Gemcitabine and Docetaxel in Treating Patients With Persistent, Recurrent, or Metastatic Head and Neck Cancer
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.
Head and Neck Cancer
Drug: gemcitabine hydrochloride
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Gemcitabine and Docetaxel (GEMDOC) Combination in Patients With Previously Treated Recurrent or Metatstatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)|
- Response (CR+PR) [ Time Frame: every 2 months ] [ Designated as safety issue: No ]
- Response Duration [ Time Frame: every 2 months ] [ Designated as safety issue: No ]
- Survival [ Time Frame: every 2 months ] [ Designated as safety issue: No ]
- Toxicity as Measured by Number and Grade of Adverse Events [ Time Frame: every 2 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2005|
|Study Completion Date:||June 2012|
|Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
|Experimental: Gemcitabine, docetaxel||Drug: docetaxel Drug: gemcitabine hydrochloride|
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00248560
|United States, Michigan|
|Barbara Ann Karmanos Cancer Institute|
|Detroit, Michigan, United States, 48201-1379|
|Detroit, Michigan, United States, 48235|
|Principal Investigator:||Omer Kucuk, MD||Barbara Ann Karmanos Cancer Institute|