Study on Folfox, Irinotecan, and Chemotherapy with Radiation for Esophageal Cancer

Sponsor: Massachusetts General Hospital

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04656041

Provider View

This clinical trial is exploring how a new drug, Liposomal Irinotecan, combined with standard chemotherapy and radiation treatments, affects esophageal and gastroesophageal cancer.

Patient Parameters

Program Overview

The purpose of this study is to see how well a new drug, Liposomal Irinotecan, works when used with standard treatments like FOLFOX (a combination of chemotherapy drugs), carboplatin, paclitaxel, and radiation therapy for treating esophageal and gastroesophageal cancer. The study will involve about 40 participants and aims to test the safety and effectiveness of this new combination treatment.

Description

This study involves several steps, including checking if participants are eligible, providing the study treatment, and having follow-up visits. The standard treatments used in this study are FOLFOX (which includes leucovorin calcium, 5-Fluorouracil, and oxaliplatin), carboplatin, paclitaxel, and radiation therapy. The new treatment being tested is Liposomal Irinotecan.

This is a Phase II clinical trial, which means it is testing the safety and effectiveness of Liposomal Irinotecan to see if it can help treat esophageal and gastroesophageal cancer. Although Liposomal Irinotecan is not yet approved by the FDA for this specific type of cancer, it is approved for other uses. The other treatments in this study, like FOLFOX, carboplatin, and paclitaxel, are already approved for treating this type of cancer.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of certain types of esophageal or gastroesophageal cancer.
  • Must be 18 years or older.
  • Must be in good overall health, with a performance status score of 0 or 1.
  • Must have a life expectancy of more than 3 months.
  • Must have adequate organ and bone marrow function, as shown by specific blood test results.
  • Women of childbearing potential and men must agree to use effective birth control during the study and for 30 days after the last treatment.
  • Women must have a negative pregnancy test before starting the study.
  • Must be able to understand and sign a consent form to participate.

Exclusion Criteria

  • Cannot have cancer that has spread to other parts of the body, except for certain lymph nodes.
  • Cannot have had previous chemotherapy, targeted therapy, or radiation for esophageal cancer.
  • Cannot have had other invasive cancers in the last five years, except for certain skin cancers.
  • Cannot have taken any investigational drugs within four weeks before starting the study.
  • Cannot have serious health conditions that would interfere with the study, like heart or lung problems.
  • Cannot have uncontrolled seizures or mental health issues that would prevent understanding the study.
  • Cannot be pregnant or breastfeeding.
  • Cannot have had major surgery within four weeks before starting the study.
  • Cannot take cimetidine, a specific medication, during the study.
  • Cannot have uncontrolled bleeding disorders.
  • Cannot have had certain chemotherapy drugs before, unless under specific conditions.
  • Cannot be allergic to the study drugs or have a known deficiency that affects drug processing.

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