Conditions: Pancreatic Cancer
Keywords: capecitabine oxaliplatin
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 40
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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

Arms:
arm 1: Participants self-administered capecitabine 1,000 mg/m2 orally twice daily (total daily dose 2,000 mg/m2), days 1-14 in 21-day cycles. Only 500 mg tablets were used, and doses were rounded to the nearest dose that could be administered with 500 mg tablets. Oxaliplatin 130 mg/m2 was administered intravenously on day 1 every 21 (±2) days. Treatment continued until tumor progression or toxicity requiring discontinuation of therapy.

Interventions: intervention 1: Capecitabine intervention 2: Oxaliplatin
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: