Docetaxel and Flavopiridol in Treating Patients With Refractory Metastatic Pancreatic Cancer
Adenocarcinoma of the Pancreas, Recurrent Pancreatic Cancer, Stage IV Pancreatic Cancer
About this trial
This is an interventional treatment trial for Adenocarcinoma of the Pancreas
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
Sites / Locations
- Memorial Sloan-Kettering Cancer Center
Arms of the Study
Arm 1
Experimental
Treatment (docetaxel and alvocidib)
Patients receive docetaxel IV over 30 minutes followed 4-6 hours later by flavopiridol IV over 60 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.