NBTXR3, Chemotherapy, and Radiation Therapy for the Treatment of Esophageal Cancer

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT04615013
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Cervical Esophagus Adenocarcinoma
  • Clinical Stage II Esophageal Adenocarcinoma AJCC v8
  • Clinical Stage IIA Esophageal Adenocarcinoma AJCC v8
  • Clinical Stage IIB Esophageal Adenocarcinoma AJCC v8
  • Clinical Stage III Esophageal Adenocarcinoma AJCC v8
  • Gastroesophageal Junction Adenocarcinoma
  • Pathologic Stage II Esophageal Adenocarcinoma AJCC v8
  • Pathologic Stage IIA Esophageal Adenocarcinoma AJCC v8
  • Pathologic Stage IIB Esophageal Adenocarcinoma AJCC v8
  • Pathologic Stage III Esophageal Adenocarcinoma AJCC v8
  • Pathologic Stage IIIA Esophageal Adenocarcinoma AJCC v8
  • Pathologic Stage IIIB Esophageal Adenocarcinoma AJCC v8
  • Thoracic Esophagus Adenocarcinoma

Eligibility Criteria

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

Interventions

  • Capecitabine — DRUG
    Not applicable to this study
  • Carboplatin — DRUG
    Not applicable to this study
  • Docetaxel — DRUG
    Not applicable to this study
  • Fluorouracil — DRUG
    Not applicable to this study
  • Hafnium Oxide-containing Nanoparticles NBTXR3 — OTHER
    Given IT or IN
  • Intensity-Modulated Radiation Therapy — RADIATION
    Undergo IMRT
  • Leucovorin — DRUG
    Not applicable to this study
  • Oxaliplatin — DRUG
    Not applicable to this study
  • Paclitaxel — DRUG
    Not applicable to this study

Study Details

The purpose of this Phase I study is to determine the recommended phase 2 dose (RP2D) and safety profile of NBTXR3 activated by radiation therapy with concurrent chemotherapy for the treatment of patients with esophageal adenocarcinoma. NBTXR3 is a drug that when activated by radiation therapy, may cause targeted destruction of cancer cells. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Chemotherapy drugs, such as oxaliplatin, fluorouracil, capecitabine, docetaxel, paclitaxel, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving NBTXR3 activated by radiation therapy with concurrent chemotherapy may help control the disease.

Key Dates

Start date
Nov 23, 2020
Status verified
Apr 2026
Primary completion
Oct 31, 2027
Completion
Oct 31, 2027

Study Design

Enrollment
24 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (NBTXR3, IMRT, chemotherapy)
    Patients receive NBTXR3 IT or IN on day 1. Beginning day 15, patients undergo IMRT 5 days per week for 6 weeks for a total of 28 fractions, in the absence of disease progression or unacceptable toxicity. Concurrent with IMRT, patients receive a chemotherapy regimen consisting of either fluorouracil and oxaliplatin with or without leucovorin, oxaliplatin and capecitabine, docetaxel and fluorouracil with or without leucovorin, docetaxel and paclitaxel, or carboplatin and paclitaxel per physician discretion.

Primary Outcome Measure

Incidence of dose limiting toxicities (DLTs) [ Time Frame: Up to end of treatment visit (day 85) ]

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030
Steven H. Lin
[email protected]
713-606-3836
Steven H. Lin (PRINCIPAL_INVESTIGATOR)

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M D Anderson Cancer Center· Houston, TX

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