| Inclusion Criteria: | 1) Patients must have histologically or cytologically confirmed adenocarcinoma or carcinoma of the pancreas that is metastatic and not amenable to resection with curative intent.
2) Patients must have measurable disease defined by RECIST criteria. For the purpose of this study, primary mass in the pancreas is not considered as measurable disease.
3) Patients must have received one (1), and only one, prior systemic regimen for metastatic disease. Patients who have received prior cisplatin or oxaliplatin are eligible. A systemic regimen administered for unresectable locally advanced disease that subsequently progressed to metastatic will be counted as 1 prior regimen. Chemotherapy administered as adjuvant therapy or as a radiation sensitizer is not counted as a prior regimen.
4) Prior radiation is permitted; however, at least 3 weeks must have elapsed since the completion of prior radiation therapy and patients must have recovered from all associated toxicities to NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 </= Grade 1 at the time of registration. Measurable disease must be outside the previous radiation field or a new lesion inside the port must be present.
5) At least two weeks must have elapsed since any major surgery and patients must have recovered from all associated toxicities to </= CTCAE Grade 1 at the time of registration
6) At least 4 weeks must have elapsed since previous chemotherapy except for regimens that are administered on a daily, weekly, or every other week schedule, in which case at least 2 weeks must have elapsed since previous chemotherapy. Patients must have recovered from all associated toxicities to CTCAE </= Grade 1 at the time of registration
7) Age >/= 18 years. Because no dosing or adverse event data are currently available on the use of bortezomib in combination with carboplatin in patients <18 years of age, children are excluded from this study but will be eligible for future pediatric phase 2 combination trials.
8) ECOG performance status </=1 (Karnofsky >/= 70%).
9) Patients must have adequate organ and marrow function as defined below: absolute neutrophil count >/= 1,500/mcL; platelets >/= 100,000/mcL; hemoglobin >/= 9 g/dl; total bilirubin </= 1.5 X institutional upper limit of normal; AST(SGOT) & ALT(SGPT) </= 2.5 X institutional upper limit of normal or </= 5 X institutional upper limit of normal if patient has liver metastasis; creatinine </= 1.5 mg/dL OR creatinine clearance >/= 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal.
10) Other prior malignancy is allowed as long as the patient does not require active treatment for their second malignancy and there is no radiographic evidence of second malignancy. Patients who are receiving hormonal therapy for breast or prostate cancer as adjuvant treatment are eligible.
11) The effects of bortezomib on the developing human fetus at the recommended therapeutic dose are unknown. For this reason and because carboplatin, the other therapeutic agent used in this trial, is known to be teratogenic, women of child-bearing potential and men of reproductive potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
12) Ability to understand and the willingness to sign a written informed consent document. Written informed consent must be obtained prior to any evaluations being performed solely for the purposes of screening for eligibility for this study. |