RATIONALE: Drugs used in chemotherapy, such as gemcitabine and doxorubicin, 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 doxorubicin works in treating patients with recurrent or progressive head and neck cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
given as 25mgm2 IV on days 1 and 8 of each 21-day cycle.
given as 100mg/m2 IV over days 1 and 8 of each 21 day cycle
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, United States
Response Rate
Per Response Evaluation Criteria in Solid Tumors (RECIST) for target lesions assessed by CT or MRI: Complete Response (CR) is the disappearance of all target lesions (TL) and non-target lesions (NTL); Partial Response (PR) is defined by either a CR of TL and stable disease (SD) in NTL or PR of TL and non-progressive disease (PD) in NTL. Response rate is the sum of CR + PR as defined above.
Time frame: Every 6 weeks from the time of initial treatment for up to 8 months
Duration of Response
Time frame: Every 6 weeks for up to 8 months
Progression-free Survival
Time frame: Through the end of follow up, for an average of 8 months
Overall Survival
Time frame: From the time of initial therapy until the time of death.
Number of Patients Who Had Greater Than Grade 2 Toxicity
Time frame: from time of initial treatment until end of study, an average of 6 months
Correlation of Cytoxocity With Cell-cycle Arrest
Time frame: prior to first dose of drug and every 6 weeks up to 6 months
Correlation of Cytotoxicity With Apoptosis in Cancer Cells
Time frame: prior to first dose of drug and every 6 weeks for up to 6 months
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