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

Head and Neck Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00216138
• Other study ID #: HOG HN02-40
• Status: Terminated
• Phase: Phase 2
• First received: September 12, 2005
• Last updated: April 28, 2011
• Start date: March 2004
• Est. completion date: September 2007

Study information

• Verified date: April 2011
• Source: Hoosier Cancer Research Network
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: September 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Drug:
• Docetaxel
Docetaxel 60 mg/m2 for 60 minutes, day 1 of each cycle
• Capecitabine
Capecitabine 825 mg/m2 po bid, days 1-14
• Premedication
Dexamethasone and antiemetic premedication

Locations

Country	Name	City	State
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	University of Chicago	Chicago	Illinois
United States	Elkhart Clinic	Elkhart	Indiana
United States	Oncology Hematology Associates of SW Indiana	Evansville	Indiana
United States	Fort Wayne Oncology & Hematology, Inc	Fort Wayne	Indiana
United States	Center for Cancer Care at Goshen Health System	Goshen	Indiana
United States	Indiana University Cancer Center	Indianapolis	Indiana
United States	Quality Cancer Center (MCGOP)	Indianapolis	Indiana
United States	Center for Hematology-Oncology of S Michigan	Jackson	Michigan
United States	Arnett Cancer Care	Lafayette	Indiana
United States	Medical Consultants, P.C.	Muncie	Indiana
United States	Center for Cancer Care, Inc., P.C.	New Albany	Indiana
United States	Helen F. Graham Cancer Center	Newark	Delaware
United States	Methodist Cancer Center	Omaha	Nebraska
United States	Northern Indiana Cancer Research Consortium	South Bend	Indiana
United States	Siteman Cancer Center	St. Louis	Missouri
United States	AP&S Clinic	Terre Haute	Indiana
United States	Providence Medical Group	Terre Haute	Indiana

Sponsors (4)

Lead Sponsor	Collaborator
Hoosier Cancer Research Network	Hoffmann-La Roche, Sanofi, Walther Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	- To assess response rate in a group of patients receiving combination therapy with docetaxel and capecitabine		24 months	No
Secondary	To assess toxicity of the combination		24 months	Yes
Secondary	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	No
Secondary	Efficacy and safety analyses on special sub-cohorts		24 months	Yes
Secondary	To determine the progression free survival and overall survival		24 months	No
Secondary	To assess change in analgesic usage with this protocol therapy		24 months	No

External Links

•   Hoosier Oncology Group Home Page