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

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Brief Title

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

Official Title

Phase I Study of Thoracic Radiotherapy and Concurrent Chemotherapy With Soy Isoflavones in Stage III NSCLC (Non-Small Cell Lung Cancer) Patients

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.
    

Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

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

Secondary Outcome

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

Condition

Adenocarcinoma of the Lung

Intervention

soy isoflavones

Study Arms / Comparison Groups

 Group I (squamous cell histology)
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Dietary Supplement

Estimated Enrollment

11

Start Date

August 2014

Completion Date

November 11, 2019

Primary Completion Date

October 9, 2017

Eligibility Criteria

        Inclusion Criteria:

          -  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

          -  Platelet count > 100,000 x 10^9/L

          -  Serum creatinine =< 1.5 times the institutional upper limit of normal (ULN)

          -  Calculated creatinine clearance (Cockcroft-Gault formula) of >= 45mL/min

          -  Serum bilirubin > ULN

          -  Transaminases (serum glutamic oxaloacetic transaminase [SGOT] and/or serum glutamate
             pyruvate transaminase [SGPT]) > 1.5 times institutional ULN

          -  Alkaline phosphatase >= 2.5 times ULN

          -  Forced expiratory volume in one second (FEV1) of >= 1 liter and diffusion capacity of
             carbon monoxide (DLCO) >= 40% of predicted

          -  Patient should undergo brain imaging (CT scan or magnetic resonance imaging [MRI ]) to
             rule out brain metastases

          -  Signed informed consent that details the investigational nature of the study according
             to institutional and federal guidelines

          -  Registered with Clinical Trials Office at Karmanos Cancer Institute/Wayne State
             University

        Exclusion Criteria:

          -  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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Shirish Gadgeel, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01958372

Organization ID

2013-021

Secondary IDs

NCI-2013-01835

Responsible Party

Principal Investigator

Study Sponsor

Barbara Ann Karmanos Cancer Institute

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Shirish Gadgeel, Principal Investigator, Barbara Ann Karmanos Cancer Institute


Verification Date

November 2020