Clinical trial NCT00216138: Docetaxel and Capecitabine for First Line Treatment of Metastatic Squamous Cell Carcinoma of the Head & Neck
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Head and Neck Cancer
Keywords: Head and Neck Cancer
Lead sponsor: Hoosier Cancer Research Network
Sponsor class: OTHER
Collaborators: name: Sanofi
name: Hoffmann-La Roche
name: Walther Cancer Institute
First posted: 2005-09-22
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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 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

Primary outcomes:
measure: - To assess response rate in a group of patients receiving combination therapy with docetaxel and capecitabine
timeFrame: 24 months
Secondary outcomes:
measure: To assess toxicity of the combination
timeFrame: 24 months
measure: To determine whether the status of calpain, calpain activation,(EGFR) expression, Cox-2 expression, TS, TP, DPD, and/or CYP3A4/CYP3A5 will predict treatment
timeFrame: 24 months
measure: Efficacy and safety analyses on special sub-cohorts
timeFrame: 24 months
measure: To determine the progression free survival and overall survival
timeFrame: 24 months
measure: To assess change in analgesic usage with this protocol therapy
timeFrame: 24 months
Other outcomes:
Locations:
city: Newark
country: United States
facility: Helen F. Graham Cancer Center
state: Delaware
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Elkhart
country: United States
facility: Elkhart Clinic
state: Indiana
city: Evansville
country: United States
facility: Oncology Hematology Associates of SW Indiana
state: Indiana
city: Fort Wayne
country: United States
facility: Fort Wayne Oncology & Hematology, Inc
state: Indiana
city: Goshen
country: United States
facility: Center for Cancer Care at Goshen Health System
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University Cancer Center
state: Indiana
city: Indianapolis
country: United States
facility: Quality Cancer Center (MCGOP)
state: Indiana
city: Lafayette
country: United States
facility: Arnett Cancer Care
state: Indiana
city: Muncie
country: United States
facility: Medical Consultants, P.C.
state: Indiana
city: New Albany
country: United States
facility: Center for Cancer Care, Inc., P.C.
state: Indiana
city: South Bend
country: United States
facility: Northern Indiana Cancer Research Consortium
state: Indiana
city: Terre Haute
country: United States
facility: Providence Medical Group
state: Indiana
city: Terre Haute
country: United States
facility: AP&S Clinic
state: Indiana
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Jackson
country: United States
facility: Center for Hematology-Oncology of S Michigan
state: Michigan
city: St. Louis
country: United States
facility: Siteman Cancer Center
state: Missouri
city: Omaha
country: United States
facility: Methodist Cancer Center
state: Nebraska
Study officials:
affiliation: Hoosier Oncology Group, LLC
name: David Potter, M.D.
role: STUDY_CHAIR
References: