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Docetaxel and Flavopiridol in Treating Patients With Refractory Metastatic Pancreatic Cancer

Primary Purpose

Adenocarcinoma of the Pancreas, Recurrent Pancreatic Cancer, Stage IV Pancreatic Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
alvocidib
docetaxel
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adenocarcinoma of the Pancreas

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Experimental

Arm Label

Treatment (docetaxel and alvocidib)

Arm Description

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.

Outcomes

Primary Outcome Measures

Objective Response Rate as Measured by RECIST Criteria
Objective response rate as measured by RECIST criteria

Secondary Outcome Measures

Time to Progression
Will be computed using Kaplan-Meier methods.
Overall Survival
Will be computed using Kaplan-Meier methods.

Full Information

First Posted
May 30, 2006
Last Updated
May 12, 2014
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00331682
Brief Title
Docetaxel and Flavopiridol in Treating Patients With Refractory Metastatic Pancreatic Cancer
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 Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenocarcinoma of the Pancreas, Recurrent Pancreatic Cancer, Stage IV Pancreatic Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (docetaxel and alvocidib)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
alvocidib
Other Intervention Name(s)
FLAVO, flavopiridol, HMR 1275, L-868275
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
docetaxel
Other Intervention Name(s)
RP 56976, Taxotere, TXT
Intervention Description
Given IV
Primary Outcome Measure Information:
Title
Objective Response Rate as Measured by RECIST Criteria
Description
Objective response rate as measured by RECIST criteria
Time Frame
Up to 2 years
Secondary Outcome Measure Information:
Title
Time to Progression
Description
Will be computed using Kaplan-Meier methods.
Time Frame
Between the start of treatment until the criteria for progression are met, assessed up to 2 years
Title
Overall Survival
Description
Will be computed using Kaplan-Meier methods.
Time Frame
Between the start of treatment until patient death, assessed up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eileen O'Reilly
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Docetaxel and Flavopiridol in Treating Patients With Refractory Metastatic Pancreatic Cancer

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