Phase I Trial of Motexafin Gadolinium (MGd) and Docetaxel Administered at 3-Week Intervals 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