Oxaliplatin and Liposomal Irinotecan (Plus Trastuzumab for HER2-positive Disease) in Advanced Esophageal and Gastric Adenocarcinoma

Part of paid clinical trials in Madison, Wisconsin.

Sponsor
University of Wisconsin, Madison
Study ID
NCT04150640
Phase
PHASE2
Status
Recruiting
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Conditions

  • Esophageal Adenocarcinoma
  • Gastric Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nal-IRI — DRUG
    chemotherapy drug
  • Oxaliplatin — DRUG
    chemotherapy drug
  • 5-FU — DRUG
    chemotherapy drug
  • Trastuzumab — DRUG
    immunotherapy
  • Pembrolizumab — DRUG
    immunotherapy
  • Nivolumab — DRUG
    immunotherapy

Study Details

This is an open label, phase II, multi-site trial evaluating the efficacy and safety of the combination of 5-FU, oxaliplatin, nal-IRI, and immunotherapy (plus trastuzumab for HER2-positive tumors) as first-line therapy for participants with advanced Esophageal and Gastric Adenocarcinoma (EGA). The investigators hypothesize that this drug combination will be better tolerated than current first-line chemotherapy combinations for this disease.

Key Dates

Start date
Jul 13, 2020
Status verified
Jul 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
52 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1: HER2 Negative
    Participants in Cohort 1 (HER2-negative) will be treated with nal-IRI (50 mg/m\^2 - intravenously over 90 min), 5-FU (2400 mg/m\^2 over 46 hrs), and oxaliplatin (60 mg/m\^2). Each cycle is 28 days. Participants will receive treatments on day 1 and 15 of each cycle.
  • Experimental: Cohort 2: HER2 Positive
    Participants in Cohort 2 (HER2-positive) will be treated with nal-IRI (50 mg/m\^2 - intravenously over 90 min), trastuzumab (6 mg/kg C1D1, then 4 mg/kg on each subsequent treatment days), 5-FU (2400 mg/m\^2 over 46 hrs), and oxaliplatin (60 mg/m\^2). Each cycle is 28 days. Participants will receive treatments on day 1 and 15 of each cycle.
  • Experimental: Cohort 3: HER2 Negative
    Participants in Cohort 3 (HER2-negative) will be treated with nal-IRI (50 mg/m\^2 - intravenously over 90 min), 5-FU (2400 mg/m\^2 over 46 hrs), oxaliplatin (60 mg/m\^2), and nivolumab. (240 mg). Each cycle is 28 days. Participants will receive treatments on day 1 and 15 of each cycle
  • Experimental: Cohort 4: HER2 Positive
    Participants in Cohort 4 (HER2-positive) will be treated with nal-IRI (50 mg/m\^2 - intravenously over 90 min), trastuzumab (6 mg/kg C1D1, then 4 mg/kg on each subsequent treatment days), 5-FU (2400 mg/m\^2 over 46 hrs), oxaliplatin (60 mg/m\^2), and pembrolizumab (400 mg). Each cycle is 42 days. Participants will receive chemotherapy and trastuzumab treatments on day 1, 15, and 29 of each cycle. Pembrolizumab will be given on day 1 of each cycle.

Primary Outcome Measure

Cohort 1: Objective Response Rate (ORR) [ Time Frame: up to 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Wisconsin Carbone Cancer CenterMadisonWisconsin53792
Cancer Connect
[email protected]
800-622-8922
Nataliya Uboha, MD, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Wisconsin Carbone Cancer Center· Madison, WI

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