NCT00216138

Brief Summary

Recent progress in treatment of recurrent/metastatic SCCHN has been made with the introduction of the taxanes. Docetaxel as a single agent has a response rate of 22-42% and 17% in patients with recurrent disease. Capecitabine is an oral fluoropyrimidine prodrug that is converted into 5-FU. Previous studies have shown that the capecitabine/docetaxel combination has a synergistic inhibition of tumor growth, resulting in significantly superior efficacy in time to disease progression (TTP), overall survival, median survival and objective tumor response rate compared to docetaxel alone. This trial will investigate the efficacy the combination of docetaxel and capecitabine in treating patients with recurrent/metastatic SCCHN.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for phase_2 head-and-neck-cancer

Timeline
Completed

Started Mar 2004

Geographic Reach
1 country

18 active sites

Status
terminated

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, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

May 2, 2011

Status Verified

April 1, 2011

Enrollment Period

3.5 years

First QC Date

September 12, 2005

Last Update Submit

April 28, 2011

Conditions

Head and Neck Cancer

Keywords

Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

  • - To assess response rate in a group of patients receiving combination therapy with docetaxel and capecitabine

    24 months

Secondary Outcomes (5)

  • To assess toxicity of the combination

    24 months

  • To determine whether the status of calpain, calpain activation,(EGFR) expression, Cox-2 expression, TS, TP, DPD, and/or CYP3A4/CYP3A5 will predict treatment

    24 months

  • Efficacy and safety analyses on special sub-cohorts

    24 months

  • To determine the progression free survival and overall survival

    24 months

  • To assess change in analgesic usage with this protocol therapy

    24 months

Study Arms (1)

1

ACTIVE COMPARATOR

Docetaxel + Capecitabine

Drug: DocetaxelDrug: CapecitabineDrug: Premedication

Interventions

DocetaxelDRUG

Docetaxel 60 mg/m2 for 60 minutes, day 1 of each cycle

1
CapecitabineDRUG

Capecitabine 825 mg/m2 po bid, days 1-14

1
PremedicationDRUG

Dexamethasone and antiemetic premedication

1

Eligibility Criteria

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

You may qualify if:

  • Histologically confirmed recurrent or metastatic squamous cell carcinoma of the head and neck.
  • Recurrent/metastatic disease not amenable to surgery or salvage chemoradiation.
  • Unidimensional measurable disease according to the RECIST
  • In-field recurrence, within a prior radiation field only, distant metastatic disease
  • Both in-field and metastatic sites of disease will require evaluation by a Radiation Oncologist to consider local radiation therapy first and will be eligible for possible enrollment one month after completion of the radiation therapy.
  • Negative pregnancy test
  • Patients may have received prior chemotherapy as part of chemoradiation or induction chemotherapy for initial treatment of disease confined to the head and neck region - Patients must have fully recovered from any prior radiation therapy

You may not qualify if:

  • Patients who have relapsed \< 6 months after completing a combined modality curative treatment that included a fluoropyrimidine or taxanes
  • No brain metastases
  • No major neurological disease, including stroke
  • No prior chemotherapy regimen for recurrent/metastatic disease
  • No prior history of capecitabine usage
  • No prior history of docetaxel usage except in the induction setting for head and neck cancer which has been completed for greater than 6 months prior to beginning protocol therapy
  • No past hypersensitivity to taxanes or 5 FU
  • No hypersensitivity to docetaxel or other drugs formulated with polysorbate 80
  • No current use of warfarin
  • Patients must not be receiving ketoconazole, midazolam, erythromycin, orphenadrine, troleandomycin, cyclosporine or antiepileptics
  • Patients must not be treated with any of the following on protocol therapy or within 28 days prior to beginning protocol therapy: sorivudine, brivudine, cimetidine, allopurinol
  • Patients must have fully recovered from any prior surgery
  • No known HIV seropositivity.
  • No serious uncontrolled medical condition, uncontrolled peptic ulcer disease or malabsorption syndrome
  • No peripheral neuropathy \> grade 1
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Helen F. Graham Cancer Center

Newark, Delaware, 19713, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Elkhart Clinic

Elkhart, Indiana, 46515, United States

Location

Oncology Hematology Associates of SW Indiana

Evansville, Indiana, 47714, United States

Location

Fort Wayne Oncology & Hematology, Inc

Fort Wayne, Indiana, 46815, United States

Location

Center for Cancer Care at Goshen Health System

Goshen, Indiana, 46527, United States

Location

Indiana University Cancer Center

Indianapolis, Indiana, 46202, United States

Location

Quality Cancer Center (MCGOP)

Indianapolis, Indiana, 46202, United States

Location

Arnett Cancer Care

Lafayette, Indiana, 47904, United States

Location

Medical Consultants, P.C.

Muncie, Indiana, 47303, United States

Location

Center for Cancer Care, Inc., P.C.

New Albany, Indiana, 47150, United States

Location

Northern Indiana Cancer Research Consortium

South Bend, Indiana, 46601, United States

Location

Providence Medical Group

Terre Haute, Indiana, 47802, United States

Location

AP&S Clinic

Terre Haute, Indiana, 47804, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Center for Hematology-Oncology of S Michigan

Jackson, Michigan, 49201, United States

Location

Siteman Cancer Center

St Louis, Missouri, 63110, United States

Location

Methodist Cancer Center

Omaha, Nebraska, 68114, United States

Location

Related Links

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

DocetaxelCapecitabinePremedication

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesDrug TherapyTherapeutics

Study Officials

  • David Potter, M.D.

    Hoosier Oncology Group, LLC

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 22, 2005

Study Start

March 1, 2004

Primary Completion

September 1, 2007

Study Completion

September 1, 2007

Last Updated

May 2, 2011

Record last verified: 2011-04

Locations

US(18)