Back to resultsTrial of Motexafin Gadolinium and Pemetrexed (Alimta®) for Second Line Treatment in Patients With Non-Small Cell Lung Cancer
Primary Purpose
Non-Small Cell Lung Carcinoma
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Motexafin gadolinium and pemetrexed
Sponsored by
About this trial
This is an interventional treatment trial for Non-Small Cell Lung Carcinoma focused on measuring Non Small Cell Lung Cancer, Lung Cancer, Metastatic Lung Cancer, Inoperable Lung Cancer, Advanced Lung Cancer, Large Cell Lung Cancer, Adenocarcinoma, lung, Squamous Cell Carcinoma, lung, Squamous Cell Lung Cancer, Large Cell Carcinoma, lung, Cancer of the Lung, Carcinoma, Bronchogenic
Eligibility Criteria
Inclusion Criteria: 18 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 Exclusion Criteria: 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Xcytrin® (motexafin gadolinium)
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Time to disease progression
Time to progression is defined as the time from first dose of MGd to first evidence of progression.
Overall survival
Patient population for this endpoint consists of all patients receiving at least 1 dose of MGd and pemetrexed.
Progression free survival
Progression-free survival is defined as the time from first dose MGd to the earlier of progression or death.
Response rate (CR+PR) by RECIST criteria
Patient population for this endpoint consists of all patients receiving at least 1 dose of MGd and pemetrexed and underwent at least response assessment.
Duaration of reponse (CR+PR)
Duration of response (CR + PR) is defined as the time from first response to the time of disease progression.
Clinical benefit rate (CR+PR+SD)
Patient population for this endpoint consists of all patients receiving at least 1 dose of MGd and pemetrexed and underwent at least response assessment
Safety and tolerability of MGd and pemetrexed
All patients who receive any MGd will be included in the safety summaries and analyses
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00365183
Brief Title
Trial of Motexafin Gadolinium and Pemetrexed (Alimta®) for Second Line Treatment in Patients With Non-Small Cell Lung Cancer
Official Title
Phase II Trial of Motexafin Gadolinium and Pemetrexed (Alimta®) for Second Line Treatment in Patients With Non-Small Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Terminated
Study Start Date
June 2006 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
June 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pharmacyclics LLC.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Carcinoma
Keywords
Non Small Cell Lung Cancer, Lung Cancer, Metastatic Lung Cancer, Inoperable Lung Cancer, Advanced Lung Cancer, Large Cell Lung Cancer, Adenocarcinoma, lung, Squamous Cell Carcinoma, lung, Squamous Cell Lung Cancer, Large Cell Carcinoma, lung, Cancer of the Lung, Carcinoma, Bronchogenic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
74 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Xcytrin® (motexafin gadolinium)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Motexafin gadolinium and pemetrexed
Other Intervention Name(s)
MGd and Alimta®
Intervention Description
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
Primary Outcome Measure Information:
Title
6 month progression free survival
Description
proportion of patients who are still alive and who have not progressed clinically or radiographically 6 months after receiving their first dose of MGd.
Time Frame
up to 2 years
Secondary Outcome Measure Information:
Title
Time to disease progression
Description
Time to progression is defined as the time from first dose of MGd to first evidence of progression.
Time Frame
up to 2 years
Title
Overall survival
Description
Patient population for this endpoint consists of all patients receiving at least 1 dose of MGd and pemetrexed.
Time Frame
up to 2 years
Title
Progression free survival
Description
Progression-free survival is defined as the time from first dose MGd to the earlier of progression or death.
Time Frame
up to 2 years
Title
Response rate (CR+PR) by RECIST criteria
Description
Patient population for this endpoint consists of all patients receiving at least 1 dose of MGd and pemetrexed and underwent at least response assessment.
Time Frame
up to 2 years
Title
Duaration of reponse (CR+PR)
Description
Duration of response (CR + PR) is defined as the time from first response to the time of disease progression.
Time Frame
up to 2 years
Title
Clinical benefit rate (CR+PR+SD)
Description
Patient population for this endpoint consists of all patients receiving at least 1 dose of MGd and pemetrexed and underwent at least response assessment
Time Frame
up to 2 years
Title
Safety and tolerability of MGd and pemetrexed
Description
All patients who receive any MGd will be included in the safety summaries and analyses
Time Frame
up to 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Edelman, MD
Organizational Affiliation
University of Maryland, Greenbaum Cancer Center
Official's Role
Study Chair
Facility Information:
City
Huntington Beach
State/Province
California
Country
United States
City
Long Beach
State/Province
California
Country
United States
City
Chicago
State/Province
Illinois
Country
United States
City
Baltimore
State/Province
Maryland
Country
United States
City
Minneapolis
State/Province
Minnesota
Country
United States
City
St. Louis
State/Province
Missouri
Country
United States
City
Albuquerque
State/Province
New Mexico
Country
United States
City
Santa Fe
State/Province
New Mexico
Country
United States
City
Armonk
State/Province
New York
Country
United States
City
Columbus
State/Province
Ohio
Country
United States
City
Seattle
State/Province
Washington
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
15684606
Citation
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.
Results Reference
background
PubMed Identifier
15627019
Citation
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.
Results Reference
background
Learn more about this trial
Trial of Motexafin Gadolinium and Pemetrexed (Alimta®) for Second Line Treatment in Patients With Non-Small Cell Lung Cancer
We'll reach out to this number within 24 hrs