Gemcitabine and Docetaxel in Treating Patients With Persistent, Recurrent, or Metastatic Head and… (NCT00248560) | Clinical Trial Compass
CompletedPhase 2
Gemcitabine and Docetaxel in Treating Patients With Persistent, Recurrent, or Metastatic Head and Neck Cancer
United States36 participantsStarted 2005-01
Plain-language summary
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.
Who can participate
Age range18 Years – 120 Years
SexALL
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DISEASE CHARACTERISTICS:
* Histologically confirmed squamous cell carcinoma of the head and neck
* Metastatic, persistent, or recurrent disease
* Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
* Must have had definitive surgery and/or radiation therapy AND received at least 1, but no more than 2, chemotherapy regimens, either given as primary therapy or adjuvant therapy before or after surgery and/or radiotherapy
* No active or prior CNS metastasis
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* SWOG 0-2
Life expectancy
* At least 12 weeks
Hematopoietic
* Granulocyte count \> 1,500/mm\^3
* Hemoglobin ≥ 8 g/dL
* Platelet count \> 100,000/mm\^3
Hepatic
* Bilirubin normal
* Meets 1 of the following criteria:
* Alkaline phosphatase (AP) normal AND AST or ALT ≤ 5 times upper limit of normal (ULN)
* AP ≤ 2.5 times ULN AND AST or ALT ≤ 1.5 times ULN
* AP ≤ 5 times ULN AND AST or ALT normal
Renal
* Creatinine \< 1.5 mg/dL
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for ≥ 3 months after completion of study treatment
* No peripheral neuropathy ≥ grade 2
* No active infection requiring systemic therapy
* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix or any other site
* No history of severe …