Capecitabine and Oxaliplatin in Patients With Advanced or Metastatic Pancreatic Adenocarcinoma

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Rebecca Miksad, MD, MPH, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00585078
First received: December 24, 2007
Last updated: February 3, 2014
Last verified: February 2014
  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 advanced pancreatic cancer.


Condition Intervention Phase
Pancreatic Cancer
Drug: Capecitabine
Drug: Oxaliplatin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Capecitabine and Oxaliplatin in Patients With Advanced or Metastatic Pancreatic Adenocarcinoma

Resource links provided by NLM:


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 Study Completion Date: July 2014
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment
Capecitabine and Oxaliplatin
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.
Other Name: Xeloda
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00585078

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Sanofi
Investigators
Principal Investigator: Rebecca Miksad, MD, MPH Beth Israel Deaconess Medical Center
  More Information

No publications provided

Responsible Party: Rebecca Miksad, MD, MPH, Assistant Professor, Harvard University; Attending Physician, Beth Israel Deaconess Medical Center, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00585078     History of Changes
Other Study ID Numbers: 03-398, OX-03-033
Study First Received: December 24, 2007
Last Updated: February 3, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:
capecitabine
oxaliplatin

Additional relevant MeSH terms:
Adenocarcinoma
Pancreatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Oxaliplatin
Capecitabine
Fluorouracil
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 24, 2014