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, 35211
Mayo Clinic
Scottsdale, Arizona, 85259
California Cancer Associates for Research and Excellence
Fresno, California, 93720
Global Cancer Research Institute (GCRI), Inc.
Gilroy, California, 95020
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Pacific Hematology Oncology Associates (PHOA)
San Francisco, California, 94115
Rocky Mountain Cancer Center
Denver, Colorado, 80218
Yale Cancer Center
New Haven, Connecticut, 06520
Georgetown Lombardi Comprehensive Cancer Center
Washington, District of Columbia, 20007
University of Florida Health Davis Cancer Center
Gainesville, Florida, 32610
Ocala Oncology Center
Ocala, Florida, 34471
Winship Cancer Institute of Emory University
Atlanta, Georgia, 30322
The University of Chicago
Chicago, Illinois, 60637
Illinois CancerCare, P.C.
Peoria, Illinois, 61615-7828
Massachusetts General Hospital
Boston, Massachusetts, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
University of Michigan Hospital
Ann Arbor, Michigan, 48109
Karmanos Cancer Institute
Detroit, Michigan, 48201
Mayo Clinic
Rochester, Minnesota, 55905
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
University of Rochester
Rochester, New York, 14642
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157
Gabrail Cancer Center Research
Canton, Ohio, 44718
The Mark H. Zangmeister Center
Columbus, Ohio, 43219
Hematology and Oncology Associates of Northeastern Pennsylvania
Dunmore, Pennsylvania, 18512
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232
Texas Oncology Sammons Cancer Center
Dallas, Texas, 75246
Seattle Cancer Care Alliance
Seattle, Washington, 98109
Fox Valley Hematology & Oncology
Appleton, Wisconsin, 54915