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

Who is this study for? Patients with previously treated advanced gastric or gastroesophageal junction adenocarcinoma
What treatments are being studied? Ramucirumab+Trifluridine+Tipiracil Hydrochloride
Status: Recruiting
Location: See all (15) locations...
Intervention Type: Other, Drug, Biological
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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 (cisplatin or oxaliplatin)

⁃ Trastuzumab in case of HER2-positive disease

⁃ NOTE: For the patients whose disease recurred =\< 168 days from the last dose of adjuvant anticancer chemotherapy, that adjuvant anticancer chemotherapy is counted as 1 prior chemotherapy line

• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1

• Ability to swallow oral medications

• Absolute neutrophil count (ANC) \>= 1500/mm\^3 (obtained =\< 7 days prior to registration)

• Platelet count \>= 100,000/mm\^3 (obtained =\< 7 days prior to registration)

• Hemoglobin \>= 9.0 g/dL (obtained =\< 7 days prior to registration)

• Total bilirubin =\< 1.5 x upper limit of normal (ULN) (obtained =\< 7 days prior to registration)

• Aspartate transaminase (AST) and alanine transaminase (ALT) =\< 3 x ULN ( =\< 5.0 x UNL, if with liver metastasis) (obtained =\< 7 days prior to registration)

• International normalized ratio (INR) =\< 1.5 x ULN, and a partial thromboplastin time (PTT) =\< 5 seconds above the ULN (unless receiving anticoagulation therapy) (obtained =\< 7 days prior to registration)

‣ Note: Patients receiving warfarin must be switched to low molecular weight heparin and have achieved stable coagulation profile prior to first dose of protocol therapy

⁃ Note: Patients on full-dose anticoagulation must be on a stable dose (minimum duration 14 days) of oral anticoagulant or low molecular weight heparin (LMWH)

⁃ Exception: If receiving warfarin, the patient must have an INR =\< 3.0. For heparin and LMWH there should be no active bleeding (that is, no bleeding within 14 days prior to first dose of protocol therapy) or pathological condition present that carries a high risk of bleeding (for example, tumor involving major vessels or known varices)

• Urinary protein is =\< 1+ on dipstick or routine urinalysis (UA; if urine dipstick or routine analysis is \>= 2+, a 24-hour urine collection for protein must demonstrate =\< 1000 mg of protein in 24 hours to allow participation in this protocol) (obtained =\< 7 days prior to registration)

• Creatinine =\< 1.5 times the ULN or creatinine clearance (measured via 24-hour urine collection) \>= 50 mL/minute (that is, if serum creatinine is \>= 1.5 times the ULN, a 24-hour urine collection to calculate creatinine clearance must be performed) (obtained =\< 7 days prior to registration)

• Negative pregnancy test done =\< 7 days prior to registration, for women of childbearing potential only

• Ability to complete questionnaire(s) by themselves or with assistance

• Provide informed written consent =\< 28 days prior to registration

• Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study)

• Because the teratogenicity of ramucirumab is not known, the patient, if sexually active, must be postmenopausal, surgically sterile, or using effective contraception (hormonal or barrier methods)

Locations
United States
Alabama
University of Alabama at Birmingham Cancer Center
NOT_YET_RECRUITING
Birmingham
Arizona
Mayo Clinic in Arizona
RECRUITING
Scottsdale
Arizona Clinical Research Center
WITHDRAWN
Tucson
California
USC / Norris Comprehensive Cancer Center
RECRUITING
Los Angeles
Florida
Mayo Clinic in Florida
RECRUITING
Jacksonville
Cleveland Clinic-Weston
RECRUITING
Weston
Georgia
Emory University Hospital/Winship Cancer Institute
WITHDRAWN
Atlanta
Iowa
University of Iowa/Holden Comprehensive Cancer Center
NOT_YET_RECRUITING
Iowa City
Illinois
Carle Cancer Center NCI Community Oncology Research Program
WITHDRAWN
Urbana
Kansas
Cancer Center of Kansas - Wichita
WITHDRAWN
Wichita
Minnesota
Metro Minnesota Community Oncology Research Consortium
COMPLETED
Saint Louis Park
Nebraska
University of Nebraska Medical Center
WITHDRAWN
Omaha
Tennessee
Vanderbilt University/Ingram Cancer Center
RECRUITING
Nashville
Wisconsin
Saint Vincent Hospital Cancer Center Green Bay
RECRUITING
Green Bay
Aurora Cancer Care-Milwaukee West
WITHDRAWN
Wauwatosa
Time Frame
Start Date: 2021-06-16
Estimated Completion Date: 2026-05-31
Participants
Target number of participants: 116
Treatments
Experimental: Arm A (TAS-102, ramucirumab)
Patients receive TAS-102 PO BID on days 1-5 and 8-12, 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.
Active_comparator: Arm B (paclitaxel, ramucirumab)
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.
Related Therapeutic Areas
Sponsors
Leads: Academic and Community Cancer Research United
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov

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