A Phase II Study of Patients With Unresectable Metastatic Adenocarcinoma of the Colon or Rectum (Per 04/99 Amendment) Old Title: A Phase II Study of Patients With Unresectable Metastatic Adenocarcinoma of the Colon or Rectum Confined to the Liver
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.
PROJECTED ACCRUAL: A maximum of 44 patients will be accrued for this study over
approximately 2-3 years.
Interventional
Primary Purpose: Treatment
Steven R. Alberts, MD
Study Chair
Mayo Clinic
United States: Federal Government
CDR0000066991
NCT00003834
March 1999
Name | Location |
---|---|
Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
CCOP - Ann Arbor Regional | Ann Arbor, Michigan 48106 |
CCOP - Wichita | Wichita, Kansas 67214-3882 |
CCOP - Missouri Valley Cancer Consortium | Omaha, Nebraska 68131 |
CCOP - Illinois Oncology Research Association | Peoria, Illinois 61602 |
CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
CCOP - Iowa Oncology Research Association | Des Moines, Iowa 50309-1016 |
CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
CCOP - Duluth | Duluth, Minnesota 55805 |
CCOP - Scottsdale Oncology Program | Scottsdale, Arizona 85259-5404 |
CCOP - Cedar Rapids Oncology Project | Cedar Rapids, Iowa 52403-1206 |
Siouxland Hematology-Oncology | Sioux City, Iowa 51101-1733 |
CCOP - Ochsner | New Orleans, Louisiana 70121 |
CentraCare Clinic | Saint Cloud, Minnesota 56303 |
CCOP - Merit Care Hospital | Fargo, North Dakota 58122 |
Altru Health Systems | Grand Forks, North Dakota 58201 |
CCOP - Toledo Community Hospital Oncology Program | Toledo, Ohio 43623-3456 |
CCOP - Sioux Community Cancer Consortium | Sioux Falls, South Dakota 57105-1080 |
CCOP - Geisinger Clinic and Medical Center | Danville, Pennsylvania 17822-2001 |
Medcenter One Health System | Bismarck, North Dakota 58501 |