- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00516100
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
Study Type
Interventional
Enrollment (Anticipated)
62
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
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California
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Los Angeles, California, United States, 90048
- Cedars-Sinai Outpatient Cancer Center
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Palm Springs, California, United States, 92262
- Comprehensive Cancer Center at Desert Regional Medical Center
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San Francisco, California, United States, 94115
- California Pacific Medical Center
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New Jersey
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Elizabeth, New Jersey, United States, 07207
- Trinitas Comprehensive Cancer Center
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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
No
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)
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Within 6 three-week cycles (18 weeks)
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(Phase II)determine response rate, time to progression, one-year survival, and overall survival rates
Time Frame: one year
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one year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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
January 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Molecular Mechanisms of Pharmacological Action
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Antineoplastic Agents
- Folic Acid Antagonists
- Bortezomib
- Pemetrexed
Other Study ID Numbers
- 05LUN01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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