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

Exclusion Criteria:

Symptomatic brain metastases
Serious concomitant medical or psychiatric disorders (e.g., active infection or uncontrolled diabetes) that, in the opinion of the investigator, would compromise the safety of the patient or compromise the patient's ability to complete the study
Myocardial infarction within the past 6 months
New York Heart Association (NYHA) Class III or IV heart failure
Uncontrolled angina
Severe uncontrolled ventricular arrhythmias
Electrocardiographic evidence of acute ischemia or active conduction system abnormalities
Peripheral neuropathy ≥ grade 2
Known hypersensitivity to bortezomib, boron or mannitol
Prior radiotherapy to ≥ 25% of the bone marrow
Prior radiotherapy to the whole pelvis
Concurrent filgrastim (G-CSF) or other hematologic support during course 1 of study treatment