Gemcitabine and Oxaliplatin in Treating Patients With Pancreatic Cancer That Can Be Removed By Surgery
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|ClinicalTrials.gov Identifier: NCT00536874|
Recruitment Status : Completed
First Posted : September 28, 2007
Results First Posted : December 17, 2015
Last Update Posted : March 16, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Drug: gemcitabine hydrochloride Drug: oxaliplatin Genetic: protein expression analysis Genetic: proteomic profiling Other: diagnostic laboratory biomarker analysis Procedure: adjuvant therapy Procedure: neoadjuvant therapy Procedure: therapeutic conventional surgery||Phase 2|
- 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.
- 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).
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||39 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Neoadjuvant Gemcitabine and Oxaliplatin in Patients With Potentially Resectable Previously Untreated Pancreatic Adenocarcinoma|
|Study Start Date :||October 2007|
|Primary Completion Date :||September 2012|
|Study Completion Date :||February 2017|
Experimental: Gemcitabine And Oxaliplatin
A Phase II Study of Neoadjuvant Gemcitabine And Oxaliplatin In Patients With Potentially Resectable Previously Untreated Pancreatic Adenocarcinoma
Drug: gemcitabine hydrochloride
1,000 mg/m2 IV over 100 minutes on day 1 every 14 days for 4 cyclesDrug: oxaliplatin
80 mg/m2 IV over 2 hours on day 1 every 14 days for 4 cycles.Genetic: protein expression analysis Genetic: proteomic profiling Other: diagnostic laboratory biomarker analysis Procedure: adjuvant therapy Procedure: neoadjuvant therapy Procedure: therapeutic conventional surgery
- Overall Survival at 18 Months [ Time Frame: 18 months ]Percentage of participants that were alive or survived at 18 months after randomization
- Overall Survival (Follow-Up Time) [ Time Frame: From Baseline until 2 Years and Follow-Up, up to 120 months ]
- Specific Tumor Marker Response (CEA) to Neoadjuvant Therapy [ Time Frame: Baseline and 2 years ]
- RECIST Radiologic Response to Neoadjuvant Therapy [ Time Frame: 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 [ Time Frame: Baseline and 2 years ]
- Specific Tumor Marker Response (CEA) to Neoadjuvant Therapy [ Time Frame: Baseline and 2 years ]Percentage change in specific tumor marker (Carcinoembryonic antigen, CEA) levels in response to neoadjuvant therapy
- Specific Tumor Marker Response (Ca 19-9) to Neoadjuvant Therapy [ Time Frame: Baseline and 2 years ]Percent change in specific tumor marker (Cancer Antigen 19-9, Ca 19-9) levels in response to neoadjuvant therapy
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00536874
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10065-0009|
|Principal Investigator:||Eileen O'Reilly, MD||Memorial Sloan Kettering Cancer Center|
|Principal Investigator:||Peter J. Allen, MD||Memorial Sloan Kettering Cancer Center|