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

NCT01958372 | Completed Phase 1

• 4 other identifiers: 2013-021NCI-2013-018351307012220P30CA022453
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 5

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.

Conditions

Adenocarcinoma of the Lung; Adenosquamous Cell Lung Cancer; Bronchoalveolar Cell Lung Cancer; Large Cell Lung Cancer; Recurrent Non-small Cell Lung Cancer; Squamous Cell Lung Cancer; Stage IIIA Non-small Cell Lung Cancer; Stage IIIB Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

• 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

  Up to 90 days

• Survival proportion

  1 year

Secondary Outcomes (5)

• Grade 3-4 toxicity rate graded according to NCI CTCAE version 4.0

  Up to 2 years

• Response (complete response [CR] and partial response [PR]) rate according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

  Up to 2 years

• Time to tumor progression (TTP)

  From the date of registration until the date that PD (progressive disease) or death is first reported, assessed up to 2 years

• Overall survival (OS)

  From the date of registration to the date of death, assessed up to 2 years

• Response duration

  From the time that measurement criteria are first met for CR until the date that PD is objectively documented, assessed up to 2 years

Study Arms (2)

Group I (squamous cell histology)

EXPERIMENTAL

Patients receive etoposide 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 RT 5 days a week for 6.6 weeks. Within 48 hours of initiating treatment, patients receive soy isoflavones PO daily on days 1-90.

Dietary Supplement: soy isoflavones; Drug: cisplatin; Drug: etoposide; Radiation: radiation therapy

Group II (non-squamous cell histology)

EXPERIMENTAL

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.

Dietary Supplement: soy isoflavones; Drug: cisplatin; Drug: pemetrexed disodium; Radiation: radiation therapy

Interventions

soy isoflavones DIETARY_SUPPLEMENT

Given PO

Group I (squamous cell histology); Group II (non-squamous cell histology)

cisplatin DRUG

Given IV

Group I (squamous cell histology); Group II (non-squamous cell histology)

etoposide DRUG

Given IV

Group I (squamous cell histology)

pemetrexed disodium DRUG

Given IV

Group II (non-squamous cell histology)

radiation therapy RADIATION

Undergo RT

Group I (squamous cell histology); Group II (non-squamous cell histology)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologic or cytologic diagnosis of stage III non-small cell lung cancer; patients will need to meet the following criteria for stage IIIA or IIIB diagnosis:
• IIIA
• Histologic or cytologic diagnosis of ipsilateral mediastinal lymph node involvement, or
• Tumors greater than 7 cm or with chest wall invasion, or involvement of one of the following diaphragm, phrenic nerve, mediastinal pleura or parietal pericardium with hilar or mediastinal lymph node involvement
• More than one mediastinal lymph node enlarged on computed tomography (CT) scan and the same lymph nodes positive on positron emission tomography (PET) scans or
• Paralyzed left vocal cord with separate lung primary distinct from the aorto-pulmonary lymph nodes on the CT scan
• IIIB
• Histologic or cytologic diagnosis of N3 lymph node involvement; or
• Enlarged N3 lymph nodes on CT scan that are positive on PET scan as well; patient must not have extension of lymph node involvement to cervical lymph nodes other than supraclavicular lymph nodes; or
• Right sided primary with left vocal cord paralysis; or
• Evidence of tumor extension into the mediastinum and/or mediastinal structures either at the time of mediastinoscopy, bronchoscopy or on CT scans
• Patients with a nodules in the same lung but no other areas of involvement
• Patients with prior surgically resected stage I NSCLC who did not receive any adjuvant therapy, who now have stage IIIA or B NSCLC will be eligible
• Southwestern Oncology Group (SWOG) performance status 0 or 1
• Absolute neutrophil count of \> 1.5 x 10\^9/L

You may not qualify if:

• Prior chemotherapy, radiation for any malignancy in which they received any thoracic radiotherapy
• Patients with concurrent malignancy; patients with prior or concurrent malignancy will be allowed as long as the treating physician considers it unlikely to impact the clinical outcome of the patient
• Patients with peripheral neuropathy \> 2
• Serious medical illness including but not limited to uncontrolled congestive heart failure, uncontrolled angina, myocardial infarction or cerebrovascular event with 6 months of registration, history of chronic active hepatitis or history of human immunodeficiency virus (HIV) or an active bacterial infection will not be eligible
• Inability or unwillingness to take folic acid or vitamin B12 or dexamethasone
• Pregnant or lactating women; all pre-menopausal and peri-menopausal women should have a urine test for pregnancy within a week of starting therapy; all patients of child bearing potential should agree to use an effective contraceptive method
• Patients should not participate in any other therapeutic investigational study while taking part in this study
• Patients on warfarin will not be allowed on the study; patient on low molecular heparin or anti direct factor Xa inhibitor (Xa) drugs will be allowed
• Patients with a soy allergy will be excluded

Sponsors & Collaborators

• Barbara Ann Karmanos Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (5)

Karmanos Cancer Institute at McLaren Bay Region

Bay City, Michigan, 48706, United States

Location

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Karmanos Cancer Institute at McLaren Lapeer Region

Lapeer, Michigan, 48446, United States

Location

Karmanos Cancer Institute at McLaren Central Michigan

Mount Pleasant, Michigan, 48858, United States

Location

Karmanos Cancer Institute at McLaren Northern

Petoskey, Michigan, 49770, United States

Location

MeSH Terms

Conditions

Adenocarcinoma of Lung; Adenocarcinoma, Bronchiolo-Alveolar; Carcinoma, Non-Small-Cell Lung

Interventions

Soybean Proteins; Cisplatin; Etoposide; Pemetrexed; Radiotherapy

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Plant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Plant Proteins, Dietary; Dietary Proteins; Food; Diet, Food, and Nutrition; Physiological Phenomena; Soy Foods; Vegetable Products; Vegetables; Food and Beverages; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Dicarboxylic; Therapeutics

Study Officials

• Shirish Gadgeel

  Barbara Ann Karmanos Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 7, 2013
• First Posted: October 9, 2013
• Study Start: August 1, 2014
• Primary Completion: October 9, 2017
• Study Completion: November 11, 2019
• Last Updated: November 23, 2020

Record last verified: 2020-11

Locations

US (5)