Clinical trial for Clinical Stage III Gastric Cancer AJCC v8
Official title Ramucirumab and Trifluridine/Tipiracil or Paclitaxel for the Treatment of Patients With Previously Treated Advanced Gastric or Gastroesophageal Junction Cancer
ClinicalTrials.gov ID: NCT04660760
What this study is testing
What is Paclitaxel?
Paclitaxel is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for clinical stage iii gastric cancer ajcc v8.
Also referred to as Anzatax, Asotax.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 3 years
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
You likely can't join if
- Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus...
- 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...
- Previous treatment with TAS-102 or ramucirumab
See the full eligibility criteria
Who can join
- 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...
- Urinary protein 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 =\ = 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)
What rules you out
- 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...
- 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...
- 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...
- 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...
- 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...
- Receiving chronic antiplatelet therapy, including dipyridamole or clopidogrel, or similar agents. NOTE: Once-daily aspirin use (maximum dose 325 mg/day) is permitted
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Scottsdale, Arizona, United States
- Tucson, Arizona, United States
- Los Angeles, California, United States
- Jacksonville, Florida, United States
- Weston, Florida, United States
- Atlanta, Georgia, United States
- Urbana, Illinois, United States
- Iowa City, Iowa, United States
- Wichita, Kansas, United States
- Saint Louis Park, Minnesota, United States
- Omaha, Nebraska, United States
- Nashville, Tennessee, United States
- Green Bay, Wisconsin, United States
- Wauwatosa, Wisconsin, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 3 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Scottsdale, Arizona, United States; Tucson, Arizona, United States; Los Angeles, California, United States; Jacksonville, Florida, United States; Weston, Florida, United States and 9 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.