Trials / Recruiting

RecruitingNCT04660760

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

Status: Recruiting
Phase: Phase 2
Study type: Interventional
Enrollment: 116 (estimated)

Sponsor: Academic and Community Cancer Research United · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

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.

Conditions

Interventions

Type	Name	Description
DRUG	Paclitaxel	Given IV
OTHER	Quality-of-Life Assessment	Complete questionnaires
BIOLOGICAL	Ramucirumab	Given IV
DRUG	Trifluridine and Tipiracil Hydrochloride	Given PO

Timeline

Start date: 2021-06-16
Primary completion: 2024-07-31
Completion: 2026-05-31
First posted: 2020-12-09
Last updated: 2024-04-01

Locations

15 sites across 1 country: United States

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT04660760. Inclusion in this directory is not an endorsement.