Spots Global Cancer Trial Database for Chemotherapy Plus Radiation Therapy in Treating Patients With Unresectable, Residual, or Recurrent Colorectal Cancer
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Trial Identification
Brief Title: Chemotherapy Plus Radiation Therapy in Treating Patients With Unresectable, Residual, or Recurrent Colorectal Cancer
Official Title: Phase I Study of Oral Capecitabine (Xeloda) as a Radiation Enhancer in Locally Unresectable, Residual, or Recurrent Colorectal Cancer Localized in the Pelvis
Study ID: NCT00003704
Conditions
Study Description
Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses x-rays to damage tumor cells. Drugs such as capecitabine may make the tumor cells more sensitive to radiation therapy. PURPOSE: Phase I trial to study the effectiveness of capecitabine in combination with radiation therapy in treating patients who have unresectable, residual, or recurrent colorectal cancer located in the pelvis.
Detailed Description: OBJECTIVES: I. Determine the maximum tolerated dose of oral capecitabine administered in combination with pelvic radiotherapy in patients with unresectable, residual, or locally recurrent cancer localized in the pelvis. II. Determine the tolerance of this regimen in these patients. III. Determine the preliminary evidence of therapeutic acticivity of this regimen in these patients. OUTLINE: This is a dose-escalation study of capecitabine. Patients receive oral capecitabine twice a day 7 days a week for 6 weeks with concurrent radiotherapy. Radiotherapy is initiated on the same day as the initiation of capecitabine and is administered 5 days a week for 5.5-6 weeks. Cohorts of 3-6 patients receive escalating doses of capecitabine until the maximum tolerated dose (MTD) is reached. The MTD is defined as the dose at which 2 of 3 or 6 patients experience dose-limiting toxicity. Patients are followed every 3 months for 2 years and then every 6 months for 1 year. PROJECTED ACCRUAL: A maximum of 51 patients will be accrued for this study.
Keywords
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 - 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 - 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
Altru Health Systems, Grand Forks, North Dakota, 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
Allan Blair Cancer Centre, Regina, Saskatchewan, Canada
Contact Details
Name: Charles Erlichman, MD
Affiliation: Mayo Clinic
Role: STUDY_CHAIR
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