Clinical trial NCT00585078: Capecitabine and Oxaliplatin in Patients With Advanced or Metastatic Pancreatic Adenocarcinoma
Official title: Capecitabine and Oxaliplatin in Patients With Advanced or Metastatic Pancreatic Adenocarcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pancreatic Cancer
Keywords: capecitabine
oxaliplatin
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: Sanofi
First posted: 2008-01-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility 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

Primary outcomes:
measure: Response Rate
timeFrame: 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.
Secondary outcomes:
measure: Best Response
timeFrame: 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.
measure: Overall Survival
timeFrame: 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.
measure: Progression-Free Survival
timeFrame: 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.
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Rebecca Miksad, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: