Clinical trial NCT00331682 (phase 2, status: completed)
Conditions: adenocarcinoma of the pancreas, recurrent pancreatic cancer, stage iv pancreatic cancer
ICD codes: C22.0, C22.1, C4A.9, C7B.1, D09.9, C4A.0, C4A.31, C25.3, C25.3
Drugs: alvocidib, docetaxel
SMILES: CN1CC[C@@H]([C@H](O)C1)C1=C(O)C=C(O)C2=C1OC(=CC2=O)C1=CC=CC=C1Cl, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
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