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P021

Peptide 021, GLXC-21260

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Studies 37
Trials 57
Completed PHASE1 INTERVENTIONAL NCT01958372

Radiation Therapy, Chemotherapy, and Soy Isoflavones in Treating Patients With Stage IIIA-IIIB Non-Small Cell Lung Cancer

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

This phase I trial studies the side effects of soy isoflavones when given together with radiation therapy and chemotherapy in treating patients with stage IIIA-IIIB non-small cell lung cancer. Radiation therapy uses high energy x rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, pemetrexed sodium, and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Soy isoflavones may help radiation therapy, cisplatin, pemetrexed sodium, and etoposide work better by making tumor cells more sensitive to the drug. Soy isoflavones may also protect normal cells from the side effects of radiation therapy and chemotherapy.

Detailed Description

PRIMARY OBJECTIVES: I. To evaluate the safety of adding oral soy isoflavone to concurrent chemotherapy and radiotherapy for the treatment of patients with unresectable stage III non-small cell lung cancer (NSCLC). OUTLINE: Patients are assigned to 1 of 2 treatment groups. GROUP I (SQUAMOUS CELL HISTOLOGY): Patients receive etoposide intravenously (IV) over 1 hour on days 1-5 and 29-33, cisplatin IV over 1 hour on days 1, 8, 29, and 36, and undergo radiation therapy (RT) 5 days a week for 6.6 weeks. Within 48 hours of initiating treatment, patients receive soy isoflavones orally (PO) daily on days 1-90. GROUP II (NON-SQUAMOUS CELL HISTOLOGY): Patients receive pemetrexed disodium IV over 10 minutes on days 1, 22, and 43 and cisplatin IV over 1 hour on days 1, 22, and 43. Patients also undergo RT and receive soy isoflavones as in Group I. After completion of study treatment, patients are followed up at 4 weeks and then every 4 months for 1 year, every 6 months for 1 year, and then yearly thereafter.

Interventions

Name: soy isoflavones
Type: DIETARY_SUPPLEMENT
Description: Given PO
Name: cisplatin
Type: DRUG
Description: Given IV
Name: etoposide
Type: DRUG
Description: Given IV
Name: pemetrexed disodium
Type: DRUG
Description: Given IV
Name: radiation therapy
Type: RADIATION
Description: Undergo RT

Primary Outcomes

Measure: Safety, in terms of dose-limiting toxicity of adding oral soy isoflavone supplementation to concurrent chemotherapy and radiotherapy, graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4
TimeFrame: Up to 90 days
Description:
Measure: Survival proportion
TimeFrame: 1 year
Description:

Trial Information

NCT ID

NCT01958372

Status

Completed

Study Type

INTERVENTIONAL

Phases

PHASE1

Sponsor

Barbara Ann Karmanos Cancer Institute

Last Updated

December 15, 2025