Capecitabine and Oxaliplatin in Patients With Advanced or Metastatic Pancreatic Adenocarcinoma
This trial is active, not recruiting.
|Sponsor||Beth Israel Deaconess Medical Center|
|Start date||April 2004|
|End date||July 2016|
|Trial size||37 participants|
|Trial identifier||NCT00585078, 03-398, OX-03-033|
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.
|Intervention model||single group assignment|
Capecitabine and Oxaliplatin
To determine the response rate to capecitabine and oxaliplatin in patients with locally advanced or metastatic pancreatic adenocarcinoma
time frame: 4 years
To determine the safety of capecitabine and oxaliplatin in patients with locally advanced or metastatic pancreatic adenocarcinoma
time frame: 4 years
To determine the overall survival of patients treated with capecitabine and oxaliplatin in this patient population
time frame: TBD
To determine the time to progression for patients treated with capecitabine and oxaliplatin in this patient population
time frame: TBD
All participants at least 18 years old.
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
|Official title||Capecitabine and Oxaliplatin in Patients With Advanced or Metastatic Pancreatic Adenocarcinoma|
|Principal investigator||Rebecca Miksad, MD, MPH|
|Description||- 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.|
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