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Docetaxel and Flavopiridol in Treating Patients With Refractory Metastatic Pancreatic Cancer
This study has been completed.
Sponsors and Collaborators: Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00331682
  Purpose

RATIONALE: 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.

PURPOSE: This phase II trial is studying how well giving docetaxel followed by flavopiridol works in treating patients with refractory metastatic pancreatic cancer.


Condition Intervention Phase
Pancreatic Cancer
Drug: alvocidib
Drug: docetaxel
Phase II

MedlinePlus related topics: Cancer Pancreatic Cancer
Drug Information available for: Docetaxel Pancrelipase Ultrase Alvocidib Flavopiridol
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label
Official Title: An Open-Label, Non-Randomized Phase II Study of Flavopiridol in Combination With Docetaxel in Refractory, Metastatic Pancreatic Cancer

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Objective response rate as measured by RECIST criteria [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to progression as measured by Kaplan-Meier [ Designated as safety issue: No ]
  • Overall survival as measured by Kaplan-Meier [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: March 2006
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Determine the response rate in patients with refractory, metastatic pancreatic cancer treated with weekly, sequential docetaxel and flavopiridol.

Secondary

  • Determine the time to progression and overall survival of patients treated with this regimen.
  • Assess the toxicity of this regimen.

OUTLINE: This is a non-randomized, open-label, prospective study.

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.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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 ≥ 20 mm 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

PATIENT CHARACTERISTICS:

  • 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 or biological 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

PRIOR CONCURRENT THERAPY:

  • At least 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, or herbal preparations or supplements

    • Single-tablet multivitamin allowed
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00331682

Locations
United States, New York
Memorial Sloan - Kettering Cancer Center
New York, New York, United States, 10021-0009
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Study Chair: Eileen O'Reilly, MD Memorial Sloan-Kettering Cancer Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000472413, MSKCC-05136, NCI-6366
Study First Received: May 30, 2006
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00331682  
Health Authority: United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):
recurrent pancreatic cancer
adenocarcinoma of the pancreas
stage IV pancreatic cancer

Study placed in the following topic categories:
Digestive System Neoplasms
Pancreatic Neoplasms
Endocrine System Diseases
Pancrelipase
Recurrence
Docetaxel
Flavopiridol
Digestive System Diseases
Gastrointestinal Neoplasms
Pancreatic Diseases
Endocrinopathy
Adenocarcinoma
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Growth Substances
Therapeutic Uses
Physiological Effects of Drugs
Enzyme Inhibitors
Growth Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009