Capecitabine and Oxaliplatin in Patients With Advanced or Metastatic Pancreatic Adenocarcinoma

Completed · Phase 2

Conditions studied: Pancreatic Cancer

In brief

There are limited treatment options available for patients with advanced pancreatic ductal adenocarcinoma (PDAC). The purpose of this study is to determine the effectiveness and safety of the drugs capecitabine and oxaliplatin in patients who have been diagnosed with advanced and metastatic PDAC treated in the first and second lines.

Key facts

Study ID

NCT00585078

Run by

Beth Israel Deaconess Medical Center

People needed

40

Starts

2004-05-01

Expected to finish

2011-12-01

Last updated by the study team

2017-04-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify 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

Where it is running

• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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