed (Alimta) in Previously Treated Patients With Advanced Non-Small Cell Lung Cancer
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Non-small Cell Lung Cancer
Intervention  ICMJE 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)
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 13, 2007)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2012
Estimated Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00516100
Other Study ID Numbers  ICMJE 05LUN01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Marti McKinley, Aptium Oncology Research Network
Study Sponsor  ICMJE Aptium Oncology Research Network
Collaborators  ICMJE Millennium Pharmaceuticals, Inc.
Investigators  ICMJE
Principal Investigator: Ronald B. Natale, MD Cedars-Sinai Outpatient Cancer Center
PRS Account Aptium Oncology Research Network
Verification Date January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP