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Docetaxel and Flavopiridol in Treating Patients With Refractory Metastatic Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT00331682
Recruitment Status : Completed
First Posted : May 31, 2006
Results First Posted : January 10, 2014
Last Update Posted : May 28, 2014
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Brief 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.

Condition or disease Intervention/treatment Phase
Adenocarcinoma of the Pancreas Recurrent Pancreatic Cancer Stage IV Pancreatic Cancer Drug: alvocidib Drug: docetaxel Phase 2

Detailed Description:

PRIMARY OBJECTIVES:

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

SECONDARY OBJECTIVES:

I. Determine the time to progression and overall survival of patients treated with this regimen.

II. 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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Non-Randomized Phase II Study of Alvocidib (Flavopiridol) in Combination With Docetaxel in Refractory, Metastatic Pancreatic Cancer (NCI #6366)
Study Start Date : March 2006
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Docetaxel

Arm Intervention/treatment
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.
Drug: alvocidib
Given IV
Other Names:
  • FLAVO
  • flavopiridol
  • HMR 1275
  • L-868275

Drug: docetaxel
Given IV
Other Names:
  • RP 56976
  • Taxotere
  • TXT




Primary Outcome Measures :
  1. Objective Response Rate as Measured by RECIST Criteria [ Time Frame: Up to 2 years ]
    Objective response rate as measured by RECIST criteria


Secondary Outcome Measures :
  1. Time to Progression [ Time Frame: Between the start of treatment until the criteria for progression are met, assessed up to 2 years ]
    Will be computed using Kaplan-Meier methods.

  2. Overall Survival [ Time Frame: Between the start of treatment until patient death, assessed up to 2 years ]
    Will be computed using Kaplan-Meier methods.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00331682


Locations
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United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Eileen O'Reilly Memorial Sloan Kettering Cancer Center

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Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00331682     History of Changes
Other Study ID Numbers: NCI-2012-01471
05-136
MSKCC-05136
NCI-6366
CDR0000472413
R01CA067819 ( U.S. NIH Grant/Contract )
First Posted: May 31, 2006    Key Record Dates
Results First Posted: January 10, 2014
Last Update Posted: May 28, 2014
Last Verified: November 2013
Additional relevant MeSH terms:
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Adenocarcinoma
Pancreatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Docetaxel
Alvocidib
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Growth Inhibitors
Growth Substances
Physiological Effects of Drugs
Protein Kinase Inhibitors
Enzyme Inhibitors