Bortezomib and Gemcitabine in Treating Older Patients With Advanced Solid Tumors

Inclusion Criteria

• •Histologically or cytologically confirmed diagnosis of advanced non-hematologic malignancy, including any of the following:
• •* Breast cancer
• •* Lung cancer
• •* Colon cancer
• •* Pancreatic cancer
• •* Head and neck cancer
• •* Sarcoma
• •Must have failed or become intolerant to prior standard therapy and is no longer likely to respond to such therapy (for all diseases except pancreatic cancer)
• •* Pancreatic cancer patients may be enrolled with no prior therapy requirements since gemcitabine is the current standard of care 1st line therapy
• •Measurable or nonmeasurable disease
• •Concurrent enrollment in the University of Minnesota study "Population Pharmacokinetics and Pharmacogenetics of Gemcitabine in Adult Patients with Solid Tumors" (Human Subjects Code 0508M72989) required
• •ECOG performance status of 0-1
• •Absolute neutrophil count ≥ 1,500/mm³
• •Platelet count ≥ 100,000/mm³
• •Hemoglobin ≥ 10 g/dL
• •Bilirubin ≤ 1.5 times upper limit of normal (ULN)
• •Alkaline phosphatase ≤ 3.0 times ULN (5 times ULN if liver has tumor involvement)
• •Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 times ULN (5 times ULN if liver has tumor involvement)
• •Calculated or measured creatinine clearance \> 30 mL/minute
• •Fertile patients must use effective contraception during and for 3 months after study participation
• •Recovered from all prior therapy
• •Prior systemic chemotherapy, immunotherapy, or biological therapy allowed
• •At least 3 months since prior bortezomib and/or gemcitabine
• •At least 2 weeks since prior systemic therapy
• •At least 3 weeks since prior investigational agents (for reasons other than the treatment of cancer)
• •At least 2 weeks since prior radiotherapy