A Multicenter Phase II Study of Capecitabine and Docetaxel for Previously Treated Pancreatic Cancer Patients "CapTere"
- Determine the overall (complete and partial) response rate in patients with recurrent
or progressive metastatic pancreatic cancer treated with capecitabine and docetaxel.
- Determine the overall and progression-free survival of patients treated with the
- Determine the duration of response (complete or partial) among patients who attain a
- 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
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
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.
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Participant Achieving Complete Response or Partial Response to Therapy.
Number 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.
Caio Max S. Rocha Lima, MD
University of Miami Sylvester Comprehensive Cancer Center
United States: Food and Drug Administration
|Mayo Clinic - Jacksonville||Jacksonville, Florida 32224|
|University of Miami Sylvester Comprehensive Cancer Center - Miami||Miami, Florida 33136|
|Mount Sinai Comprehensive Cancer Center at Mount Sinai Medical Center||Miami Beach, Florida 33140|