Irinotecan and Docetaxel in Treating Patients With Metastatic or Locally Recurrent Head and Neck … (NCT00040807) | Clinical Trial Compass
CompletedPhase 2
Irinotecan and Docetaxel in Treating Patients With Metastatic or Locally Recurrent Head and Neck Cancer
United StatesStarted 2002-11-19
Plain-language summary
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.
Who can participate
Age range18 Years – 120 Years
SexALL
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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 ca…