Clinical trialPhase 2Completed
Capecitabine and Oxaliplatin in Patients With Advanced or Metastatic Pancreatic Adenocarcinoma
- Outcome
- Outcome unknown
- Phase
- Phase 2
- Status
- Completed
- Study type
- Interventional
- Start
- May 2004
- Expected end
- December 2011
- Enrollment
- 40 participants
- Sites
- 1
- Primary outcomes
- Response Rate
- Sponsor
- Other
- Results posted
- 2017-04-10
- Last update
- 10 April 2017
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Brief summary public domain (ClinicalTrials.gov)
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 public domain (ClinicalTrials.gov)
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
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Response Rate [Response was assessed by computed tomography (CT) or magnetic resonance imaging (MRI) every two cycles (42 days ±2 days) on treatment. Participants received a median (range) of 2 cycles (1-12) of CAPOX.]. Number, proportion of participants (80% Confidence Interval). CAPOX (n=24): .125 (.035 to .201).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Best Response [Response was assessed by computed tomography (CT) or magnetic resonance imaging (MRI) every two cycles (42 days ±2 days) on treatment. Participants received a median (range) of 2 cycles (1-12) of CAPOX.]. Number, participants. Complete Response: CAPOX (n=24): 0. Partial Response: CAPOX (n=24): 3. Stable Disease: CAPOX (n=24): 13. Progressive Disease: CAPOX (n=24): 8.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Overall Survival [Participants were followed long-term for survival every 3 months from the end of treatment until death or lost to follow-up. Median survival follow-up was 10.8 months (95% CI: 7.1-37.7) in this study cohort.]. Median, months (95% Confidence Interval). CAPOX (n=37): 7.4 (4.8 to 12.2).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Progression-Free Survival [Disease evaluations occurred every two cycles (42 days ±2 days) on treatment. In this study cohort, participants were followed for progression up to 38 months.]. Median, months (95% Confidence Interval). CAPOX (n=24): 3.8 (1.3 to 6.2).