Capecitabine and Docetaxel in Treating Patients With Recurrent or Progressive Metastatic Pancreatic Cancer
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.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Multicenter Phase II Study of Capecitabine and Docetaxel for Previously Treated Pancreatic Cancer Patients "CapTere"|
- Number of Participant Achieving Complete Response or Partial Response to Therapy. [ Time Frame: 1 year ] [ Designated as safety issue: No ]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.
- Number of Participants Achieving a 50% or More Reduction in CA 19-9 Levels [ Time Frame: 1 year ] [ Designated as safety issue: No ]Number 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 to Progression as Measured by the Kaplan Meyer Curve [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Toxicity as Collected Through Protocol Execution [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
|Study Start Date:||June 2004|
|Study Completion Date:||June 2010|
|Primary Completion Date:||August 2008 (Final data collection date for primary outcome measure)|
Experimental: CapTere (Capecitabine + Docetaxel)
Capecitabine + Docetaxel (Taxotere)
Orally, 1600mg/m2/day given as (800mg/m2 BID), Days 1 through 14 of 21-day cycle
Other Name: XelodaDrug: Docetaxel
30 mg/m2, IV, days 1 and 8 every 3 weeks
Other Name: Taxotere
- 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 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.
|United States, Florida|
|Mayo Clinic - Jacksonville|
|Jacksonville, Florida, United States, 32224|
|University of Miami Sylvester Comprehensive Cancer Center - Miami|
|Miami, Florida, United States, 33136|
|Mount Sinai Comprehensive Cancer Center at Mount Sinai Medical Center|
|Miami Beach, Florida, United States, 33140|
|Study Chair:||Caio Max S. Rocha Lima, MD||University of Miami Sylvester Comprehensive Cancer Center|