Trial of Motexafin Gadolinium and Pemetrexed (Alimta®) for Second Line Treatment in Patients With Non-Small Cell Lung Cancer
NCT ID: NCT00365183
Last Updated: 2013-10-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
74 participants
INTERVENTIONAL
2006-06-30
2008-06-30
Brief Summary
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* to determine if the combination of two drugs, motexafin gadolinium and pemetrexed, may be an effective treatment for patients with non-small cell lung cancer (NSCLC) who have had one previous chemotherapy regimen that included a platinum containing drug such as cisplatin or carboplatin.
* to assess response to treatment in patients with NSCLC six months after beginning study treatment.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Xcytrin® (motexafin gadolinium)
Motexafin gadolinium and pemetrexed
1 dose of MGd 15 mg/kg and pemetrexed 500 mg/m2 once during the first week of every 3-week treatment cycle for a maximum of 12 cycles
Interventions
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Motexafin gadolinium and pemetrexed
1 dose of MGd 15 mg/kg and pemetrexed 500 mg/m2 once during the first week of every 3-week treatment cycle for a maximum of 12 cycles
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Stage IIIb, metastatic, or recurrent NSCLC patients who have received one prior platinum-based chemotherapy regimen
* ECOG performance status score of 0 or 1
Exclusion Criteria
* Symptomatic or uncontrolled brain metastases
* Evidence of meningeal metastasis
* \> 1 prior regimen (not counting adjuvant or neo-adjuvant cytotoxic chemotherapy if completed \> 12 months prior to regiment)
* Medical condition that would increase risk if treated with motexafin gadolinium or impair ability to complete study procedures and assessments
18 Years
ALL
No
Sponsors
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Pharmacyclics LLC.
INDUSTRY
Responsible Party
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Principal Investigators
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Martin Edelman, MD
Role: STUDY_CHAIR
University of Maryland, Greenbaum Cancer Center
Locations
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Huntington Beach, California, United States
Long Beach, California, United States
Chicago, Illinois, United States
Baltimore, Maryland, United States
Minneapolis, Minnesota, United States
St Louis, Missouri, United States
Albuquerque, New Mexico, United States
Santa Fe, New Mexico, United States
Armonk, New York, United States
Columbus, Ohio, United States
Seattle, Washington, United States
Countries
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References
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Biaglow JE, Miller RA. The thioredoxin reductase/thioredoxin system: novel redox targets for cancer therapy. Cancer Biol Ther. 2005 Jan;4(1):6-13. doi: 10.4161/cbt.4.1.1434. Epub 2004 Jan 8.
Evens AM. Motexafin gadolinium: a redox-active tumor selective agent for the treatment of cancer. Curr Opin Oncol. 2004 Nov;16(6):576-80. doi: 10.1097/01.cco.0000142073.29850.98.
Other Identifiers
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PCYC-0228
Identifier Type: -
Identifier Source: org_study_id