A Phase I Study of TAS-102 plus CPT-11 (Irinotecan) in Patients with Advanced Digestive Cancers

Full Title

A Phase 1, Open-Label, Non-Randomized, Dose-Escalating Safety, Tolerability and Pharmacokinetic Study of TAS-102 in Combination with CPT-11 in Patients with Advanced Gastrointestinal Tumors


TAS-102 is an anticancer drug that works by blocking the formation of new cancer cells. In this study, researchers want to find the highest dose of TAS-102 that can be given safely with CPT-11 (irinotecan), an anticancer drug commonly used to treat colon cancer, in patients with advanced digestive cancers that are not responding to or continue to grow despite standard cancer treatments.

TAS-102 is taken orally (by mouth), and CPT-11 is given intravenously (by vein).


To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have an advanced digestive cancer that has continued to grow despite treatment, including at least one regimen of therapy for advanced cancer.
  • Patients who previously received CPT-11 may participate as long as they can still tolerate this drug.
  • At least 3 weeks must have passed since completion of prior chemotherapy and 4 weeks since radiation therapy or major surgery and entry into the study.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is open to patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Leonard Saltz at 646-888-4181.