Capecitabine and Oxaliplatin in Patients With Advanced or Metastatic Pancreatic Adenocarcinoma

Pancreatic Cancer Clinical Trial

Official title:

Capecitabine and Oxaliplatin in Patients With Advanced or Metastatic Pancreatic Adenocarcinoma

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00585078
• Other study ID #: 03-398
• Secondary ID: OX-03-033
• Status: Active, not recruiting
• Phase: Phase 2
• First received: December 24, 2007
• Last updated: February 23, 2017
• Start date: April 2004
• Est. completion date: November 2017

Study information

• Verified date: February 2017
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 37
• Est. completion date: November 2017
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• Capecitabine
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

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center	Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the response rate to capecitabine and oxaliplatin in patients with locally advanced or metastatic pancreatic adenocarcinoma		4 years
Secondary	To determine the safety of capecitabine and oxaliplatin in patients with locally advanced or metastatic pancreatic adenocarcinoma		4 years
Secondary	To determine the overall survival of patients treated with capecitabine and oxaliplatin in this patient population		TBD
Secondary	To determine the time to progression for patients treated with capecitabine and oxaliplatin in this patient population		TBD