Gemcitabine and Oxaliplatin in Treating Patients With Pancreatic Cancer That Can Be Removed By Surgery
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Intervention: gemcitabine hydrochloride; oxaliplatin; protein expression analysis; proteomic profiling; diagnostic laboratory biomarker analysis; adjuvant therapy; neoadjuvant therapy; therapeutic conventional surgery
Intervention description: 1,000 mg/m2 IV over 100 minutes on day 1 every 14 days for 4 cycles; 80 mg/m2 IV over 2 hours on day 1 every 14 days for 4 cycles.
Intervention MeSH terms: Gemcitabine; Oxaliplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 39.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: adenocarcinoma of the pancreas; stage IA pancreatic cancer; stage IB pancreatic cancer; stage IIA pancreatic cancer; stage IIB pancreatic cancer; stage III pancreatic cancer

Summary:

      RATIONALE: Drugs used in chemotherapy, such as gemcitabine and oxaliplatin, work in different
      ways to stop the growth of tumor cells, either by killing the cells or by stopping them from
      dividing. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount
      of normal tissue that needs to be removed. Giving chemotherapy after surgery may kill any
      tumor cells that remain after surgery.

      PURPOSE: This phase II trial is studying how well giving gemcitabine together with
      oxaliplatin works in treating patients with pancreatic cancer that can be removed by surgery.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically or cytologically confirmed pancreatic adenocarcinoma

               -  No histology other than adenocarcinoma (e.g., neuroendocrine cancer or acinar
                  cancer)

                    -  Patients with adenosquamous variants are eligible

          -  Radiographically resectable pancreatic cancer, as determined by a surgical oncologist

               -  No metastatic or locally unresectable pancreatic adenocarcinoma

          -  No evidence of distant metastases by CT scan

               -  Negative or pending laparoscopy for distant metastases

        PATIENT CHARACTERISTICS:

          -  ECOG performance status 0-2

          -  Absolute neutrophil count ≥ 1,500/mm³

          -  Platelet count ≥ 100,000/mm³

          -  Bilirubin ≤ 4.0 mg/dL (if > 3.0, stented and known to be declining)

          -  Serum creatinine ≤ 1.6 mg/dL

          -  INR < 1.5 (therapeutic INR is allowed for patients receiving therapeutic
             anticoagulation)

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception during and for 3 months after
             completion of study therapy

          -  No active infection, except for resolving cholangitis, that would preclude study
             enrollment

               -  Neoadjuvant therapy may only be initiated when acute cholangitis has resolved

          -  No other malignancy within the past 3 years except for curatively treated basal cell
             carcinoma of the skin, cervical intraepithelial neoplasia, or localized prostate
             cancer with a PSA of < 5.0 ng/mL within ≥ 4 weeks of study entry (other circumstances
             with a recent concurrent or active malignancy will be adjudicated on a case-by-case
             basis by the principle investigator [PI] or co-PI)

          -  No known hypersensitivity to any of the components of oxaliplatin or gemcitabine

          -  No hypersensitivity to CT scan IV contrast dye not suitable for premedication

          -  No peripheral neuropathy ≥ grade 2

          -  No known HIV or hepatitis B or C infection (active, previously treated, or both)

          -  No other medical condition, including mental illness or substance abuse that, deemed
             by the investigator, would preclude study participation

        PRIOR CONCURRENT THERAPY:

          -  More than 4 weeks since prior radiotherapy

          -  No prior radiotherapy to > 25% of bone marrow

          -  More than 30 days since prior and no other concurrent investigational therapy

          -  No other prior therapy for pancreatic cancer

          -  No other concurrent chemotherapy, immunotherapy, or radiotherapy during neoadjuvant
             therapy

          -  Concurrent low molecular weight heparin or warfarin, where medically indicated,
             allowed