Trial of Motexafin Gadolinium and Pemetrexed (Alimta®) for Second Line Treatment in Patients With Non-Small Cell Lung Cancer
Phase II Trial of Motexafin Gadolinium and Pemetrexed (Alimta®) for Second Line Treatment in Patients With Non-Small Cell Lung Cancer
1 other identifier
interventional
74
1 country
11
Brief Summary
The goals of this study are:
- 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jun 2006
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2006
CompletedFirst Submitted
Initial submission to the registry
August 15, 2006
CompletedFirst Posted
Study publicly available on registry
August 17, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2008
CompletedOctober 31, 2013
October 1, 2013
1.6 years
August 15, 2006
October 29, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
6 month progression free survival
proportion of patients who are still alive and who have not progressed clinically or radiographically 6 months after receiving their first dose of MGd.
up to 2 years
Secondary Outcomes (7)
Time to disease progression
up to 2 years
Overall survival
up to 2 years
Progression free survival
up to 2 years
Response rate (CR+PR) by RECIST criteria
up to 2 years
Duaration of reponse (CR+PR)
up to 2 years
- +2 more secondary outcomes
Study Arms (1)
Xcytrin® (motexafin gadolinium)
EXPERIMENTALInterventions
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
Eligibility Criteria
You may qualify if:
- years or older
- Stage IIIb, metastatic, or recurrent NSCLC patients who have received one prior platinum-based chemotherapy regimen
- ECOG performance status score of 0 or 1
You may not qualify if:
- Laboratory values indicating inadequate function of bone marrow, liver, or kidneys
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Unknown Facility
Huntington Beach, California, United States
Unknown Facility
Long Beach, California, United States
Unknown Facility
Chicago, Illinois, United States
Unknown Facility
Baltimore, Maryland, United States
Unknown Facility
Minneapolis, Minnesota, United States
Unknown Facility
St Louis, Missouri, United States
Unknown Facility
Albuquerque, New Mexico, United States
Unknown Facility
Santa Fe, New Mexico, United States
Unknown Facility
Armonk, New York, United States
Unknown Facility
Columbus, Ohio, United States
Unknown Facility
Seattle, Washington, United States
Related Publications (2)
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.
PMID: 15684606BACKGROUNDEvens 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.
PMID: 15627019BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Martin Edelman, MD
University of Maryland, Greenbaum Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 15, 2006
First Posted
August 17, 2006
Study Start
June 1, 2006
Primary Completion
January 1, 2008
Study Completion
June 1, 2008
Last Updated
October 31, 2013
Record last verified: 2013-10