Docetaxel And Flavopiridol In Treating Patients With Refractory Metastatic Pancreatic Cancer

Study Overview

Docetaxel and Flavopiridol in Treating Patients With Refractory Metastatic Pancreatic Cancer

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.

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.

Adenocarcinoma of the Pancreas
Recurrent Pancreatic Cancer
Stage IV Pancreatic Cancer

DRUG: alvocidib
DRUG: docetaxel

NCI-2012-01471
05-136
MSKCC-05136
NCI-6366
CDR0000472413
R01CA067819 (U.S. NIH Grant/Contract)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2006-05-30	Results First Submitted 2013-11-21	Last Update Submitted that met QC Criteria 2014-05-12
First Submitted that Met QC Criteria 2006-05-30	Results First Submitted that Met QC Criteria 2013-11-21	Last Update Posted (ESTIMATED) 2014-05-28
First Posted (ESTIMATED) 2006-05-31	Results First Posted 2014-01-10	Last Verified 2013-11

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/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 DRUG: docetaxel Given IV

Participant Group/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

DRUG: docetaxel

Given IV

Primary Outcome Measures	Measure Description	Time Frame
Objective Response Rate as Measured by RECIST Criteria	Objective response rate as measured by RECIST criteria	Up to 2 years

Secondary Outcome Measures	Measure Description	Time Frame
Time to Progression	Will be computed using Kaplan-Meier methods.	Between the start of treatment until the criteria for progression are met, assessed up to 2 years
Overall Survival	Will be computed using Kaplan-Meier methods.	Between the start of treatment until patient death, assessed up to 2 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Eileen O'Reilly, Memorial Sloan Kettering Cancer Center

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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Clinical Trial Record