Spots Global Cancer Trial Database for Ramucirumab and Trifluridine/Tipiracil or Paclitaxel for the Treatment of Patients With Previously Treated Advanced Gastric or Gastroesophageal Junction Cancer
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Trial Identification
Brief Title: Ramucirumab and Trifluridine/Tipiracil or Paclitaxel for the Treatment of Patients With Previously Treated Advanced Gastric or Gastroesophageal Junction Cancer
Official Title: Ramucirumab Plus Trifluridine/Tipiracil (TAS-102) for Patients With Previously Treated Advanced Gastric or Gastroesophageal Junction Adenocarcinoma: An Investigator-Initiated, Randomized Non-Inferiority Phase 2 Study
Study ID: NCT04660760
Conditions
Study Description
Brief Summary: 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.
Detailed Description: 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 the safety of the combination of ramucirumab with TAS-102 in this patient population. OUTLINE: Patients are randomized to 1 of 2 arms. ARM A: Patients receive TAS-102 orally (PO) twice daily (BID) on days 1-5 and 8-12, and ramucirumab intravenously (IV) over 30-60 minutes on days 1 and 15. Treatment repeats every 28 days for up to 36 cycles in the absence of disease progression or unacceptable toxicity. ARM B: Patients receive paclitaxel IV over 1-96 hours on days 1, 8, and 15, and ramucirumab IV over 30-60 minutes on days 1 and 15. Treatment repeats every 28 days for up to 36 cycles in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30-35 days, then every 3 months for up to 3 years.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Alabama at Birmingham Cancer Center, Birmingham, Alabama, United States
Mayo Clinic in Arizona, Scottsdale, Arizona, United States
Arizona Clinical Research Center, Tucson, Arizona, United States
USC / Norris Comprehensive Cancer Center, Los Angeles, California, United States
Mayo Clinic in Florida, Jacksonville, Florida, United States
Cleveland Clinic-Weston, Weston, Florida, United States
Emory University Hospital/Winship Cancer Institute, Atlanta, Georgia, United States
Carle Cancer Center NCI Community Oncology Research Program, Urbana, Illinois, United States
University of Iowa/Holden Comprehensive Cancer Center, Iowa City, Iowa, United States
Cancer Center of Kansas - Wichita, Wichita, Kansas, United States
Metro Minnesota Community Oncology Research Consortium, Saint Louis Park, Minnesota, United States
University of Nebraska Medical Center, Omaha, Nebraska, United States
Vanderbilt University/Ingram Cancer Center, Nashville, Tennessee, United States
Saint Vincent Hospital Cancer Center Green Bay, Green Bay, Wisconsin, United States
Aurora Cancer Care-Milwaukee West, Wauwatosa, Wisconsin, United States
Contact Details
Name: Mohamad B Sonbol
Affiliation: Academic and Community Cancer Research United
Role: PRINCIPAL_INVESTIGATOR
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