TAS-102 and Irinotecan in 2L+ Gastric and Gastroesophageal Adenocarcinoma

Inclusion Criteria

• •Patients must have histologically or cytologically confirmed gastric or gastroesophageal adenocarcinoma
• •Must have locally advanced, recurrent, or metastatic disease not amenable to curative intent surgery.
• •Must have progressed, or not tolerated, at least one line of treatment with a platinum and/or fluoropyrimidine containing regimen. At least one cycle of combination chemotherapy including a platinum (oxaliplatin, cisplatin, carboplatin) and/or fluoropyrimidine (capecitabine or 5-Fluorouracil) based regimen for advanced disease. Combination regimens with platinum/fluoropyrimidine containing a taxane and or a checkpoint inhibitor are allowed. Patients progressing within six months of perioperative chemotherapy or definitive chemoradiation for localized disease are eligible. Patients who have exhausted all other standard of care options are also eligible.
• •Age ≥ 18 years
• •Performance status: ECOG performance status ≤2
• •Life expectancy of greater than 3 months
• •Adequate organ and marrow function as defined below:
• •1. leukocytes : ≥ 3,000/mcL
• •2. absolute neutrophil count: ≥ 1,500/mcL
• •3. platelets: ≥ 80,000/mcl
• •4. total bilirubin: within normal institutional limits
• •5. AST(SGOT)/ALT(SPGT): ≤ 3 X institutional upper limit of normal or ≤ 5 X if liver metastases are present
• •6. creatinine: \< 1.5 X upper limit of normal
• •The effects of TAS-102 on the developing human fetus at the recommended therapeutic dose are unknown. For this reason and because topoisomerase inhibitors are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
• •1\. A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
• •1. Has not undergone a hysterectomy or bilateral oophorectomy; or
• •2. Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
• •Ability to swallow tablets
• •Ability to understand and the willingness to sign a written informed consent.