Docetaxel and Capecitabine for First Line Treatment of Metastatic Squamous Cell Carcinoma of the Head & Neck - Full Text View

Sponsor:	Hoosier Oncology Group
Collaborators:	Sanofi-Aventis Hoffmann-La Roche Walther Cancer Institute
Information provided by:	Hoosier Oncology Group
ClinicalTrials.gov Identifier:	NCT00216138

Purpose

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.

Condition	Intervention	Phase
Head and Neck Cancer	Drug: Docetaxel Drug: Capecitabine Drug: Premedication	Phase II

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Single Arm Phase II Trial of Docetaxel and Capecitabine for the First Line Treatment of Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN): Hoosier Oncology Group HN02-40

Resource links provided by NLM:

MedlinePlus related topics: Cancer Head and Neck Cancer

Drug Information available for: Docetaxel Capecitabine

U.S. FDA Resources

Further study details as provided by Hoosier Oncology Group:

Primary Outcome Measures:

- To assess response rate in a group of patients receiving combination therapy with docetaxel and capecitabine [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To assess toxicity of the combination [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
To determine whether the status of calpain, calpain activation,(EGFR) expression, Cox-2 expression, TS, TP, DPD, and/or CYP3A4/CYP3A5 will predict treatment [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Efficacy and safety analyses on special sub-cohorts [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
To determine the progression free survival and overall survival [ Time Frame: 24 months ] [ Designated as safety issue: No ]
To assess change in analgesic usage with this protocol therapy [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Enrollment:	19
Study Start Date:	March 2004
Study Completion Date:	September 2007
Primary Completion Date:	September 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Docetaxel + Capecitabine	Drug: Docetaxel Docetaxel 60 mg/m2 for 60 minutes, day 1 of each cycle Drug: Capecitabine Capecitabine 825 mg/m2 po bid, days 1-14 Drug: Premedication Dexamethasone and antiemetic premedication

Detailed Description:

OUTLINE: This is a multi-center study.

Dexamethasone and antiemetic premedication1.
Docetaxel: 60 mg/m2 for a 60 minute infusion day 1 of each cycle
Capecitabine: 825 mg/m2 po BID Days 1-14

Repeat every 21 days until tumor progression or toxicity that requires discontinuation of therapy

Performance status: ECOG performance status 0 or 1

Life expectancy: At least 3 months

Hematopoietic:

ANC of > 1,500/mm3
Platelets > 100,000/mm3
Hemoglobin > 8 gm/dl

Hepatic:

Total Bilirubin £ ULN
Albumin > 3
Maximum Alk Phos > 2.5 x < 5 x ULN

Renal:

Creatinine clearance of > 50 ml/ min (by Cockcroft-Gault)

Cardiovascular:

No decompensated congestive heart failure or active angina.
Clinically significant cardiac disease not well controlled with medication (eg. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias) or myocardial infarction in the past 12 months is not allowed.

Pulmonary:

Not specified

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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
Patients with a percutaneous gastrostomy (PEG) must be able take medications by tube.
No daily consumption of alcohol
No active infection
No prior history of malignancy in the last 5 years, excluding in situ carcinoma of the cervix or adequately treated basal or squamous cell carcinoma of the skin or Gleason Grade < VII organ confined prostate cancer.
No current breastfeeding

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00216138

Locations

United States, Delaware
Helen F. Graham Cancer Center
Newark, Delaware, United States, 19713
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
United States, Indiana
Arnett Cancer Care
Lafayette, Indiana, United States, 47904
Center for Cancer Care, Inc., P.C.
New Albany, Indiana, United States, 47150
Northern Indiana Cancer Research Consortium
South Bend, Indiana, United States, 46601
Fort Wayne Oncology & Hematology, Inc
Fort Wayne, Indiana, United States, 46815
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202
Medical Consultants, P.C.
Muncie, Indiana, United States, 47303
Elkhart Clinic
Elkhart, Indiana, United States, 46515
Oncology Hematology Associates of SW Indiana
Evansville, Indiana, United States, 47714
Quality Cancer Center (MCGOP)
Indianapolis, Indiana, United States, 46202
Center for Cancer Care at Goshen Health System
Goshen, Indiana, United States, 46527
AP&S Clinic
Terre Haute, Indiana, United States, 47804
Providence Medical Group
Terre Haute, Indiana, United States, 47802
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, Michigan
Center for Hematology-Oncology of S Michigan
Jackson, Michigan, United States, 49201
United States, Missouri
Siteman Cancer Center
St. Louis, Missouri, United States, 63110
United States, Nebraska
Methodist Cancer Center
Omaha, Nebraska, United States, 68114

Sponsors and Collaborators

Hoosier Oncology Group

Sanofi-Aventis

Hoffmann-La Roche

Walther Cancer Institute

Investigators

Study Chair:

David Potter, M.D.

Hoosier Oncology Group, LLC

More Information

Additional Information:

Hoosier Oncology Group Home Page This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Hoosier Oncology Group ( David Potter, M.D. )
Study ID Numbers:	HOG HN02-40
Study First Received:	September 12, 2005
Last Updated:	April 29, 2009
ClinicalTrials.gov Identifier:	NCT00216138 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Hoosier Oncology Group:

Head and Neck Cancer

Additional relevant MeSH terms:

Antimetabolites
Capecitabine
Antimetabolites, Antineoplastic
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Pharmacologic Actions
Carcinoma

Docetaxel
Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Therapeutic Uses
Neoplasms, Squamous Cell
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 30, 2009