Status:
TERMINATED
Docetaxel and Capecitabine for First Line Treatment of Metastatic Squamous Cell Carcinoma of the Head & Neck
Lead Sponsor:
Hoosier Cancer Research Network
Collaborating Sponsors:
Sanofi
Hoffmann-La Roche
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 recurr...
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 Re...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2007
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00216138
Start Date
March 1 2004
End Date
September 1 2007
Last Update
May 2 2011
Active Locations (18)
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1
Helen F. Graham Cancer Center
Newark, Delaware, United States, 19713
2
University of Chicago
Chicago, Illinois, United States, 60637
3
Elkhart Clinic
Elkhart, Indiana, United States, 46515
4
Oncology Hematology Associates of SW Indiana
Evansville, Indiana, United States, 47714