Expired Study
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Boston, Massachusetts 02115


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 pancreatic cancer.

Study summary:

- Participants will receive capecitabine orally twice daily for 14 days, from the evening of Day 1 to the morning of Day 15 of the study, and oxaliplatin on Day 1 of each cycle (one cycle is 3 weeks long) until their cancer worsens or they experience any serious side effects. - Participants will undergo the following procedures midcycle (between Days 10 and 14 of each cycle): Symptom and side effect assessment and blood samples. - After every two cycles of study treatment, participants will undergo a CT or MRI scan to measure the tumor.


Inclusion Criteria: - 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 Exclusion Criteria: - 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



Primary Contact:

Principal Investigator
Rebecca Miksad, MD, MPH
Beth Israel Deaconess Medical Center

Backup Contact:


Location Contact:

Boston, Massachusetts 02115
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: February 04, 2019

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