Irinotecan and Docetaxel in Treating Patients With Metastatic or Locally Recurrent Head and Neck Cancer
Head and Neck Cancer
About this trial
This is an interventional treatment trial for Head and Neck Cancer focused on measuring recurrent metastatic squamous neck cancer with occult primary, metastatic squamous neck cancer with occult primary squamous cell carcinoma, stage IV squamous cell carcinoma of the lip and oral cavity, recurrent squamous cell carcinoma of the lip and oral cavity, stage IV squamous cell carcinoma of the oropharynx, recurrent squamous cell carcinoma of the oropharynx, stage IV squamous cell carcinoma of the nasopharynx, recurrent squamous cell carcinoma of the nasopharynx, stage IV squamous cell carcinoma of the hypopharynx, recurrent squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the larynx, recurrent squamous cell carcinoma of the larynx, stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity, recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity, recurrent salivary gland cancer, salivary gland squamous cell carcinoma, stage IV salivary gland cancer
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
Sites / Locations
- University of Alabama at Birmingham Comprehensive Cancer Center
- Stanford Cancer Center at Stanford University Medical Center
- Medical Center of Aurora - South Campus
- Boulder Community Hospital
- Penrose Cancer Center
- Porter Adventist Hospital
- St. Joseph Hospital
- Presbyterian - St. Luke's Medical Center
- Rocky Mountain Cancer Centers - Denver Rose
- CCOP - Colorado Cancer Research Program, Incorporated
- Swedish Medical Center
- Sky Ridge Medical Center
- Hope Cancer Care Center at Longmont United Hospital
- St. Mary-Corwin Regional Medical Center
- Rocky Mountain Cancer Centers - Thornton
- CCOP - Christiana Care Health Services
- H. Lee Moffitt Cancer Center and Research Institute
- Veterans Affairs Medical Center - Atlanta (Decatur)
- Veterans Affairs Medical Center - Lakeside Chicago
- Robert H. Lurie Comprehensive Cancer Center at Northwestern University
- CCOP - Evanston
- CCOP - Illinois Oncology Research Association
- CCOP - Carle Cancer Center
- CCOP - Cedar Rapids Oncology Project
- CCOP - Iowa Oncology Research Association
- CCOP - Wichita
- MBCCOP - LSU Health Sciences Center
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Tufts - New England Medical Center
- CCOP - Kalamazoo
- West Michigan Cancer Center
- Mayo Clinic Cancer Center
- CCOP - Southern Nevada Cancer Research Foundation
- CCOP - Northern New Jersey
- Albert Einstein Clinical Cancer Center
- MBCCOP-Our Lady of Mercy Cancer Center
- CCOP - Toledo Community Hospital
- CCOP - Oklahoma
- CCOP - Sioux Community Cancer Consortium
- CCOP - St. Vincent Hospital Cancer Center, Green Bay
- University of Wisconsin Comprehensive Cancer Center
- CCOP - Marshfield Clinic Research Foundation
- Medical College of Wisconsin Cancer Center