Status:
COMPLETED
A Study of a New Combination and Schedule of Chemotherapy Drugs for the Treatment of Head and Neck Cancer
Lead Sponsor:
University of Michigan Rogel Cancer Center
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine the effectiveness and side effects of a new combination and schedule of chemotherapy drugs in the treatment of head and neck cancer. Patients with advanced or...
Detailed Description
Approximately 28,900 patients will be diagnosed with squamous cell cancers of the oral cavity and pharynx in the year 2002. Of these, an estimated 7,400 patients will present with metastases or develo...
Eligibility Criteria
Inclusion
- Patients must have documented advanced, locally recurrent, or metastatic head and neck carcinoma, which is untreatable by surgical resection or radiation therapy.
- Prior chemotherapy for advanced/metastatic disease is allowed (1 regimen only).
- Patients must be taxane-naïve (no prior docetaxel or paclitaxel).
- Patients who have received chemoradiation as a primary therapy for advanced head and neck cancer are eligible.
- Patients must have measurable or evaluable disease. Pre-study imaging for disease assessment must be done within 28 days of registration.
- Patients with brain metastases are eligible if they have been stable for at least six weeks post-radiation therapy.
- Aged 18 years or older
- Performance status of 0-2 by Zubrod criteria.
- Life expectancy of at least 12 weeks.
- Hematologic: absolute neutrophil count (ANC) equal to or \> 1,500/mm3; hemoglobin equal to or \> 8.0 g/dl; platelets equal to or \> 100,000/mm3.
- Total bilirubin must be within normal institutional limits (WNL).
- Transaminases (AST/SGOT and ALT/SGPT) may be up to 2.5 X the institutional upper limit of normal (ULN) if alkaline phosphatase is less than ULN, or alkaline phosphatase may be up to 4 X ULN if transaminases are less than ULN.
- A calculated creatinine clearance of \> 50 ml/min
- Women of childbearing potential must have a negative pregnancy test at baseline, prior to receiving any study drug. (Pregnant or lactating patients are excluded.)
- Patients of reproductive potential must practice effective contraception while on study and for at least six months after receiving the last dose of study drug.
- All patients must sign an informed consent prior to enrollment.
- No prior history of malignancy, except for adequately treated skin cancer or in situ cervical carcinoma or any other cancer in complete remission for at least two years.
Exclusion
- Patients with congestive heart failure, second or third degree heart block or recent myocardial infarction within 12 months from registration are not eligible.
- Peripheral neuropathy equal to or greater than grade 2.
- Patients with a history of severe hypersensitivity reaction to drugs formulated with polysorbate 80.
- Use of standard chemotherapy or investigational agents for treatment of head and neck cancer within 28 days of 1st dose of study drug.
- Any medical or psychiatric illness which, in the opinion of the principal investigator, would compromise the patient's ability to tolerate this treatment regimen.
- Prior unanticipated severe reaction to fluoropyrimidine therapy or known hypersensitivity to 5-fluorouracil.
- Pregnant or lactating women, women of childbearing potential with either a positive pregnancy test (PPT) at baseline, or sexually active females not using a reliable contraceptive method while on study and for at least six months after chemotherapy. (Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential.)
- Sexually active patients not using a reliable contraceptive method while on study and for at least six months after chemotherapy.
- Patients with malabsorption syndromes will be excluded. Administration of capecitabine through feeding tubes is permitted.
- Serious concurrent infections.
- Any other serious uncontrolled medical or surgical conditions that the investigator feels might compromise study participation.
Key Trial Info
Start Date :
November 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00148122
Start Date
November 1 2002
End Date
July 1 2010
Last Update
April 17 2014
Active Locations (1)
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1
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109