• Overall response rate [ Designated as safety issue: No ]
• Duration of response [ Designated as safety issue: No ]
• Time to disease progression [ Designated as safety issue: No ]
• Overall survival [ Designated as safety issue: No ]
• Toxicity and safety [ Designated as safety issue: Yes ]

• Overall response rate
• Duration of response
• Time to disease progression
• Overall survival
• Toxicity and safety

RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bortezomib together with carboplatin may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving bortezomib together with carboplatin works in treating patients with metastatic pancreatic cancer.

OBJECTIVES:

Primary

• Assess overall survival at 6 months in patients with previously treated metastatic pancreatic cancer treated with bortezomib and carboplatin.

Secondary

• Determine the objective tumor response rate, duration of response, time to tumor progression, and overall survival of patients treated with this regimen.
• Assess the safety profile of this regimen in these patients.

OUTLINE: Patients receive bortezomib IV on days 1, 4, 8, and 11 and carboplatin IV over 30 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 39 patients will be accrued for this study.

• Drug: bortezomib
• Drug: carboplatin

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed adenocarcinoma or carcinoma of the pancreas that is metastatic and not amenable to resection with curative intent

  • No locally advanced disease

• Measurable disease

  • Primary mass in the pancreas is not considered measurable disease
  • Measurable disease must be outside a previous radiation field OR a new lesion must be present inside the port

• Must have received 1 (and only 1) prior systemic regimen for metastatic disease

  • Chemotherapy administered as adjuvant therapy or radiation sensitization is not considered a regimen if it was received ≥ 6 months ago
  • A systemic regimen administered for unresectable locally advanced disease that subsequently progressed to metastatic will be counted as 1 prior regimen

• No known brain metastases

  • Brain imaging studies are not required if patient has no neurological signs or symptoms of brain metastases

PATIENT CHARACTERISTICS:

• ECOG performance status (PS) 0-1 OR Karnofsky PS 70-100%
• Absolute neutrophil count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• Hemoglobin ≥ 9 g/dL
• Bilirubin ≤ 1.5 times upper limit of normal (ULN)
• AST and ALT ≤ 2.5 times ULN (5 times ULN if liver metastasis is present)
• Creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 60 mL/min

• No significant history of cardiac disease, including any of the following:

  • Unstable angina
  • New York Heart Association class III or IV congestive heart failure
  • Myocardial infarction within the past 6 months
• No neurotoxicity > grade 1

• No other prior malignancy requiring active treatment

  • No radiographic evidence of a second malignancy
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• Prior cisplatin or oxaliplatin allowed
• At least 3 weeks since prior radiation therapy and recovered
• At least 2 weeks since prior major surgery and recovered
• At least 4 weeks since prior chemotherapy (2 weeks for chemotherapy administered on a daily or weekly schedule) and recovered
• No prior carboplatin, bortezomib, or another proteasome inhibitor

• No other concurrent anticancer treatment, including any of the following:

  • Chemotherapy
  • Radiation therapy
  • Biologic agents
  • Other investigational drugs
• No concurrent combination antiretroviral therapy for HIV-positive patients
• Adjuvant hormonal therapy for breast cancer or prostate cancer allowed