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.
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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
11
Given PO
Given IV
Given IV
Given IV
Undergo RT
Karmanos Cancer Institute at McLaren Bay Region
Bay City, Michigan, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Karmanos Cancer Institute at McLaren Lapeer Region
Lapeer, Michigan, United States
Karmanos Cancer Institute at McLaren Central Michigan
Mount Pleasant, Michigan, United States
Karmanos Cancer Institute at McLaren Northern
Petoskey, Michigan, United States
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
Time frame: Up to 90 days
Survival proportion
Time frame: 1 year
Grade 3-4 toxicity rate graded according to NCI CTCAE version 4.0
Point and exact confidence interval estimates of the grade 3-4 toxicity rate will be computed for each type of toxicity encountered.
Time frame: 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
Point and exact confidence interval estimates of the (complete + partial) response rate will be computed.
Time frame: Up to 2 years
Time to tumor progression (TTP)
TTP will be estimated using standard Kaplan-Meier methods for censored data, from which the median and other statistics of interest will be calculated (e.g., rates at 3 months, 6 months, 12 months).
Time frame: 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)
OS will be estimated using standard Kaplan-Meier methods for censored data, from which the median and other statistics of interest will be calculated (e.g., rates at 3 months, 6 months, 12 months).
Time frame: From the date of registration to the date of death, assessed up to 2 years
Response duration
Response duration will be estimated using standard Kaplan-Meier methods for censored data, from which the median and other statistics of interest will be calculated (e.g., rates at 3 months, 6 months, 12 months).
Time frame: From the time that measurement criteria are first met for CR until the date that PD is objectively documented, assessed up to 2 years
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