A Phase II Study Of Docetaxel And Capecitabine In Patients With Measurable Metastatic Adenocarcinoma Of The Stomach And Gastroesophageal Junction
OBJECTIVES:
- Determine the objective tumor response rate in patients with metastatic gastric or
gastroesophageal junction adenocarcinoma treated with docetaxel and capecitabine.
- Determine the time to progression in patients treated with this regimen.
- Determine the overall survival in patients treated with this regimen.
- Determine the toxic effects of this regimen in these patients.
- Determine whether interleukin-1 polymorphisms are present among patients who have
weight loss vs no weight loss, and their relationship to a poor prognosis.
- Assess the quality of life and swallowing uniscale during chemotherapy in these
patients.
OUTLINE: Patients receive docetaxel IV over 1 hour on day 1 and oral capecitabine twice
daily on days 1-14. Courses repeat every 21 days for up to 2 years in the absence of disease
progression or unacceptable toxicity.
Quality of life is assessed at baseline, at each tumor measurement, and at the end of
treatment.
Patients are followed every 3 months until disease progression and then every 6 months until
3 years from registration.
PROJECTED ACCRUAL: A total of 15-43 patients will be accrued for this study within 24
months.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Proportion of successes
No
Aminah Jatoi, MD
Study Chair
Mayo Clinic
United States: Federal Government
CDR0000270681
NCT00054457
September 2003
Name | Location |
---|---|
CCOP - Wichita | Wichita, Kansas 67214-3882 |
CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
Fairview Ridges Hospital | Burnsville, Minnesota 55337 |
Mercy and Unity Cancer Center at Mercy Hospital | Coon Rapids, Minnesota 55433 |
Fairview Southdale Hospital | Edina, Minnesota 55435 |
Mercy and Unity Cancer Center at Unity Hospital | Fridley, Minnesota 55432 |
Minnesota Oncology Hematology, PA - Maplewood | Maplewood, Minnesota 55109 |
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital | Minneapolis, Minnesota 55407 |
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center | Robbinsdale, Minnesota 55422-2900 |
Park Nicollet Cancer Center | St. Louis Park, Minnesota 55416 |
United Hospital | St. Paul, Minnesota 55102 |
Ridgeview Medical Center | Waconia, Minnesota 55387 |
Minnesota Oncology Hematology, PA - Woodbury | Woodbury, Minnesota 55125 |
Via Christi Cancer Center at Via Christi Regional Medical Center | Wichita, Kansas 67214 |
Southwest Medical Center | Liberal, Kansas 67901 |
Cancer Center of Kansas, PA - Dodge City | Dodge City, Kansas 67801 |
Cancer Center of Kansas, PA - Chanute | Chanute, Kansas 66720 |
Cancer Center of Kansas, PA - El Dorado | El Dorado, Kansas 67042 |
Cancer Center of Kansas, PA - Kingman | Kingman, Kansas 67068 |
Cancer Center of Kansas, PA - Newton | Newton, Kansas 67114 |
Cancer Center of Kansas, PA - Parsons | Parsons, Kansas 67357 |
Cancer Center of Kansas, PA - Pratt | Pratt, Kansas 67124 |
Cancer Center of Kansas, PA - Salina | Salina, Kansas 67401 |
Cancer Center of Kansas, PA - Wellington | Wellington, Kansas 67152 |
Cancer Center of Kansas, PA - Wichita | Wichita, Kansas 67214 |
Associates in Womens Health, PA - North Review | Wichita, Kansas 67208 |
Cancer Center of Kansas, PA - Medical Arts Tower | Wichita, Kansas 67208 |
Cancer Center of Kansas, PA - Winfield | Winfield, Kansas 67156 |