Study of Gemcitabine and Oxaliplatin With Radiation Therapy in Patients With Pancreatic Cancer

Study Overview
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Brief Summary
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This study will examine a sequence of treatments including pre-operative chemotherapy and radiation, surgery and post-operative chemotherapy for resectable pancreatic cancer.

Detailed Description
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This study will examine a sequence of treatments including pre-operative chemotherapy and radiation, surgery and post-operative chemotherapy for resectable pancreatic cancer. This research treatment will evaluate the combination of two chemotherapy agents, oxaliplatin and gemcitabine with radiation therapy. The researchers have already done studies using oxaliplatin, gemcitabine and radiation therapy together for pancreatic cancer. They want to build on the information they have from this previous research and do the research at multiple sites. They will use this study to determine how well people do who are treated with gemcitabine, oxaliplatin, and radiation therapy prior to having surgery for their pancreatic cancer. The researchers will also gather more information about what type of side effects occur with this treatment.

Official Title
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A Multi-Institutional Phase II Study of Neoadjuvant Gemcitabine and Oxaliplatin With Radiation Therapy in Patients With Pancreatic Cancer

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Drug: gemcitabine
* Drug: oxaliplatin
* Procedure: Radiation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must have cytologic or histologic confirmation of carcinoma arising in the pancreas. Patients must be deemed resectable or borderline resectable based on criteria in section 4.2 prior to registration. Patients must have an expected life expectancy of at least 12 weeks and a Zubrod performance status of < 2. Patients must have adequate organ function defined as follows: absolute neutrophil count of > 1500/mm3, platelets > 100,000/mm3, serum Cr < 1.5 mg/dl, total bilirubin < 3.0 mg/dl with relief of biliary obstruction if present (PTC tube or endobiliary stent). Patients must be free of other active systemic malignancy, ongoing infection, including HIV infection, or any other serious uncontrolled, concomitant systemic disorders or psychiatric condition that would interfere with the safe delivery of protocol therapy. Patients must be aware of the investigational nature of the therapy and provide written informed consent. Patients must have no history of previous chemotherapy for pancreatic cancer or any abdominal radiation therapy. Patients must not have used any investigational agent in the month before enrollment into the study. Exclusion Criteria: Patients with neuroendocrine tumors are excluded. Patients with preexisting peripheral neuropathy > grade 2 are ineligible. Pregnant or nursing women are ineligible and patients of reproductive potential must agree to use an effective contraceptive method during participation in this trial and for 6 months after trial.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oxaliplatin & gemcitabine with radiation<br>This study will examine a sequence of treatments including pre-operative chemotherapy and radiation, surgery and post-operative chemotherapy for resectable pancreatic cancer. | Drug: gemcitabine<br>* Gemcitabine 1000mg/m2 will be infused over 30 minutes on days 1, 8, and 15 of a treatment cycle.<br>* Other names: Gemzar;Drug: oxaliplatin<br>* Oxaliplatin 85mg/m2 will be infused following gemcitabine over approximately 90 minutes on days 1 and 15 of a treatment cycle.<br>* Other names: Eloxatin;Procedure: Radiation<br>* The total dose in a three week treatment block will be 30 Gy in 2.0 Gy fractions.<br>* Other names: RT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Two-year Disease Free Survival. | The percent of patients alive and disease-free at two years. | two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Treatment Failure | Median time for disease recurrence after surgery. | 2 years | 
| Overall Survival | Percent overall survival was calculated for all evaluable patients. | 5 years |