Docetaxel and Flavopiridol in Treating Patients With Refractory Metastatic Pancreatic Cancer
Condition: Adenocarcinoma of the Pancreas; Recurrent Pancreatic Cancer; Stage IV Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Intervention: alvocidib; docetaxel
Intervention description: Given IV; Given IV
Intervention MeSH terms: Docetaxel; Alvocidib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Drugs used in chemotherapy, such as docetaxel and flavopiridol, 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.
      Flavopiridol may also help docetaxel work better by making tumor cells more sensitive to the
      drug. This phase II trial is studying how well giving docetaxel followed by flavopiridol
      works in treating patients with refractory metastatic pancreatic cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed adenocarcinoma of the pancreas

               -  Evidence of metastatic disease

          -  Measurable disease, defined as ≥ 1 lesion that can be accurately measured in ≥ 1
             dimension (longest diameter to be recorded) as ≥ 20mm with conventional techniques or
             as ≥ 10 mm with spiral CT scan

               -  The primary site is not a measurable lesion

          -  Documented progression with measurable metastatic disease including any 1 of the
             following criteria:

               -  Receiving adjuvant therapy for resected disease

               -  Receiving therapy for locally advanced disease

               -  Within 3 months of completing adjuvant therapy or therapy for locally advanced
                  disease

               -  On 1 prior regimen in the metastatic setting

          -  No documented brain metastases

          -  Karnofsky performance status (PS) 80-100% OR ECOG PS 0-1

          -  WBC ≥ 2,500/mm³

          -  Absolute neutrophil count ≥ 1,500/mm³

          -  Platelet count ≥ 100,000/mm³

          -  Bilirubin ≤ 1.5 times upper limit of normal (ULN)

          -  AST and ALT < 2.5 times ULN

          -  Creatinine normal OR creatinine clearance ≥ 60 mL/min

          -  Alkaline phosphatase ≤ 5 times ULN

          -  No history of allergic reactions to compounds of similar chemical orbiological
             composition to flavopiridol

          -  No known allergy to docetaxel or medications formulated in polysorbate 80 (Tween 80)

          -  No uncontrolled diabetes

          -  No uncontrolled intercurrent illness including, but not limited to any of the
             following:

               -  Ongoing or active infection

               -  Symptomatic congestive heart failure

               -  Unstable angina pectoris

               -  Cardiac arrhythmia or myocardial infarction within the past 6 months

                    -  Rate-controlled atrial fibrillation stable for ≥ 6 months allowed

               -  Psychiatric illness or social situations that would limit compliance with study
                  requirements

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception during and for 3 months after
             completion of study treatment

          -  No peripheral neuropathy > grade 1

          -  No immune deficiency

          -  Atl east 2 weeks since prior chemotherapy (6 weeks for nitrosoureas, carmustine, or
             mitomycin C) and recovered

          -  At least 2 weeks since prior targeted therapy (e.g., antiangiogenic therapy [e.g.,
             bevacizumab] or epidermal growth factor receptor [EGFR] tyrosine kinase inhibitor
             [e.g., erlotinib hydrochloride]) and recovered

          -  At least 4 weeks since prior radiation therapy

          -  No prior docetaxel or flavopiridol

          -  No other concurrent chemotherapy or investigational agents

          -  No other concurrent anticancer agents or therapies

          -  No concurrent commonly used vitamins, antioxidants, orherbal preparations or
             supplements

               -  Single-tablet multivitamin allowed

          -  No concurrent combination antiretroviral therapy for HIV-positive patients