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Chemotherapy

NBTXR3 + Chemoradiation for Esophageal Cancer

Phase 1

Recruiting

Led By Steven H Lin

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status 0-2

Medically able to receive chemoradiation. Following chemotherapy regimens are allowed: Oxaliplatin and fluorouracil (5-FU) or capecitabine, Docetaxel and/or 5-FU or paclitaxel, Carboplatin and paclitaxel

Must not have

Known uncontrolled (grade >= 2) or active esophageal or gastric ulcer disease within 28 days of enrollment

Esophageal cancer with radiographic evidence of metastases at screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from nbtxr3 injection to local recurrence, local progression, distant progression, confirmed radiographically (recist version 1.1), or death from any cause, whichever occurs first, assessed up to 1 year

Awards & highlights

All Individual Drugs Already Approved

Approved for 10 Other Conditions

No Placebo-Only Group

Summary

This trial will test the safety of NBTXR3 activated by radiation therapy given with concurrent chemotherapy in patients with esophageal adenocarcinoma.

Who is the study for?

This trial is for adults with esophageal adenocarcinoma stages II-III who haven't had prior treatments for their cancer. They must have a certain level of blood cells, organ function, and be able to undergo specific diagnostic tests. Pregnant or breastfeeding women can't participate, nor those with other active cancers or serious medical conditions.

What is being tested?

The study is testing NBTXR3 nanoparticles activated by radiation therapy alongside standard chemotherapy drugs (like oxaliplatin and fluorouracil) to see if this combination better controls esophageal cancer compared to current treatments.

What are the potential side effects?

Potential side effects include typical chemotherapy-related issues like nausea, fatigue, low blood cell counts leading to increased infection risk; radiation may cause skin irritation or difficulty swallowing. The new drug's side effects are being studied but could involve similar reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can take care of myself and am up and about more than half of my waking hours.

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I can undergo chemoradiation and can take specific chemotherapy drugs.

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My cancer is confirmed in the esophagus or where it meets the stomach.

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My cancer has spread to lymph nodes that are larger than 15 mm.

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I have 1 to 4 measurable tumors in my esophagus.

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My condition is stage II-III esophageal adenocarcinoma.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have severe, active ulcers in my esophagus or stomach.

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My esophageal cancer has spread, as shown in scans.

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I am allergic to iodine or gadolinium IV contrasts.

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I do not have an active, uncontrolled HIV or hepatitis B/C infection.

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I am not pregnant or breastfeeding.

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I have had surgery to remove an esophageal tumor.

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I do not have any severe illnesses that could interfere with the treatment.

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I have received treatment for esophageal cancer before.

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I am using effective birth control methods during the study.

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I have a history of specific esophageal or tracheoesophageal conditions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from nbtxr3 injection to local recurrence, local progression, distant progression, confirmed radiographically (recist version 1.1), or death from any cause, whichever occurs first, assessed up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from nbtxr3 injection to local recurrence, local progression, distant progression, confirmed radiographically (recist version 1.1), or death from any cause, whichever occurs first, assessed up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and from nbtxr3 injection to local recurrence, local progression, distant progression, confirmed radiographically (recist version 1.1), or death from any cause, whichever occurs first, assessed up to 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of dose limiting toxicities (DLTs)

Maximum tolerated dose and recommended phase 2 dose (RP2D)

Secondary study objectives

Distant progression-free survival

Feasibility of NBTXR3 injection in the esophageal tumor and involved regional lymph nodes

Incidence of NBTXR3/radiation therapy related late onset toxicities

+5 more

Other study objectives

Changes in radiomic measurements

Concordance of cell free deoxyribonucleic acid (DNA)

Disease control rate

+4 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (NBTXR3, IMRT, chemotherapy)Experimental Treatment9 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fluorouracil

FDA approved

Paclitaxel

FDA approved

Carboplatin

FDA approved

Docetaxel

FDA approved