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