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

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ClinicalTrials.gov 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

August 10, 2007
August 14, 2007
January 15, 2010
January 2006
January 2010   (Final data collection date for primary outcome measure)
  • (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 ]
Same as current
Complete list of historical versions of study NCT00516100 on ClinicalTrials.gov Archive Site
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Bortezomib (Velcade) + Pemetrexed (Alimta) in Advanced NSCLC
Phase I/II Clinical Trial of Bortezomib (Velcade) + Pemetrexed (Alimta) in Previously Treated Patients With Advanced Non-Small Cell Lung Cancer
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.
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Phase 1
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Non-small Cell Lung Cancer
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)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Unknown status
August 2012
January 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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Marti McKinley, Aptium Oncology Research Network
Aptium Oncology Research Network
Millennium Pharmaceuticals, Inc.
Principal Investigator: Ronald B. Natale, MD Cedars-Sinai Outpatient Cancer Center
Aptium Oncology Research Network
January 2010

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