Gemcitabine and Doxorubicin in Treating Patients With Recurrent or Progressive Head and Neck Cancer
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|ClinicalTrials.gov Identifier: NCT00509665|
Recruitment Status : Completed
First Posted : July 31, 2007
Results First Posted : July 12, 2018
Last Update Posted : July 12, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer||Drug: doxorubicin hydrochloride Drug: gemcitabine hydrochloride||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Gemcitabine in Combination With Doxorubicin for Patients With Head and Neck Cancer|
|Study Start Date :||June 2005|
|Actual Primary Completion Date :||May 2011|
|Actual Study Completion Date :||May 2011|
Drug: doxorubicin hydrochloride
given as 25mgm2 IV on days 1 and 8 of each 21-day cycle.
Drug: gemcitabine hydrochloride
given as 100mg/m2 IV over days 1 and 8 of each 21 day cycle
- Response Rate [ Time Frame: Every 6 weeks from the time of initial treatment for up to 8 months ]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.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00509665
|United States, South Carolina|
|Hollings Cancer Center at Medical University of South Carolina|
|Charleston, South Carolina, United States, 29425|
|Principal Investigator:||Paul O'Brien||Medical University of South Carolina|