Irinotecan and Docetaxel in Treating Patients With Metastatic or Locally Recurrent Head and Neck Cancer

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.

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.

Eligibility 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