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

January 14, 2010 updated by: Aptium Oncology Research Network

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.

Study Overview

Status

Unknown

Conditions

Non-small Cell Lung Cancer

Intervention / Treatment

Drug: bortezomib

Study Type

Interventional

Enrollment (Anticipated)

Phase

Phase 2
Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- California
  - Los Angeles, California, United States, 90048
    - Cedars-Sinai Outpatient Cancer Center
  - Palm Springs, California, United States, 92262
    - Comprehensive Cancer Center at Desert Regional Medical Center
  - San Francisco, California, United States, 94115
    - California Pacific Medical Center
- New Jersey
  - Elizabeth, New Jersey, United States, 07207
    - Trinitas Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
(Phase I)Maximum tolerated dose of bortezomib Time Frame: Within 6 three-week cycles (18 weeks)	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	one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aptium Oncology Research Network

Collaborators

Millennium Pharmaceuticals, Inc.

Investigators

Principal Investigator: Ronald B. Natale, MD, Cedars-Sinai Outpatient Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Anticipated)

January 1, 2010

Study Completion (Anticipated)

August 1, 2012

Study Registration Dates

First Submitted

August 10, 2007

First Submitted That Met QC Criteria

August 13, 2007

First Posted (Estimate)

August 14, 2007

Study Record Updates

Last Update Posted (Estimate)

January 15, 2010

Last Update Submitted That Met QC Criteria

January 14, 2010

Last Verified