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

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.

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