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Phase I/II Clinical Trial of Bortezomib (Velcade) + Pemetrexed (Alimta) in Previously Treated Patients With Advanced Non-Small Cell Lung Cancer

Phase 1/Phase 2
18 Years
Open (Enrolling)
Non-small Cell Lung Cancer

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Trial Information

Phase I/II Clinical Trial of Bortezomib (Velcade) + Pemetrexed (Alimta) in Previously Treated Patients With Advanced Non-Small Cell Lung Cancer

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

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

(Phase I)Maximum tolerated dose of bortezomib

Outcome Time Frame:

Within 6 three-week cycles (18 weeks)

Safety Issue:


Principal Investigator

Ronald B. Natale, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cedars-Sinai Outpatient Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

January 2006

Completion Date:

August 2012

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Comprehensive Cancer Center at Desert Regional Medical Center Palm Springs, California  92262
California Pacific Medical Center San Francisco, California  94115
Cedars-Sinai Outpatient Cancer Center Los Angeles, California  
Trinitas Comprehensive Cancer Center Elizabeth, New Jersey  07207