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Methoxyamine Hydrochloride, Pemetrexed Disodium, Cisplatin, and Radiation Therapy in Treating Patients With Stage IIIA-IV Non-small Cell Lung Cancer

NCT02535325 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2022-06-30

No results posted yet for this study

Summary

This phase I trial studies the side effects and best dose of methoxyamine when given together with pemetrexed disodium, cisplatin, and radiation therapy in treating patients with stage IIIA-IV non-small cell lung cancer. Drugs used in chemotherapy, such as methoxyamine hydrochloride, pemetrexed disodium, and cisplatin, 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. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving methoxyamine hydrochloride together with pemetrexed disodium, cisplatin, and radiation therapy may kill more tumor cells.

Conditions

  • Locally Advanced Lung Non-Squamous Non-Small Cell Carcinoma
  • Stage III Lung Adenocarcinoma AJCC v7
  • Stage III Lung Large Cell Carcinoma AJCC v7
  • Stage III Lung Non-Small Cell Cancer AJCC v7
  • Stage IIIA Lung Adenocarcinoma AJCC v7
  • Stage IIIA Lung Large Cell Carcinoma AJCC v7
  • Stage IIIA Lung Non-Small Cell Cancer AJCC v7
  • Stage IIIB Lung Adenocarcinoma AJCC v7
  • Stage IIIB Lung Large Cell Carcinoma AJCC v7
  • Stage IIIB Lung Non-Small Cell Cancer AJCC v7
  • Stage IV Lung Adenocarcinoma AJCC v7
  • Stage IV Lung Large Cell Carcinoma AJCC v7
  • Stage IV Lung Non-Small Cell Cancer AJCC v7

Interventions

RADIATION

3-Dimensional Conformal Radiation Therapy

Undergo 3-D conformal RT

DRUG

Cisplatin

Given IV

RADIATION

Intensity-Modulated Radiation Therapy

Undergo IMRT

DRUG

Methoxyamine

Given PO

DRUG

Methoxyamine Hydrochloride

Given PO

DRUG

Pemetrexed

Given IV

DRUG

Pemetrexed Disodium

Given IV

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Tithi Biswas · Case Western Reserve University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2020-02-27
Completion
2022-06-14

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02535325 on ClinicalTrials.gov