Expired Study
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Denver, Colorado 80218


Purpose:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of irinotecan and docetaxel in treating patients who have metastatic or locally recurrent head and neck cancer.


Study summary:

OBJECTIVES: - Determine the response rate in patients with metastatic or locally recurrent head and neck cancer treated with irinotecan and docetaxel. - Determine the progression-free and overall survival of patients treated with this regimen. - Determine the toxic effects of this regimen in these patients. - Correlate angiogenesis markers and cyclooxygenase-2 expression with response and survival in patients treated with this regimen. - Correlate UGT1A1 genotype with the toxic effects of this regimen in these patients. OUTLINE: This is a multicenter study. Patients are stratified according to prior chemotherapy (no prior chemotherapy for locally recurrent or metastatic disease or more than 6 months since prior chemotherapy as primary therapy vs 1 prior chemotherapy regimen for locally recurrent or metastatic disease or less than 6 months since prior chemotherapy as primary therapy). Patients receive docetaxel IV over 60 minutes followed by irinotecan IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 32-72 patients (16-36 per stratum) will be accrued for this study within 6-14 months.


Criteria:

DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed carcinoma of the head and neck - Squamous cell carcinoma - No WHO grade II or III nasopharyngeal carcinoma (well-differentiated nasopharyngeal carcinoma allowed) - Metastatic or locally recurrent disease considered to be incurable by locoregional therapy - Unidimensionally measurable disease outside previously irradiated field unless documented progressive disease or histologically confirmed residual carcinoma at least 8 weeks after completion of radiotherapy PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-1 Life expectancy: - Not specified Hematopoietic: - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin normal - AST and ALT less than 2.5 times upper limit of normal (ULN) and alkaline phosphatase normal OR - Alkaline phosphatase less than 4 times ULN and AST and ALT normal Renal: - Creatinine less than 2.0 mg/dL Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 3 months after study participation - No active infection - No pre-existing grade 2 or greater peripheral neuropathy - No other concurrent medical condition that would preclude study participation - No hypersensitivity to drugs formulated with Polysorbate 80 - No other malignancy within the past 3 years except curatively treated squamous cell or basal cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 2 weeks since prior biologic therapy - Any number of prior biologic therapies (e.g., chimeric antibodies or kinase inhibitors) allowed - No concurrent filgrastim (G-CSF) Chemotherapy: - At least 4 weeks since prior chemotherapy - No prior docetaxel or irinotecan - No more than 1 prior chemotherapy regimen for recurrent or metastatic disease Endocrine therapy: - Not specified Radiotherapy: - See Disease Characteristics - At least 3 weeks since prior radiotherapy for recurrent or metastatic disease and recovered Surgery: - Recovered from prior surgery Other: - No concurrent antiepileptics - No concurrent cyclosporine


NCT ID:

NCT00040807


Primary Contact:

Study Chair
Athanassios Argiris, MD
Robert H. Lurie Cancer Center


Backup Contact:

N/A


Location Contact:

Denver, Colorado 80218
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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