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

NCT04660760 | Recruiting Phase 2 FDA Drug

• 3 other identifiers: ACCRU-GI-1810NCI-2020-11436P30CA015083
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 15

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.

Conditions

Clinical Stage III Gastric Cancer AJCC v8; Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8; Clinical Stage IV Gastric Cancer AJCC v8; Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8; Clinical Stage IVA Gastric Cancer AJCC v8; Clinical Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8; Clinical Stage IVB Gastric Cancer AJCC v8; Clinical Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8; Locally Advanced Unresectable Gastric Adenocarcinoma; Locally Advanced Unresectable Gastroesophageal Junction Adenocarcinoma; Metastatic Gastric Adenocarcinoma; Metastatic Gastroesophageal Junction Adenocarcinoma; Pathologic Stage III Gastric Cancer AJCC v8; Pathologic Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8; Pathologic Stage IIIA Gastric Cancer AJCC v8; Pathologic Stage IIIA Gastroesophageal Junction Adenocarcinoma AJCC v8; Pathologic Stage IIIB Gastric Cancer AJCC v8; Pathologic Stage IIIB Gastroesophageal Junction Adenocarcinoma AJCC v8; Pathologic Stage IIIC Gastric Cancer AJCC v8; Pathologic Stage IV Gastric Cancer AJCC v8; Pathologic Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8; Pathologic Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8; Pathologic Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8; Postneoadjuvant Therapy Stage III Gastric Cancer AJCC v8; Postneoadjuvant Therapy Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8; Postneoadjuvant Therapy Stage IIIA Gastroesophageal Junction Adenocarcinoma AJCC v8; Postneoadjuvant Therapy Stage IIIB Gastroesophageal Junction Adenocarcinoma AJCC v8; Postneoadjuvant Therapy Stage IV Gastric Cancer AJCC v8; Postneoadjuvant Therapy Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8; Postneoadjuvant Therapy Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8; Postneoadjuvant Therapy Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  Progression free survival is defined as the time interval between randomization date and the date of disease progression or death (referred to as an "event"), whichever occurs first. Disease progression will be determined based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. The median progression free survival will be estimated using the Kaplan-Meier method for each arm, corresponding 95% confidence intervals, and hazard ratio comparing the treatment arm to the control arm will be reported.

  Up to 1 year

Secondary Outcomes (3)

• Overall survival (OS)

  Up to 3 years

• Quality of life (QOL)

  Up to 3 years

• Incidence of adverse events

  Up to 3 years

Study Arms (2)

Arm A (TAS-102, ramucirumab)

EXPERIMENTAL

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.

Other: Quality-of-Life Assessment; Biological: Ramucirumab; Drug: Trifluridine and Tipiracil Hydrochloride

Arm B (paclitaxel, ramucirumab)

ACTIVE COMPARATOR

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.

Drug: Paclitaxel; Other: Quality-of-Life Assessment; Biological: Ramucirumab

Interventions

Paclitaxel DRUG

Given IV

Also known as: Anzatax, Asotax, Bristaxol, Praxel, Taxol, Taxol Konzentrat

Arm B (paclitaxel, ramucirumab)

Quality-of-Life Assessment OTHER

Complete questionnaires

Also known as: Quality of Life Assessment

Arm A (TAS-102, ramucirumab); Arm B (paclitaxel, ramucirumab)

Ramucirumab BIOLOGICAL

Given IV

Also known as: Anti-VEGFR-2 Fully Human Monoclonal Antibody IMC-1121B, Cyramza, IMC-1121B, LY3009806, Monoclonal Antibody HGS-ETR2

Arm A (TAS-102, ramucirumab); Arm B (paclitaxel, ramucirumab)

Trifluridine and Tipiracil Hydrochloride DRUG

Given PO

Also known as: Lonsurf, TAS 102, TAS-102, Tipiracil Hydrochloride Mixture with Trifluridine, Trifluridine/Tipiracil, Trifluridine/Tipiracil Hydrochloride Combination Agent TAS-102

Arm A (TAS-102, ramucirumab)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown:
• Pregnant women
• Nursing women
• Women of childbearing potential who are unwilling to employ adequate contraception
• Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
• Previous treatment with TAS-102 or ramucirumab
• Previous taxane therapy =\< 180 days prior to registration
• Any grade 3-4 gastrointestinal (GI) bleeding =\< 90 days prior to registration
• History of deep vein thrombosis (DVT), pulmonary embolism (PE), or any other significant thromboembolism (venous port or catheter thrombosis or superficial venous thrombosis are not considered "significant") =\< 90 days prior to registration
• Any arterial thromboembolic events, including but not limited to myocardial infarction, transient ischemic attack, cerebrovascular accident, or unstable angina, =\< 180 days prior to registration
• Prior history of GI perforation/fistula =\< 180 days of registration or risk factors for perforation
• Serious or nonhealing wound, ulcer, or bone fracture =\< 28 days prior to registration
• Major surgery =\< 28 days prior to first dose of protocol therapy, or minor surgery/subcutaneous venous access device placement =\< 7 days prior to registration
• Elective or planned major surgery to be performed during the course of the clinical trial
• Cirrhosis at a level of Child-Pugh B (or worse) or cirrhosis (any degree) and a history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis. NOTE: Clinically meaningful ascites is defined as ascites from cirrhosis requiring diuretics or paracentesis

Sponsors & Collaborators

• Academic and Community Cancer Research United: lead
• National Cancer Institute (NCI): collaborator

Study Sites (15)

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, 35233, United States

NOT YET RECRUITING

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

RECRUITING

Arizona Clinical Research Center

Tucson, Arizona, 85715, United States

WITHDRAWN

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

RECRUITING

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

RECRUITING

Cleveland Clinic-Weston

Weston, Florida, 33331, United States

RECRUITING

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, 30322, United States

WITHDRAWN

Carle Cancer Center NCI Community Oncology Research Program

Urbana, Illinois, 61801, United States

WITHDRAWN

University of Iowa/Holden Comprehensive Cancer Center

Iowa City, Iowa, 52242, United States

NOT YET RECRUITING

Cancer Center of Kansas - Wichita

Wichita, Kansas, 67214, United States

WITHDRAWN

Metro Minnesota Community Oncology Research Consortium

Saint Louis Park, Minnesota, 55416, United States

COMPLETED

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

WITHDRAWN

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, 37232, United States

RECRUITING

Saint Vincent Hospital Cancer Center Green Bay

Green Bay, Wisconsin, 54301, United States

RECRUITING

Aurora Cancer Care-Milwaukee West

Wauwatosa, Wisconsin, 53226, United States

WITHDRAWN

MeSH Terms

Interventions

Paclitaxel; Taxes; Ramucirumab; Trifluridine; trifluridine tipiracil drug combination

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Economics; Health Care Economics and Organizations; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Thymidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Mohamad B Sonbol

  Academic and Community Cancer Research United

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2020
• First Posted: December 9, 2020
• Study Start: June 16, 2021
• Primary Completion: July 31, 2024
• Study Completion (Estimated): May 31, 2026
• Last Updated: April 1, 2024

Record last verified: 2023-05

Locations

US (15)