RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2021-06-16

Study Completion:2026-05-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04660760

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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)	* 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 * Uncontrolled or poorly-controlled hypertension (\>= 150 mmHg systolic or \>= 90 mmHg diastolic for \>= 4 weeks) despite standard medical management * Immunocompromised and known to be human immunodeficiency virus (HIV) positive and currently receiving antiretroviral therapy * NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm * Other active malignancy =\< 3 years prior to registration. EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix. NOTE: If there is a history of prior malignancy, they must not be receiving other specific treatment for their cancer * Receiving chronic antiplatelet therapy, including dipyridamole or clopidogrel, or similar agents. NOTE: Once-daily aspirin use (maximum dose 325 mg/day) is permitted

Inclusion Criteria

Exclusion Criteria

* 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)

* 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
* Uncontrolled or poorly-controlled hypertension (\>= 150 mmHg systolic or \>= 90 mmHg diastolic for \>= 4 weeks) despite standard medical management
* Immunocompromised and known to be human immunodeficiency virus (HIV) positive and currently receiving antiretroviral therapy
* NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
* Other active malignancy =\< 3 years prior to registration. EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix. NOTE: If there is a history of prior malignancy, they must not be receiving other specific treatment for their cancer
* Receiving chronic antiplatelet therapy, including dipyridamole or clopidogrel, or similar agents. NOTE: Once-daily aspirin use (maximum dose 325 mg/day) is permitted

Contacts and Locations

Principal Investigator

Mohamad B Sonbol

PRINCIPAL_INVESTIGATOR

Academic and Community Cancer Research United

Study Locations (Sites)

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, 35233

United States

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259

United States

Arizona Clinical Research Center

Tucson, Arizona, 85715

United States

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033

United States

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980

United States

Cleveland Clinic-Weston

Weston, Florida, 33331

United States

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, 30322

United States

Carle Cancer Center NCI Community Oncology Research Program

Urbana, Illinois, 61801

United States

University of Iowa/Holden Comprehensive Cancer Center

Iowa City, Iowa, 52242

United States

Cancer Center of Kansas - Wichita

Wichita, Kansas, 67214

United States

Metro Minnesota Community Oncology Research Consortium

Saint Louis Park, Minnesota, 55416

United States

University of Nebraska Medical Center

Omaha, Nebraska, 68198

United States

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, 37232

United States

Saint Vincent Hospital Cancer Center Green Bay

Green Bay, Wisconsin, 54301

United States

Aurora Cancer Care-Milwaukee West

Wauwatosa, Wisconsin, 53226

United States

Collaborators and Investigators

Sponsor: Academic and Community Cancer Research United

Mohamad B Sonbol, PRINCIPAL_INVESTIGATOR, Academic and Community Cancer Research United

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-06-16

Study Completion Date2026-05-31

Study Record Updates

Study Start Date2021-06-16

Study Completion Date2026-05-31

Terms related to this study

Additional Relevant MeSH Terms

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