Gemcitabine and Oxaliplatin in Treating Patients With Pancreatic Cancer That Can Be Removed By Surgery
- Conditions
- Pancreatic Cancer
- Interventions
- Drug: gemcitabine hydrochlorideDrug: oxaliplatinGenetic: protein expression analysisGenetic: proteomic profilingOther: diagnostic laboratory biomarker analysisProcedure: adjuvant therapyProcedure: neoadjuvant therapyProcedure: therapeutic conventional surgery
- Registration Number
- NCT00536874
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 39
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Gemcitabine And Oxaliplatin proteomic profiling A Phase II Study of Neoadjuvant Gemcitabine And Oxaliplatin In Patients With Potentially Resectable Previously Untreated Pancreatic Adenocarcinoma Gemcitabine And Oxaliplatin diagnostic laboratory biomarker analysis A Phase II Study of Neoadjuvant Gemcitabine And Oxaliplatin In Patients With Potentially Resectable Previously Untreated Pancreatic Adenocarcinoma Gemcitabine And Oxaliplatin adjuvant therapy A Phase II Study of Neoadjuvant Gemcitabine And Oxaliplatin In Patients With Potentially Resectable Previously Untreated Pancreatic Adenocarcinoma Gemcitabine And Oxaliplatin neoadjuvant therapy A Phase II Study of Neoadjuvant Gemcitabine And Oxaliplatin In Patients With Potentially Resectable Previously Untreated Pancreatic Adenocarcinoma Gemcitabine And Oxaliplatin therapeutic conventional surgery A Phase II Study of Neoadjuvant Gemcitabine And Oxaliplatin In Patients With Potentially Resectable Previously Untreated Pancreatic Adenocarcinoma Gemcitabine And Oxaliplatin gemcitabine hydrochloride A Phase II Study of Neoadjuvant Gemcitabine And Oxaliplatin In Patients With Potentially Resectable Previously Untreated Pancreatic Adenocarcinoma Gemcitabine And Oxaliplatin protein expression analysis A Phase II Study of Neoadjuvant Gemcitabine And Oxaliplatin In Patients With Potentially Resectable Previously Untreated Pancreatic Adenocarcinoma Gemcitabine And Oxaliplatin oxaliplatin A Phase II Study of Neoadjuvant Gemcitabine And Oxaliplatin In Patients With Potentially Resectable Previously Untreated Pancreatic Adenocarcinoma
- Primary Outcome Measures
Name Time Method Overall Survival at 18 Months 18 months Percentage of participants that were alive or survived at 18 months after randomization
- Secondary Outcome Measures
Name Time Method Specific Tumor Marker Response (CEA) to Neoadjuvant Therapy Baseline and 2 years Percentage change in specific tumor marker (Carcinoembryonic antigen, CEA) levels in response to neoadjuvant therapy
RECIST Radiologic Response to Neoadjuvant Therapy 2 years Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR)=CR +PR
Specific Tumor Marker Response (Ca 19-9) to Neoadjuvant Therapy Baseline and 2 years Percent change in specific tumor marker (Cancer Antigen 19-9, Ca 19-9) levels in response to neoadjuvant therapy
Overall Survival (Follow-Up Time) From Baseline until 2 Years and Follow-Up, up to 120 months
Trial Locations
- Locations (1)
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States