Academic and Community Cancer Research United
This phase II trial studies the effect of the combination of ramucirumab and trifluridine/tipiracil or paclitaxel in treating patients with previously treated gastric or gastroesophageal junction cancer that has spread to other places in the body (advanced). Ramucirumab may damage tumor cells by targeting new blood vessel formation. Trifluridine/tipiracil is a chemotherapy pill and that may damage tumor cells by damaging their deoxyribonucleic acid (DNA). Paclitaxel may block cell growth by stopping cell division which may kill tumor cells. Giving ramucirumab and trifluridine/tipiracil will not be worse than ramucirumab and paclitaxel in treating gastric or gastroesophageal junction cancer.
PRIMARY OBJECTIVE: I. To compare, in a non-inferiority fashion, the progression-free survival (PFS) in patients with metastatic refractory gastric/gastroesophageal junction (GEJ) adenocarcinoma receiving the combination of ramucirumab with trifluridine and tipiracil hydrochloride (TAS-102) versus (vs.) paclitaxel and ramucirumab. SECONDARY OBJECTIVES: I. To assess overall survival (OS) in this patient population for each regimen. II. Assess changes in patient quality of life (QOL) as measured by the linear analogue self-assessment (LASA) questionnaire for each regimen. III. To determine th…
Inclusion Criteria: * Age \>= 18 years * Histological or cytological confirmation of adenocarcinoma of the stomach or gastroesophageal junction * Have locally advanced unresectable or metastatic disease that has progressed =\< 180 days since last treatment * One or more measurable or nonmeasurable evaluable lesions per Response Evaluation Criteria in Solid Tumors (RECIST) * Planned for second line treatment defined by failing or were intolerant to previous standard chemotherapies containing one or more of the following agents: * Fluoropyrimidine (IV 5-FU or capecitabine) and platinum (cisp…
Given IV
Complete questionnaires
Given IV
Given PO