Overview

This trial is active, not recruiting.

Condition pancreatic cancer
Treatments capecitabine, oxaliplatin
Phase phase 2
Sponsor Beth Israel Deaconess Medical Center
Collaborator Sanofi
Start date April 2004
End date July 2014
Trial size 37 participants
Trial identifier NCT00585078, 03-398, OX-03-033

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Capecitabine and Oxaliplatin
capecitabine Xeloda
Orally twice a day for 14 days, from the evening of Day 1 to the morning of Day 15 of each 3-week cycle.
oxaliplatin
Given on Day 1 of each 3-week cycle

Primary Outcomes

Measure
To determine the response rate to capecitabine and oxaliplatin in patients with locally advanced or metastatic pancreatic adenocarcinoma
time frame: 4 years

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female 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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Dana-Farber Cancer Institute.