Actively Recruiting
Ramucirumab and Trifluridine/Tipiracil or Paclitaxel for the Treatment of Patients With Previously Treated Advanced Gastric or Gastroesophageal Junction Cancer
Led by Academic and Community Cancer Research United · Updated on 2024-04-01
116
Participants Needed
15
Research Sites
258 weeks
Total Duration
On this page
Sponsors
A
Academic and Community Cancer Research United
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Ramucirumab and Trifluridine/Tipiracil or Paclitaxel for the Treatment of Patients With Previously Treated Advanced Gastric or Gastroesophageal Junction Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histological or cytological confirmation of adenocarcinoma of the stomach or gastroesophageal junction
- Locally advanced unresectable or metastatic disease that progressed within 180 days since last treatment
- One or more measurable or nonmeasurable evaluable lesions per RECIST
- Planned for second line treatment after failing or intolerance to prior standard chemotherapies including fluoropyrimidine and platinum, and trastuzumab if HER2-positive
- ECOG performance status of 0 or 1
- Ability to swallow oral medications
- Absolute neutrophil count (ANC) ≥ 1500/mm³ within 7 days before registration
- Platelet count ≥ 100,000/mm³ within 7 days before registration
- Hemoglobin ≥ 9.0 g/dL within 7 days before registration
- Total bilirubin ≤ 1.5 times upper limit of normal within 7 days before registration
- AST and ALT ≤ 3 times upper limit of normal (≤ 5 times if liver metastasis) within 7 days before registration
- INR ≤ 1.5 times upper limit of normal and PTT ≤ 5 seconds above upper limit of normal unless on anticoagulation therapy within 7 days before registration
- For patients on warfarin, stable coagulation profile and INR ≤ 3.0 before first dose
- Stable dose of oral anticoagulants or low molecular weight heparin if receiving full-dose anticoagulation
- Urinary protein ≤ 1+ on dipstick or ≤ 1000 mg protein in 24-hour urine if higher than 1+
- Creatinine ≤ 1.5 times upper limit of normal or creatinine clearance ≥ 50 mL/min within 7 days before registration
- Negative pregnancy test within 7 days before registration for women of childbearing potential
- Ability to complete questionnaires independently or with assistance
- Provided informed written consent within 28 days before registration
- Willing to return for follow-up visits during active monitoring phase
- If sexually active, postmenopausal, surgically sterile, or using effective contraception due to unknown teratogenicity of ramucirumab
You will not qualify if you...
- Pregnant or nursing women
- Women of childbearing potential unwilling to use adequate contraception
- Severe co-morbid systemic illnesses or other severe concurrent diseases that interfere with safety assessment
- Previous treatment with TAS-102 or ramucirumab
- Previous taxane therapy within 180 days before registration
- Grade 3-4 gastrointestinal bleeding within 90 days before registration
- History of deep vein thrombosis, pulmonary embolism, or significant thromboembolism within 90 days before registration
- Arterial thromboembolic events (such as heart attack, stroke) within 180 days before registration
- History of gastrointestinal perforation or fistula within 180 days or risk factors for perforation
- Serious or nonhealing wounds, ulcers, or bone fractures within 28 days before registration
- Major surgery within 28 days before first dose or minor surgery/venous access placement within 7 days before registration
- Planned major surgery during the clinical trial
- Cirrhosis at Child-Pugh B level or worse, or cirrhosis with hepatic encephalopathy or meaningful ascites
- Uncontrolled or poorly-controlled hypertension despite treatment for at least 4 weeks
- Immunocompromised patients known to be HIV positive on antiretroviral therapy
- Uncontrolled intercurrent illness including active infection, symptomatic heart failure, unstable angina, arrhythmia, or psychiatric/social conditions limiting compliance
- Receiving other investigational agents for the primary cancer
- Other active cancers within 3 years except non-melanotic skin cancer or cervical carcinoma in situ
- Receiving chronic antiplatelet therapy except once-daily aspirin up to 325 mg/day allowed
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 15 locations
1
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States, 35233
Not Yet Recruiting
2
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
Actively Recruiting
3
Arizona Clinical Research Center
Tucson, Arizona, United States, 85715
Withdrawn
4
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Actively Recruiting
5
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224-9980
Actively Recruiting
6
Cleveland Clinic-Weston
Weston, Florida, United States, 33331
Actively Recruiting
7
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Withdrawn
8
Carle Cancer Center NCI Community Oncology Research Program
Urbana, Illinois, United States, 61801
Withdrawn
9
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, United States, 52242
Not Yet Recruiting
10
Cancer Center of Kansas - Wichita
Wichita, Kansas, United States, 67214
Withdrawn
11
Metro Minnesota Community Oncology Research Consortium
Saint Louis Park, Minnesota, United States, 55416
Completed
12
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Withdrawn
13
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
14
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, United States, 54301
Actively Recruiting
15
Aurora Cancer Care-Milwaukee West
Wauwatosa, Wisconsin, United States, 53226
Withdrawn
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here