The objective of the program is to provide access to TAS-102 to patients with metastatic colorectal cancer who are refractory to or failing standard chemotherapy, are new to therapy with TAS-102 and in whom therapy with TAS-102 is clinically indicated.
This is an open-label study to provide expanded access to TAS-102 prior to its commercial
availability for patients with metastatic colorectal cancer who have been previously treated
with, or are not candidates for fluoropyrimidine-, irinotecan-, and oxaliplatin-based
chemotherapy, an anti-vascular endothelial growth factor (VEGF) therapy, and an
anti-epidermal growth factor receptor (EGFR) therapy.
Serious adverse event information (whether or not related to TAS-102) as well as reports of
pregnancy, overdose, or medication error will reported. In addition, all grades of adverse
drug reactions (ADRs, adverse events related to study medication) and any adverse event that
results in treatment discontinuation will be recorded as study data on CRFs.
Drug: TAS-102
At a dose of 35 mg/m2 administered orally twice daily for 5 days a week with 2 days rest for 14 days, followed by a 14-day rest (1 treatment cycle)
Inclusion Criteria:
1. Has provided written informed consent
2. Has adenocarcinoma of the colon or rectum
3. Has failed at least 2 prior regimens of standard chemotherapies for metastatic
colorectal cancer
4. ECOG performance status of 0 or 1
5. Is able to take medications orally
6. Has adequate organ function (bone marrow, kidney and liver)
7. Women of childbearing potential must have a negative pregnancy test and must agree to
adequate birth control if conception is possible. Males must agree to adequate birth
control.
Exclusion Criteria:
1. Certain serious illnesses or medical condition(s)
2. Has had certain other recent treatment e.g. major surgery, anticancer therapy,
extended field radiation, received investigational agent, within the specified time
frames prior to study drug administration
3. Has received TAS-102
4. Has unresolved toxicity of greater than or equal to CTCAE Grade 2 attributed to any
prior therapies
5. Is a pregnant or lactating female
Alabama Oncology
Birmingham, Alabama, United States
Mayo Clinic
Scottsdale, Arizona, United States
California Cancer Associates for Research and Excellence
Fresno, California, United States
Global Cancer Research Institute (GCRI), Inc.
Gilroy, California, United States
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States
Pacific Hematology Oncology Associates (PHOA)
San Francisco, California, United States
Rocky Mountain Cancer Center
Denver, Colorado, United States
Yale Cancer Center
New Haven, Connecticut, United States
Georgetown Lombardi Comprehensive Cancer Center
Washington, District of Columbia, United States
University of Florida Health Davis Cancer Center
Gainesville, Florida, United States
Ocala Oncology Center
Ocala, Florida, United States
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States
The University of Chicago
Chicago, Illinois, United States
Illinois CancerCare, P.C.
Peoria, Illinois, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
University of Michigan Hospital
Ann Arbor, Michigan, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
University of Rochester
Rochester, New York, United States
Wake Forest Baptist Health
Winston-Salem, North Carolina, United States
Gabrail Cancer Center Research
Canton, Ohio, United States
The Mark H. Zangmeister Center
Columbus, Ohio, United States
Hematology and Oncology Associates of Northeastern Pennsylvania
Dunmore, Pennsylvania, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Texas Oncology Sammons Cancer Center
Dallas, Texas, United States
Seattle Cancer Care Alliance
Seattle, Washington, United States
Fox Valley Hematology & Oncology
Appleton, Wisconsin, United States