RecruitingPhase 2NCT04660760

Ramucirumab and Trifluridine/Tipiracil or Paclitaxel for the Treatment of Patients With Previously Treated Advanced Gastric or Gastroesophageal Junction Cancer

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

Sponsor

Academic and Community Cancer Research United

Enrollment

116 participants

Start Date

Jun 16, 2021

Study Type

INTERVENTIONAL

Conditions

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial tests combinations of chemotherapy drugs — ramucirumab (a drug that blocks tumor blood vessel growth) with either trifluridine/tipiracil or paclitaxel — as second-line treatment for people with advanced stomach or gastroesophageal junction cancer that has progressed after prior chemotherapy. **You may be eligible if...** - You are 18 or older - You have been diagnosed with adenocarcinoma of the stomach or gastroesophageal junction (confirmed by biopsy) - Your cancer has grown or returned within 6 months of your last treatment - You have already received standard first-line chemotherapy (with fluoropyrimidine and platinum, and trastuzumab if HER2-positive) - You are in reasonably good health (ECOG 0–1) - Your blood counts and organ function are within acceptable ranges **You may NOT be eligible if...** - You have not received prior chemotherapy for this cancer - You cannot swallow oral medications - Your blood counts or organ function do not meet the required levels Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPaclitaxel

Given IV

OTHERQuality-of-Life Assessment

Complete questionnaires

BIOLOGICALRamucirumab

Given IV

DRUGTrifluridine and Tipiracil Hydrochloride

Given PO

Locations(15)

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

View Full Details on ClinicalTrials.gov

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NCT04660760

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