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