Pancreatic Cancer Clinical Trial
Official title:
A Multicenter Phase II Study of Capecitabine and Docetaxel for Previously Treated Pancreatic Cancer Patients "CapTere"
RATIONALE: Drugs used in chemotherapy, such as capecitabine and docetaxel, work in different
ways to stop the growth of tumor cells, either by killing the cells or by stopping them from
dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving capecitabine together with docetaxel
works in treating patients with recurrent or progressive metastatic pancreatic cancer.
OBJECTIVES:
Primary
- Determine the overall (complete and partial) response rate in patients with recurrent or
progressive metastatic pancreatic cancer treated with capecitabine and docetaxel.
Secondary
- Determine the overall and progression-free survival of patients treated with the
chemotherapy combination.
- Determine the duration of response (complete or partial) among patients who attain a
response.
- Determine the frequency of patients having > 50% fall of CA19-9 from an initial level of
> 100 U/mL in association with treatment with this regimen.
- Evaluate the toxicity associated with the administration of the combination in these
patients.
OUTLINE: This is a multicenter, open-label, nonrandomized study.
Patients receive oral capecitabine twice daily on days 1-14 and docetaxel IV over 1 hour on
days 1 and 8. Treatment repeats every 3 weeks in the absence of disease progression or
unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for up to 1 year.
PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study.
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