NCT00331682

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 30, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 31, 2006

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
5.7 years until next milestone

Results Posted

Study results publicly available

January 10, 2014

Completed
Last Updated

May 28, 2014

Status Verified

November 1, 2013

Enrollment Period

2.2 years

First QC Date

May 30, 2006

Results QC Date

November 21, 2013

Last Update Submit

May 12, 2014

Conditions

Adenocarcinoma of the PancreasRecurrent Pancreatic CancerStage IV Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

  • Objective Response Rate as Measured by RECIST Criteria

    Objective response rate as measured by RECIST criteria

    Up to 2 years

Secondary Outcomes (2)

  • Time to Progression

    Between the start of treatment until the criteria for progression are met, assessed up to 2 years

  • Overall Survival

    Between the start of treatment until patient death, assessed up to 2 years

Study Arms (1)

Treatment (docetaxel and alvocidib)

EXPERIMENTAL

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: alvocidibDrug: docetaxel

Interventions

alvocidibDRUG

Given IV

Also known as: FLAVO, flavopiridol, HMR 1275, L-868275
Treatment (docetaxel and alvocidib)
docetaxelDRUG

Given IV

Also known as: RP 56976, Taxotere, TXT
Treatment (docetaxel and alvocidib)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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)
  • +27 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

alvocidibDocetaxel

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Results Point of Contact

Title
Dr. Eileen O'Reilly
Organization
Memorial Sloan-Kettering Cancer Center
oreillye@mskcc.org
646-888-4182

Study Officials

  • Eileen O'Reilly

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 30, 2006

First Posted

May 31, 2006

Study Start

March 1, 2006

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

May 28, 2014

Results First Posted

January 10, 2014

Record last verified: 2013-11

Locations

US(1)