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Capecitabine and Oxaliplatin in Patients With Advanced or Metastatic Pancreatic Adenocarcinoma

Phase 2
18 Years
Open (Enrolling)
Pancreatic Cancer

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Trial Information

Capecitabine and Oxaliplatin in Patients With Advanced or Metastatic Pancreatic Adenocarcinoma

- 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.

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

- 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

- 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

- Lack of physical integrity of the upper gastrointestinal tract or malabsorption

- Known, existing uncontrolled coagulopathy

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the response rate to capecitabine and oxaliplatin in patients with locally advanced or metastatic pancreatic adenocarcinoma

Outcome Time Frame:

4 years

Safety Issue:


Principal Investigator

Rebecca Miksad, MD, MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

Beth Israel Deaconess Medical Center


United States: Institutional Review Board

Study ID:




Start Date:

April 2004

Completion Date:

July 2013

Related Keywords:

  • Pancreatic Cancer
  • capecitabine
  • oxaliplatin
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Pancreatic Neoplasms



Beth Israel Deaconess Medical Center Boston, Massachusetts  02215