RATIONALE: Drugs used in chemotherapy, such as gemcitabine and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving gemcitabine together with docetaxel works in treating patients with persistent, recurrent, or metastatic head and neck cancer.
OBJECTIVES: Primary * Determine the response rate in patients with previously treated persistent, recurrent, or metastatic squamous cell carcinoma of the head and neck treated with gemcitabine and docetaxel. Secondary * Determine the toxicity of this regimen in these patients. * Determine the duration of response and survival of patients treated with this regimen. OUTLINE: Patients receive gemcitabine IV over 30 minutes and docetaxel IV over 60 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. Patients achieving complete response (CR) receive 4 additional courses of therapy beyond documentation of CR. After completion of study treatment, patients are followed for survival. PROJECTED ACCRUAL: A total of 17-41 patients will be accrued within 42-49 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
36
Gemcitabine given 3000 mg/m2 IV over 30 minutes and Docetaxel given 60mg/m2 IV over 60 minutes. The Docetaxel should be administered after the Gemcitabine.
Gemcitabine given 3000 mg/m2 IV over 30 minutes and Docetaxel given 60mg/m2 IV over 60 minutes. The Docetaxel should be administered after the Gemcitabine.
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Response (Complete Response [CR] + Partial Response [PR])
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time frame: every 8 weeks for approximately 8 - 48 weeks
Response Duration
Response duration in months
Time frame: Every 8 weeks
Survival
Overall Survival using the Kaplan-Meier method
Time frame: Every 8 weeks
Toxicity as Measured by Number and Grade of Adverse Events
Toxicity as the total number of participants with a given grade 3 and/or grade 4 adverse event
Time frame: Every 2 weeks
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