Capecitabine and Lapatinib Ditosylate in Treating Patients With Squamous Cell Cancer of the Head … (NCT01044433) | Clinical Trial Compass
CompletedPhase 2
Capecitabine and Lapatinib Ditosylate in Treating Patients With Squamous Cell Cancer of the Head and Neck
United States44 participantsStarted 2009-10
Plain-language summary
RATIONALE: Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Lapatinib ditosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving capecitabine together with lapatinib ditosylate may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving capecitabine and lapatinib ditosylate together works in treating patients with squamous cell cancer of the head and neck.
Who can participate
Age range18 Years
SexALL
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Inclusion
* Histologically or cytologically confirmed SCCHN
* All primary sites are eligible excluding nasopharyngeal
* Metastatic disease or locally recurrent disease not felt amenable to curative therapy (as determined by a physician)
* ECOG performance status 0-2
* No prior chemotherapy in the metastatic / locally advanced, recurrent incurable setting; patients may have received prior curative-intention chemotherapy including induction chemotherapy, chemotherapy concurrent with radiation and adjuvant chemotherapy
* No prior capecitabine; patients who have received 5-FU or other fluoropyrimidines in the curative-intention setting will not be excluded, as long as more than 6 mos have elapsed since prior 5-FU exposure
* No previous history of Lapatinib
* Previous use of cetuximab in the curative-intention setting will not result in exclusion, as long as at least four weeks have elapsed since prior C225 exposure
* Patients may have received radiation therapy in the definitive, adjuvant or metastatic setting; radiation therapy must be completed at least 14 days prior to study participation
* ECOG performance status of 0-2 (Karnofsky \>= 60%)
* Must have normal organ and marrow function
* Laboratory tests should be completed within 14 days prior to registration
* Left ventricular ejection fraction (LVEF) can be determined by either echocardiography or nuclear scintigraphy and should be obtained within 21 days of enrollment
* Platelets \>= 100,000/mm\^3
* Total bilirubin =\< 2
*…