Capecitabine and Docetaxel in Treating Patients With Recurrent or Progressive Metastatic Pancreatic Cancer
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Intervention: Capecitabine; Docetaxel
Intervention description: 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
Intervention MeSH terms: Docetaxel; Capecitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 45.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: recurrent pancreatic cancer; adenocarcinoma of the pancreas; stage IV pancreatic cancer

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Participants or their authorized legally acceptable representative must consent to be
             in the study and must have signed and dated an approved consent form which conforms to
             federal and institutional guidelines.

          2. Patients must be 18 years or older.

          3. Participants must have recurrence or progression of histologically or cytologically
             documented pancreatic adenocarcinoma. Re-documentation of tumor histology or cytology
             prior to protocol therapy is not required if documented tumor was confirmed prior to
             initial therapy.

          4. Patients must have metastatic disease.

          5. Patients with metastatic disease to the brain if they have received radiation therapy
             or are stable, and are not receiving steroids or anticonvulsants.

          6. Participants must have received one prior gemcitabine based chemotherapy regimen (with
             or without radiation therapy). Participants must be 3 weeks or more beyond completion
             of prior chemotherapy (30 days beyond any experimental agent) and show recovery from
             toxicity to within the eligibility parameters of this protocol.

          7. Radiation for palliation and of the primary tumor must have been completed at least
             four weeks prior to initiation of protocol therapy.

          8. Patients must have measurable tumor by Response Evaluation Criteria in Solid Tumors
             (RECIST) (Therasse et al, 2000). Measurable disease includes any lesion ≥ 1 cm by
             spiral CT or ≥ 2 cm by non-spiral CT in longest diameter which can be repetitively
             assessed by radiographic measurement or any lesion ≥ 2 cm in longest diameter which
             can be repetitively assessed by physical examination. Positive bone scans,
             osteoblastic or osteolytic bone lesions, pleural effusions and positive bone marrow
             biopsies are not considered acceptable as either measurable or evaluable lesions.

          9. Participants must have Eastern Cooperative Oncology Group (ECOG) Performance Status
             Score of 0,1, or 2.

         10. Females of reproductive potential must not plan on conceiving children during the
             treatment period and must agree to use an effective medically accepted form of
             contraception. Patients will agree to continue contraception for 60 days from the date
             of the last study drug administration.

         11. Required initial laboratory data:

               -  Granulocytes ≥ 1,500/µl

               -  Platelets ≥ 100,000/µl

               -  Hg ≥ 8.0 g/dL

               -  Creatinine ≤ 2.0 mg/dL

               -  Creatine Clearance >30 ml/min as calculated with Cockroft-Gault equation

               -  Bilirubin ≤ Upper Limits of Normal (ULN)

               -  Pregnancy test for females with child-bearing potential: Negative within 7 days
                  of starting protocol

         12. Transaminases (SGOT and/or SGPT) may be up to 2.5 x institutional upper limit of
             normal (ULN) if alkaline phosphatase is ≤ ULN, or alkaline phosphatase may be up to 4
             x ULN if transaminases are ≤ ULN.

        Exclusion Criteria:

          1. Patient currently enrolled in another clinical trial.

          2. Pregnant or breast feeding women. With the exception of post-menopausal or infertile
             women, a negative blood test for pregnancy is mandatory before entry on study. Fertile
             persons refusing to use contraceptives may not participate.

          3. Participants may not have had capecitabine or docetaxel as part of prior therapy.

          4. No concurrent clinically evident malignancy is allowed except inactive non-melanoma
             skin cancer, low grade low stage bladder carcinoma followed off therapy, treated
             in-situ cervical cancer or lobular neoplasia of the breast.

          5. Participants with serious uncontrolled medical or psychiatric illness that would
             render chemotherapy unsafe are ineligible.

          6. Pregnant or breast-feeding at the time of proposed study entry.

          7. Clinical AIDS or known positive HIV serology.

          8. Peripheral neuropathy > grade 1

          9. Patients with a history of severe hypersensitivity reaction to drugs formulated with
             polysorbate 80 must be excluded.

         10. Prior unanticipated severe reaction to fluoropyrimidine therapy, or known sensitivity
             to 5-fluorouracil.

         11. Clinically significant cardiac disease (e.g. congestive heart failure, symptomatic
             coronary artery disease and cardiac arrhythmias not well controlled with medication)
             or myocardial infarction within the last 12 months.

         12. Lack of physical integrity of the upper gastrointestinal tract or malabsorption
             syndrome.

         13. Major Surgery within 4 weeks of the start of study treatment, without complete
             recovery.

         14. Unwillingness to participate or inability to comply with the protocol for the duration
             of the study.

         15. Patients with impaired renal function (estimated creatinine clearance < 30 ml/min as
             calculated by the Cockroft-Gault Equation).