Docetaxel and Flavopiridol in Treating Patients With Refractory Metastatic Pancreatic Cancer

Completed · Phase 2

Conditions studied: Adenocarcinoma of the Pancreas, Recurrent Pancreatic Cancer, Stage IV Pancreatic Cancer

In brief

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.

Key facts

Study ID

NCT00331682

Run by

National Cancer Institute (NCI)

People needed

10

Starts

2006-03-01

Expected to finish

2008-05-01

Last updated by the study team

2014-05-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• Memorial Sloan-Kettering Cancer Center — New York, New York, United States

Full record on ClinicalTrials.gov

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