Phase I Dose Escalation Study of VELCADE Plus Docetaxel in Patients With Advanced Non-Small Cell Lung Cancer or Other Solid Tumors

Patient previously received treatment with docetaxel.

Patient previously received treatment with cisplatin at a cumulative dose \>350 mg/m2.

Patient has received chemotherapy within four weeks, nitrosoureas within six weeks, or antibody therapy within eight weeks of enrollment.

Patient has received radiation therapy within four weeks of enrollment.

Patient has a history of radiation therapy to \>25% of bone marrow.

Patient has not recovered from all toxic effects of previous chemotherapy or radiation or antibody therapy.

Patient has had any major surgery within four weeks of enrollment.

Patient has a history of allergic reactions to appropriate diuretics or anti-emetics to be administered in conjunction with study drug.

Patient has a history of severe hypersensitivity reaction to docetaxel or other agents formulated with polysorbate 80.

Patient has electrocardiographic evidence of acute ischemia or new conduction system abnormalities.

Patient has had a myocardial infarction within six months of enrollment.

Patient has uncontrolled brain metastases or central nervous system disease.

Patients with controlled brain metastases who are not receiving corticosteroids or anticonvulsants are eligible for study enrollment.

Patient has Grade 2 or higher peripheral neuropathy

Patient has leukemia or lymphoma.

Patient has any of the following pretreatment laboratory data within 21 days before the first study drug dose:

Total bilirubin \> than the upper limit of normal (ULN).

Alanine transaminase (ALT) and/or aspartate transaminase (AST) \>1.5 x the ULN concurrent with alkaline phosphatase \>2.5 x the ULN.

Patient is HIV-infected.

Patient is hepatitis B surface antigen positive or has previously documented hepatitis C

Patient has an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.

Patient has another serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol.

Female patient is pregnant or breast-feeding.

What this study is about