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Protocol No. UW19029

Principal Investigator Uboha, Nataliya

Phase II

Age Group Adult

Scope National

Sponsor Type Industry; Institutional

Title Phase 2 Trial of 5-Fluorouracil, Oxaliplatin and Liposomal Irinotecan (plus Trastuzumab for HER2-positive disease) During 1st Line Treatment of Advanced Esophageal and Gastric Adenocarcinoma

Objective We want to find out if a drug called liposomal irinotecan is safe and effective when combined with standard chemotherapy for initial treatment of advanced esophageal and gastric adenocarcinoma (EGA). Liposomal irinotecan is approved by the US Food and Drug Administration (FDA) to treat other cancers, but using it to treat advanced EGA is investigational and this drug combination can only be given in a research study

Treatment
If your tumor is HER2-positive you will receive the combination chemotherapy regimen of 5-fluorouracil, oxaliplatin, and trastuzumab
If your tumor is HER2-negative you will receive the combination chemotherapy regimen of 5-fluorouracil and oxaliplatin
  • Each treatment cycle is 28 days. On Days 1 and 15 of each cycle you will receive the liposomal irinotecan and standard chemotherapy. Each drug will be given as an IV infusion through a vein

  • Description Phase II study of 5FU, oxaliplatin, liposomal Irinotecan(+ trastuzumab for Her2+) During 1st Line Treatment of Advanced Esophageal and Gastric Adenocarcinoma

    Key Eligibility
  • Age greater than or equal to 18 years at the time of consent
  • ECOG Performance Status of 0-2
  • Histological or cytological confirmed locally advanced or metastatic EGA. Known HER2 status prior to treatment initiation required
  • Measurable disease according to RECIST v1.1
  • No prior lines of systemic therapy for advanced disease
  • Patients who had received neoadjuvant or adjuvant therapy or definitive chemoradiation will be allowed to participate if recurrence occurred 6 months or longer from the completion of all prior treatments
  • Adequate organ function as defined by the protocol
  • Can not be pregnant or breastfeeding
  • Male and Female of childbearing potential must agree to adequate birth control as defined by the protocol
    EXCLUSION
  • Known hypersensitivity to 5-FU, oxaliplatin or other platinum agents, or any of the components of nal-IRI and other liposomal products
  • Known dihydropyrimidine dehydrogenase (DPD) deficiency (testing not required prior to enrolment)
  • Current therapy with other investigational agents or participation in another clinical study
  • Major surgery within 28 days or minor surgery within 14 days of the start of the study treatment, except for tumor biopsy or placement of central infusion device (port placement)
  • Radiotherapy less than 7 days prior to the start of the study treatment
  • Active infection requiring systemic therapy
  • Known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis, which is excluded regardless of clinical stability
  • Severe arterial thromboembolic events (myocardial infarction, unstable angina pectoris, stroke) less than 6 months before inclusion
  • NYHA Class III or IV congestive heart failure, ventricular arrhythmias or uncontrolled blood pressure
  • Known history of Human Immunodeficiency Virus (HIV)
  • Other active malignancy requiring treatment within the last 2 years. Exceptions include subjects with non-melanoma skin cancer, non-invasive/in situ cancer or low-risk prostate cancer requiring hormonal therapy only
  • Psychological, familial, or sociological condition potentially hampering compliance with the study protocol and follow-up schedule

  • Applicable Disease Sites Esophagus; Gastrointestinal cancers, other; Stomach

    Status Open

    Participating Institutions UW Hospital and Clinics