Combination Chemotherapy in Treating Patients With Liver Metastases From Colorectal Cancer
- Conditions
- Colorectal CancerMetastatic Cancer
- Interventions
- Registration Number
- NCT00003834
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- 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 with liver metastases from colorectal cancer.
- Detailed Description
OBJECTIVES: I. Evaluate the efficacy of treatment with oxaliplatin, fluorouracil, and leucovorin calcium in terms of the resectability rate in patients with unresectable advanced colorectal carcinoma confined to the liver. II. Assess this regimen in terms of response rate, toxicity, and overall survival in these patients.
OUTLINE: Patients receive oxaliplatin IV over 2 hours on day 1, then leucovorin calcium IV over 2 hours with fluorouracil IV bolus, followed by fluorouracil IV over 22 hours on days 1 and 2. Courses repeat every 2 weeks. Patients with stable disease continue treatment in the absence of disease progression or unacceptable toxicity or until disease is resectable. Patients who achieve complete response (CR), partial response (PR) with unresectable disease, or PR but are not surgical candidates continue treatment in the absence of disease progression or unacceptable toxicity. Patients who demonstrate a response are treated until best response or until disease is deemed resectable. Patients who achieve a CR or PR and are resected may receive 2 to 4 additional courses of therapy at the discretion of the investigator. Patients are followed every 3 months for 1 year and then every 6 months for 2 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 44
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description oxaliplatin + leucovorin + fluorouracil leucovorin calcium Patients receive oxaliplatin IV over 2 hours on day 1, then leucovorin calcium IV over 2 hours with fluorouracil IV bolus, followed by fluorouracil IV over 22 hours on days 1 and 2. Courses repeat every 2 weeks. Patients with stable disease continue treatment in the absence of disease progression or unacceptable toxicity or until disease is resectable. Patients who achieve complete response (CR), partial response (PR) with unresectable disease, or PR but are not surgical candidates continue treatment in the absence of disease progression or unacceptable toxicity. Patients who demonstrate a response are treated until best response or until disease is deemed resectable. Patients who achieve a CR or PR and are resected may receive 2 to 4 additional courses of therapy at the discretion of the investigator. Patients are followed every 3 months for 1 year and then every 6 months for 2 years. oxaliplatin + leucovorin + fluorouracil fluorouracil Patients receive oxaliplatin IV over 2 hours on day 1, then leucovorin calcium IV over 2 hours with fluorouracil IV bolus, followed by fluorouracil IV over 22 hours on days 1 and 2. Courses repeat every 2 weeks. Patients with stable disease continue treatment in the absence of disease progression or unacceptable toxicity or until disease is resectable. Patients who achieve complete response (CR), partial response (PR) with unresectable disease, or PR but are not surgical candidates continue treatment in the absence of disease progression or unacceptable toxicity. Patients who demonstrate a response are treated until best response or until disease is deemed resectable. Patients who achieve a CR or PR and are resected may receive 2 to 4 additional courses of therapy at the discretion of the investigator. Patients are followed every 3 months for 1 year and then every 6 months for 2 years. oxaliplatin + leucovorin + fluorouracil oxaliplatin Patients receive oxaliplatin IV over 2 hours on day 1, then leucovorin calcium IV over 2 hours with fluorouracil IV bolus, followed by fluorouracil IV over 22 hours on days 1 and 2. Courses repeat every 2 weeks. Patients with stable disease continue treatment in the absence of disease progression or unacceptable toxicity or until disease is resectable. Patients who achieve complete response (CR), partial response (PR) with unresectable disease, or PR but are not surgical candidates continue treatment in the absence of disease progression or unacceptable toxicity. Patients who demonstrate a response are treated until best response or until disease is deemed resectable. Patients who achieve a CR or PR and are resected may receive 2 to 4 additional courses of therapy at the discretion of the investigator. Patients are followed every 3 months for 1 year and then every 6 months for 2 years.
- Primary Outcome Measures
Name Time Method response rate Up to 4 years
- Secondary Outcome Measures
Name Time Method overall survival Up to 4 years
Trial Locations
- Locations (21)
CCOP - Carle Cancer Center
🇺🇸Urbana, Illinois, United States
CCOP - Duluth
🇺🇸Duluth, Minnesota, United States
CentraCare Clinic
🇺🇸Saint Cloud, Minnesota, United States
CCOP - Metro-Minnesota
🇺🇸Saint Louis Park, Minnesota, United States
Medcenter One Health System
🇺🇸Bismarck, North Dakota, United States
Altru Health Systems
🇺🇸Grand Forks, North Dakota, United States
Allan Blair Cancer Centre
🇨🇦Regina, Saskatchewan, Canada
CCOP - Geisinger Clinic and Medical Center
🇺🇸Danville, Pennsylvania, United States
CCOP - Scottsdale Oncology Program
🇺🇸Scottsdale, Arizona, United States
CCOP - Cedar Rapids Oncology Project
🇺🇸Cedar Rapids, Iowa, United States
CCOP - Ochsner
🇺🇸New Orleans, Louisiana, United States
CCOP - Sioux Community Cancer Consortium
🇺🇸Sioux Falls, South Dakota, United States
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
CCOP - Missouri Valley Cancer Consortium
🇺🇸Omaha, Nebraska, United States
CCOP - Iowa Oncology Research Association
🇺🇸Des Moines, Iowa, United States
CCOP - Illinois Oncology Research Association
🇺🇸Peoria, Illinois, United States
Siouxland Hematology-Oncology
🇺🇸Sioux City, Iowa, United States
CCOP - Merit Care Hospital
🇺🇸Fargo, North Dakota, United States
CCOP - Toledo Community Hospital Oncology Program
🇺🇸Toledo, Ohio, United States
CCOP - Wichita
🇺🇸Wichita, Kansas, United States
CCOP - Ann Arbor Regional
🇺🇸Ann Arbor, Michigan, United States