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

Hoosier Cancer Research Network

Status and phase

Terminated

Phase 2

Conditions

Head and Neck Cancer

Treatments

Drug: Capecitabine

Drug: Premedication

Drug: Docetaxel

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00216138

HOG HN02-40

Details and patient eligibility

About

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.

Full 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

Enrollment

19 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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