Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Beth Israel Deaconess Medical Center
With
Sanofi
OBJECTIVES:
Primary
* To determine the response rate to capecitabine and oxaliplatin in patients with locally advanced or metastatic pancreatic adenocarcinoma Secondary
* To determine safety
* To determine overall survival
* To determine time to progression
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
18 years of age or older
At most one prior chemotherapy regimen for unresectable or metastatic disease. Any adjuvant chemotherapy must have been completed more than 12 months prior to beginning protocol therapy
Histologically or cytologically confirmed adenocarcinoma of the pancreas
At least one measurable lesion according to RECIST criteria that has not been irradiated
Adequate laboratory parameters as outlined in protocol
Anticoagulation with coumadin is permitted, but PT/INR must be monitored closely, given the drug-drug interaction between coumadin and capecitabine
Negative serum pregnancy test within 14 days prior to registration
You may not be if
Pregnant or lactating women
Life expectancy \< 3 months
Serious, uncontrolled, concurrent infection(s)
Any prior oxaliplatin or fluoropyrimidine therapy
More than one prior chemotherapy regimen for unresectable or metastatic disease
Prior unanticipated severe reaction to fluoropyrimidine therapy, or known sensitivity to 5-fluorouracil or platinum compounds
Any active second malignancy
Clinically significant cardiac disease or myocardial infarction within the last 12 months
Evidence of CNS metastases or history of uncontrolled seizures, central nervous system disorders or psychiatric disability
Other serious uncontrolled medical conditions
Major surgery within 4 weeks of the start of study treatment, without complete recovery
Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome
Known, existing uncontrolled coagulopathy
Clareo Health | Capecitabine and Oxaliplatin in Patients With Advanced or Metastatic Pancreatic Adenocarcinoma
