Gemcitabine and Oxaliplatin in Treating Patients With Pancreatic Cancer That Can Be Removed By Su… (NCT00536874) | Clinical Trial Compass
CompletedPhase 2
Gemcitabine and Oxaliplatin in Treating Patients With Pancreatic Cancer That Can Be Removed By Surgery
United States39 participantsStarted 2007-10
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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…