Phase I/II Trial Of Gemcitabine And ALIMTA In Patients With Measurable Or Evaluable, Unresectable Or Metastatic Biliary Tract Carcinoma (Intrahepatic, Extrahepatic, Ampulla Or Vater) And Gallbladder Carcinoma
OBJECTIVES:
- Determine the maximum tolerated dose of gemcitabine when administered with pemetrexed
disodium in patients with unresectable or metastatic biliary tract or gallbladder
cancer. (Phase I closed to accrual as of Oct. 2005.)
- Determine the 6-month survival rate of patients treated with this regimen.
- Determine the best objective tumor response rate and duration of best objective tumor
response in patients treated with this regimen.
- Determine the time to progression and overall survival of patients treated with this
regimen.
- Determine the toxic effects of this regimen in these patients.
- Determine the individual patient variation in toxicity of and/or response to this
regimen due to genetic differences in proteins involved in drug response in these
patients.
OUTLINE: This is a multicenter phase I dose-escalation study of gemcitabine followed by a
phase II study.
- Phase I: Patients receive pemetrexed disodium IV over 10 minutes and gemcitabine IV
over 30 minutes on days 1 and 15. Courses repeat every 28 days in the absence of
disease progression or unacceptable toxicity (phase I closed to accrual as of October
2005).
Cohorts of 3-6 patients receive escalating doses of gemcitabine until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2
of 6 patients experience dose-limiting toxicity.
- Phase II: Patients receive pemetrexed disodium as in phase I and gemcitabine at the
recommended phase II dose.
Patients are followed every 3 months for 1 year and then every 6 months for 4 years.
PROJECTED ACCRUAL: A total of 85 patients will be accrued for this study.
Interventional
Primary Purpose: Treatment
Survival after 6 months of treatment
No
Steven R. Alberts, MD
Study Chair
Mayo Clinic
United States: Federal Government
CDR0000298862
NCT00059865
January 2004
Name | Location |
---|---|
CCOP - Upstate Carolina | Spartanburg, South Carolina 29303 |
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 |
St. Vincent Hospital Regional Cancer Center | Green Bay, Wisconsin 54307-3508 |
Green Bay Oncology, Limited - Escanaba | Escanaba, Michigan 49431 |
Dickinson County Healthcare System | Iron Mountain, Michigan 49801 |
St. Mary's Hospital Medical Center - Green Bay | Green Bay, Wisconsin 54303 |
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center | Green Bay, Wisconsin 54301-3526 |
Green Bay Oncology, Limited at St. Mary's Hospital | Green Bay, Wisconsin 54303 |
Bay Area Cancer Care Center at Bay Area Medical Center | Marinette, Wisconsin 54143 |
Green Bay Oncology, Limited - Oconto Falls | Oconto Falls, Wisconsin 54154 |
Green Bay Oncology, Limited - Sturgeon Bay | Sturgeon Bay, Wisconsin 54235 |
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 |
Rutherford Hospital | Rutherfordton, North Carolina 28139 |
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | Spartanburg, South Carolina 29303 |
AnMed Cancer Center | Anderson, South Carolina 29621 |