Conditions: Pancreatic Cancer
Keywords: recurrent pancreatic cancer adenocarcinoma of the pancreas stage IV pancreatic cancer
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 45
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: Capecitabine + Docetaxel (Taxotere)

Interventions: intervention 1: Capecitabine intervention 2: Docetaxel
Intervention descriptions: intervention 1: Orally, 1600mg/m2/day given as (800mg/m2 BID), Days 1 through 14 of 21-day cycle intervention 2: 30 mg/m2, IV, days 1 and 8 every 3 weeks

Protocol document: