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