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Capecitabine and Oxaliplatin in Patients With Advanced or Metastatic Pancreatic Adenocarcinoma
This study is currently recruiting participants.
Verified by Dana-Farber Cancer Institute, January 2009
Sponsors and Collaborators: Beth Israel Deaconess Medical Center
Sanofi-Aventis
Information provided by: Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00585078
  Purpose

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 pancreatic cancer.


Condition Intervention Phase
Pancreatic Cancer
Drug: Capecitabine
Drug: Oxaliplatin
Phase II

MedlinePlus related topics: Cancer Pancreatic Cancer
Drug Information available for: Capecitabine Oxaliplatin
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title: Capecitabine and Oxaliplatin in Patients With Advanced or Metastatic Pancreatic Adenocarcinoma

Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • To determine the response rate to capecitabine and oxaliplatin in patients with locally advanced or metastatic pancreatic adenocarcinoma [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine the safety of capecitabine and oxaliplatin in patients with locally advanced or metastatic pancreatic adenocarcinoma [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  • To determine the overall survival of patients treated with capecitabine and oxaliplatin in this patient population [ Time Frame: TBD ] [ Designated as safety issue: No ]
  • To determine the time to progression for patients treated with capecitabine and oxaliplatin in this patient population [ Time Frame: TBD ] [ Designated as safety issue: No ]

Estimated Enrollment: 37
Study Start Date: April 2004
Estimated Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
    Drug: Oxaliplatin
    Given on Day 1 of each 3-week cycle
Detailed 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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00585078

Contacts
Contact: Sanjay Jain, MD 6170667-9236

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Sanofi-Aventis
Investigators
Principal Investigator: Sanjay Jain, MD Beth Israel Deaconess Medical Center
  More Information

Responsible Party: Beth Israel Deaconess Medical Center ( Sanjay Jain, MD )
Study ID Numbers: 03-398, OX-03-033
Study First Received: December 24, 2007
Last Updated: January 6, 2009
ClinicalTrials.gov Identifier: NCT00585078  
Health Authority: United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:
capecitabine
oxaliplatin

Study placed in the following topic categories:
Capecitabine
Digestive System Neoplasms
Pancreatic Neoplasms
Endocrine System Diseases
Carcinoma
Oxaliplatin
Digestive System Diseases
Gastrointestinal Neoplasms
Pancreatic Diseases
Endocrinopathy
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Antimetabolites
Neoplasms
Antimetabolites, Antineoplastic
Neoplasms by Site
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009