Capecitabine and Docetaxel in Treating Patients With Recurrent or Progressive Metastatic Pancreatic Cancer

Brief summary public domain (ClinicalTrials.gov)

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 public domain (ClinicalTrials.gov)

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.

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Rate of Participants Achieving Complete Response or Partial Response to Therapy. [Up to 1 year]. Number, participants. Partial Response (PR) >= 2 cycles: CapTere (Capecitabine + Docetaxel) (n=42): 6. Stable Disease (SD), >= 2 cycles: CapTere (Capecitabine + Docetaxel) (n=42): 25. Complete Response (CR), >= 2 cycles: CapTere (Capecitabine + Docetaxel) (n=42): 0.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Overall Surival (OS) [Up to 1 year]. Median, months (95% Confidence Interval). CapTere (Capecitabine + Docetaxel) (n=42): 5.3 (4.3 to 8.6).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Progression-free Survival (PFS) [Up to 1 year]. Median, months (95% Confidence Interval). CapTere (Capecitabine + Docetaxel) (n=42): 3.7 (2.1 to 4.3).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Rate of Participants Achieving a 50% or More Reduction in CA 19-9 Levels [Up to 1 year]. Number, percentage of participants. CapTere (Capecitabine + Docetaxel) (n=31): 35.48.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Number of Study Participants Experiencing Toxicity After Receiving Protocol Therapy [Up to 1 year]. Number, participants. CapTere (Capecitabine + Docetaxel) (n=43): 38.