Clinical trial NCT00516100: Bortezomib (Velcade) + Pemetrexed (Alimta) in Advanced NSCLC
Official title: Phase I/II Clinical Trial of Bortezomib (Velcade) + Pemetrexed (Alimta) in Previously Treated Patients With Advanced Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Non-small Cell Lung Cancer
Keywords: NSCLC
Lead sponsor: Aptium Oncology Research Network
Sponsor class: NETWORK
Collaborators: name: Millennium Pharmaceuticals, Inc.
First posted: 2007-08-14
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: (Phase I)Maximum tolerated dose of bortezomib
timeFrame: Within 6 three-week cycles (18 weeks)
measure: (Phase II)determine response rate, time to progression, one-year survival, and overall survival rates
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Outpatient Cancer Center
state: California
city: Palm Springs
country: United States
facility: Comprehensive Cancer Center at Desert Regional Medical Center
state: California
city: San Francisco
country: United States
facility: California Pacific Medical Center
state: California
city: Elizabeth
country: United States
facility: Trinitas Comprehensive Cancer Center
state: New Jersey
Study officials:
affiliation: Cedars-Sinai Outpatient Cancer Center
name: Ronald B. Natale, MD
role: PRINCIPAL_INVESTIGATOR
References: