Trial of Motexafin Gadolinium and Pemetrexed (Alimta®) for Second Line Treatment in Patients With Non-Small Cell Lung Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Phase II Trial of Motexafin Gadolinium and Pemetrexed (Alimta®) for Second Line Treatment in Patients With Non-Small Cell Lung Cancer

Conditions
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Non-Small Cell Lung Carcinoma

Intervention / Treatment
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* Drug: Motexafin gadolinium and pemetrexed


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Xcytrin® (motexafin gadolinium)<br> | Drug: Motexafin gadolinium and pemetrexed<br>* 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<br>* Other names: MGd and Alimta®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to disease progression | Time to progression is defined as the time from first dose of MGd to first evidence of progression. | up to 2 years | 
| Overall survival | Patient population for this endpoint consists of all patients receiving at least 1 dose of MGd and pemetrexed. | up to 2 years | 
| Progression free survival | Progression-free survival is defined as the time from first dose MGd to the earlier of progression or death. | up to 2 years | 
| 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. | up to 2 years | 
| Duaration of reponse (CR+PR) | Duration of response (CR + PR) is defined as the time from first response to the time of disease progression. | up to 2 years | 
| 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 | up to 2 years | 
| Safety and tolerability of MGd and pemetrexed | All patients who receive any MGd will be included in the safety summaries and analyses | up to 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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