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Spots Global Cancer Trial Database for Irinotecan in Treating Patients With Advanced Gallbladder or Bile Duct 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: Irinotecan in Treating Patients With Advanced Gallbladder or Bile Duct Cancer

Official Title: A Phase II Study of CPT-11 in Patients With Advanced Gallbladder or Bile Duct Tumors

Study ID: NCT00003276

Study Description

Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of irinotecan in treating patients with advanced gallbladder or bile duct cancer that cannot be removed surgically.

Detailed Description: OBJECTIVES: I. Evaluate the objective tumor response rate in patients with advanced gallbladder or bile duct tumors treated with irinotecan. II. Evaluate time-to-progression, survival, and toxic effects associated with irinotecan given weekly for 4 weeks every 6 weeks in this patient population. OUTLINE: Patients receive a 90 minute continuous infusion of irinotecan on days 1, 8, 15, and 22 for 4 weeks, followed by a 2 week rest period. Courses of treatment are repeated every 42 days. Patients continue treatment in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 1 year, then every 6 months for the next 4 years. PROJECTED ACCRUAL: Approximately 22-40 patients will be accrued for this study over 2-4 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

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 - Ochsner, New Orleans, Louisiana, United States

CCOP - Ann Arbor Regional, Ann Arbor, Michigan, 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

Quain & Ramstad Clinic, P.C., Bismarck, North Dakota, United States

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

Altru Health Systems, Grand Forks, North Dakota, United States

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

CCOP - Geisinger Clinic and Medical Center, Danville, Pennsylvania, United States

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

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

Saskatchewan Cancer Agency, Regina, Saskatchewan, Canada

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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