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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
45
Orally, 1600mg/m2/day given as (800mg/m2 BID), Days 1 through 14 of 21-day cycle
30 mg/m2, IV, days 1 and 8 every 3 weeks
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States
University of Miami
Miami, Florida, United States
Mount Sinai Comprehensive Cancer Center at Mount Sinai Medical Center
Miami Beach, Florida, United States
Rate of Participants Achieving Complete Response or Partial Response to Therapy.
Rate of participants achieving complete response (CR) or partial response (PR) to Captere therapy according to RECIST criteria v 1.0. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions.
Time frame: Up to 1 year
Overall Surival (OS)
Overall survival is measured from the time from date of initial protocol therapy to date of death. In the absence of confirmation of death, survival time will be censored to last date of follow-up.
Time frame: Up to 1 year
Progression-free Survival (PFS)
Progression-free survival (PFS) is measured the time from the start of protocol therapy to disease progression or death from any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time frame: Up to 1 year
Rate of Participants Achieving a 50% or More Reduction in CA 19-9 Levels
Rate of participants achieving a 50% or more reduction in CA 19-9 levels after receiving protocol therapy. Baseline CA-19-9 will be compared to the lowest recorded value on patients receiving therapy on protocol. A 50% drop in CA 19-9 in patients with baseline levels above 100 U/ml will be recorded as a CA 19-9 response if the \> 50% drop can be confirmed with at least one more CA 19-9 level thereafter with \> 50% drop compared to baseline.
Time frame: Up to 1 year
Number of Study Participants Experiencing Toxicity After Receiving Protocol Therapy
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Number of study participants experiencing toxicity (serious adverse events or adverse events). Study participants assessed for this outcome measure must have received at least one dose of protocol therapy. Toxicity assessed according to Common Terminology Criteria for Adverse Events v3.0 (CTCAE).
Time frame: Up to 1 year