Capecitabine and Docetaxel in Treating Patients With Recurrent or Progressive Metastatic Pancreatic Cancer
|ClinicalTrials.gov Identifier: NCT00290693|
Recruitment Status : Completed
First Posted : February 13, 2006
Results First Posted : May 13, 2013
Last Update Posted : December 2, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Drug: Capecitabine Drug: Docetaxel||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||45 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter Phase II Study of Capecitabine and Docetaxel for Previously Treated Pancreatic Cancer Patients "CapTere"|
|Actual Study Start Date :||July 2004|
|Actual Primary Completion Date :||August 2008|
|Actual Study Completion Date :||June 2010|
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
- Rate of Participants Achieving Complete Response or Partial Response to Therapy. [ Time Frame: Up to 1 year ]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.
- Overall Surival (OS) [ Time Frame: Up to 1 year ]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.
- Progression-free Survival (PFS) [ Time Frame: Up to 1 year ]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.
- Rate of Participants Achieving a 50% or More Reduction in CA 19-9 Levels [ Time Frame: Up to 1 year ]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.
- Number of Study Participants Experiencing Toxicity After Receiving Protocol Therapy [ Time Frame: Up to 1 year ]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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00290693
|United States, Florida|
|Mayo Clinic - Jacksonville|
|Jacksonville, Florida, United States, 32224|
|Mount Sinai Comprehensive Cancer Center at Mount Sinai Medical Center|
|Miami Beach, Florida, United States, 33140|
|University of Miami|
|Miami, Florida, United States, 33136|
|Principal Investigator:||Caio Max S. Rocha Lima, MD||University of Miami|