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



Status:Recruiting
Conditions:Lung Cancer, Lung Cancer, Cancer, Cancer, Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:August 2014
End Date:December 2016

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

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.

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
We found this trial at
5
sites
Lapeer, Michigan 48446
Principal Investigator: Sai Bikkina, M.D.
Phone: 810-245-5326
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4100 John R
Detroit, Michigan 48201
800-527-6266
Principal Investigator: Shirish M. Gadgeel
Phone: 313-576-8753
Barbara Ann Karmanos Cancer Institute Karmanos is based in southeast Michigan, in midtown Detroit, and...
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Bay City, Michigan 48706
Principal Investigator: David Cook, M.D.
Phone: 989-667-2389
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Bay City, MI
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Mt. Pleasant, Michigan 48858
Principal Investigator: Somdev Roy, M.D.
Phone: 979-953-5178
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Mt. Pleasant, MI
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Petoskey, Michigan 49770
Principal Investigator: Thomas Boike, M.D.
Phone: 231-487-7380
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Petoskey, MI
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