Phase II Trial Of Weekly Irinotecan And Docetaxel In Recurrent Or Metastatic Head And Neck Carcinoma

Inclusion 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