Study of Motexafin Gadolinium and Docetaxel for Advanced Solid Tumors

Inclusion criteria

• ≥ 18 years old
• Histologically or cytologically confirmed diagnosis of cancer (i.e., Unresectable locally advanced or metastatic non-small-cell lung carcinoma (NSCLC) that had progressed during or after one or more chemotherapy regimens; Metastatic breast cancer; Hormone-refractory prostate cancer; Recurrent or refractory ovarian cancer; Sarcoma)
• ECOG performance status score either 0 or 1
• Willing and able to provide written informed consent

Exclusion criteria

Laboratory Values of:

• Absolute neutrophil count < 2000/µL
• Platelet count < 100,00/µL
• AST or ALT > 1.5 x the upper limit of normal
• Alkaline phosphatase > 5 x the upper limit of normal
• Bilirubin > ULN
• Creatinine > 2.0 mg/dL

and

• Peripheral neuropathy NCI CTC Grade 3 or higher
• Chemotherapy, radiation therapy, immunotherapy, or systemic biologic
• anticancer therapy within 21 days before beginning study treatment
• Known history of brain metastases or spinal cord compression
• Uncontrolled hypertension
• Myocardial infarction within 6 months before beginning study treatment
• Unstable angina pectoris, uncontrolled congestive heart failure, or uncontrolled serious arrhythmias
• Known sensitivity to or intolerable adverse effects from taxanes or polysorbate 80
• Known history of porphyria (testing not required at screening)
• Known history of glucose-6-phosphate dehydrogenase (G6PD) deficiency (testing not required at screening)
• Known history of HIV infection (testing not required at screening)
• Female who is pregnant or lactating (pregnancy test is required for all female patients of childbearing potential)
• Female of childbearing potential or sexually active male unwilling to use adequate contraceptive protection
• Physical or mental condition that makes patient unable to complete specified follow-up assessments