Expired Study
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Boston, Massachusetts 02115


Purpose:

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.


Criteria:

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


NCT ID:

NCT00585078


Primary Contact:

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


Backup Contact:

N/A


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: January 23, 2018

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