- Male or post menopausal female patients with histologically confirmed advanced
refractory solid tumors for which no reasonable therapy exists. Patient is not
required to have measurable disease.
- Age >18 years
- Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of
0, 1, or 2 (see APPENDIX 1 for details).
- Patients who had prior surgery, radiation, or chemotherapy will be eligible provided
at least 4 weeks have elapsed prior to study initiation. Patients must have
recovered from treatment-related toxicities, and surgical wounds must be healed.
- Patients who have had prior immunotherapy with approved agents are eligible.
- Patients must have hemoglobin >10.0 g/dL, ANC >1,000/mm3, WBC >3,000/mm3,000/mm3,
platelets ³100,000/mm3, bilirubin £2.0 mg/dL, AST/ALT no greater than 5 times the
upper limit of normal (ULN), and serum creatinine <1.5 mg/dL (or calculated
creatinine clearance ³60 mL/min).
- Patients must have prothrombin time (PT) and partial thromboplatin time (PTT) less
than upper limit of normal or international normalized ratio (INR) less than 1.1.
- Patients must have thyroxine (T4) and thyroid-stimulating hormone (TSH) within normal
- Patients must be informed of and understand the investigational nature of this trial
and give written informed consent prior to receipt of any study medication or
beginning study procedures.
- Patient has known brain metastases or primary brain tumors, symptomatic pleural
effusion or ascites requiring paracentesis.
- Patient has respiratory insufficiency requiring oxygen treatment, or has lymphangitic
involvement of lungs.
- Patient has evidence of hematemesis, melena, hematochezia, or hematuria (2 or greater
on urine dipstick).
- Patient has a history of a significant adverse event related to previously
administered humanized monoclonal antibody.
- Patient has known HIV or hepatitis virus infection.
- Patient has prior myocardial infarction or angina, or uncontrolled hypertension
(systolic BP >140 mm Hg).
- Patient has either prior strokes or transient ischemic attacks.
- Patient has active infections requiring systemic antiinfective therapy or other
physical or psychological illnesses that would preclude drug administration or
- Patient has donated blood or received an investigational agent in the last 4 weeks.
- Patient has a history of active illness or behavior, including substance dependence
or abuse that, in the opinion of the investigator, might pose additional risk in
administering the study drug to the patient.
- General medical or psychological conditions that would not permit the patient to
complete the study or sign the informed consent