Clinical trial NCT00536874
Conditions: Pancreatic Cancer
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
Sponsor: Memorial Sloan Kettering Cancer Center
Start date: 2007-10-01; Completion date: 2017-02-01
Enrollment: 39 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief 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.

Detailed description:
OBJECTIVES:

Primary

* To determine the overall 18-month survival of patients with radiographically resectable pancreatic adenocarcinoma treated with neoadjuvant gemcitabine and oxaliplatin followed by surgical resection and adjuvant gemcitabine.

Secondary

* To determine the safety, toxicity, and feasibility of this regimen in the neoadjuvant setting.
* To determine the feasibility of obtaining preoperative core tissue biopsies and the ability to use these biopsies to establish pathologic correlates of response following neoadjuvant therapy and to determine if xenografts can be developed from these core tissues.
* To determine the specific tumor marker response (CEA and CA19-9) to neoadjuvant therapy.
* To determine the prognostic accuracy of serum protein profiles in these patients.
* To determine the overall survival and patterns of tumor recurrence (local vs distant).

OUTLINE:

* Neoadjuvant therapy: Patients receive gemcitabine IV over 100 minutes and oxaliplatin IV over 2 hours on day 1. Treatment repeats every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity.
* Surgery: Within 2-6 weeks after completion of neoadjuvant therapy, patients undergo a laparoscopy that includes a pancreaticoduodenectomy or distal pancreatectomy with or without splenectomy.
* Adjuvant therapy: Beginning 4-16 weeks after surgery, patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 5 courses in the absence of disease progression or unacceptable toxicity.

Patients undergo tumor tissue and blood sample collection periodically for correlative studies. Samples are analyzed for protein expression and tumor markers (CEA and CA19-9) pre- and post-neoadjuvant therapy via proteomic analysis. Tumor tissue samples are also banked for research purposes.

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

Arms: arm 1: A Phase II Study of Neoadjuvant Gemcitabine And Oxaliplatin In Patients With Potentially Resectable Previously Untreated Pancreatic Adenocarcinoma
Interventions: intervention 1: gemcitabine hydrochloride intervention 2: oxaliplatin intervention 3: protein expression analysis intervention 4: proteomic profiling intervention 5: diagnostic laboratory biomarker analysis intervention 6: adjuvant therapy intervention 7: neoadjuvant therapy intervention 8: therapeutic conventional surgery
Intervention descriptions: intervention 1: 1,000 mg/m2 IV over 100 minutes on day 1 every 14 days for 4 cycles intervention 2: 80 mg/m2 IV over 2 hours on day 1 every 14 days for 4 cycles. intervention 3: None intervention 4: None intervention 5: None intervention 6: None intervention 7: None intervention 8: None

Protocol documents: