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Spots Global Cancer Trial Database for Combination Chemotherapy in Treating Patients With Unresectable or Metastatic Biliary Tract or Gallbladder Cancer

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Combination Chemotherapy in Treating Patients With Unresectable or Metastatic Biliary Tract or Gallbladder Cancer

Official Title: Phase II Trial Of Gemcitabine, 5-Fluorouracil, And Leucovorin In Patients With Measurable Unresectable Or Metastatic Biliary Tract Carcinoma (Intrahepatic, Extrahepatic, Ampulla Of Vater) And Gallbladder Carcinoma

Study ID: NCT00009893

Study Description

Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have unresectable or metastatic biliary tract or gallbladder cancer.

Detailed Description: OBJECTIVES: I. Determine the 6-month survival and overall survival of patients with unresectable or metastatic biliary tract carcinoma or gallbladder cancer treated with gemcitabine, fluorouracil, and leucovorin calcium. II. Determine the tumor response in these patients treated with this regimen. III. Determine the toxicity of this regimen in these patients. OUTLINE: Patients receive gemcitabine IV over 30 minutes followed by leucovorin calcium IV and fluorouracil IV over 5-10 minutes on days 1, 8, and 15. Treatment repeats every 4 weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 1 year and then every 6 months for 4 years.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

CCOP - Scottsdale Oncology Program, Scottsdale, Arizona, United States

Mayo Clinic Jacksonville, Jacksonville, Florida, United States

CCOP - Illinois Oncology Research Association, Peoria, Illinois, United States

CCOP - Carle Cancer Center, Urbana, Illinois, United States

CCOP - Cedar Rapids Oncology Project, Cedar Rapids, Iowa, United States

CCOP - Iowa Oncology Research Association, Des Moines, Iowa, United States

Siouxland Hematology-Oncology, Sioux City, Iowa, United States

CCOP - Wichita, Wichita, Kansas, United States

CCOP - Ann Arbor Regional, Ann Arbor, Michigan, United States

CCOP - Duluth, Duluth, Minnesota, United States

Mayo Clinic Cancer Center, Rochester, Minnesota, United States

CentraCare Clinic, Saint Cloud, Minnesota, United States

CCOP - Metro-Minnesota, Saint Louis Park, Minnesota, United States

CCOP - Missouri Valley Cancer Consortium, Omaha, Nebraska, United States

Medcenter One Health System, Bismarck, North Dakota, United States

CCOP - Merit Care Hospital, Fargo, North Dakota, United States

CCOP - Toledo Community Hospital Oncology Program, Toledo, Ohio, United States

Rapid City Regional Hospital, Rapid City, South Dakota, United States

CCOP - Sioux Community Cancer Consortium, Sioux Falls, South Dakota, United States

Contact Details

Name: Steven R. Alberts, MD

Affiliation: Mayo Clinic

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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