- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01958372
Radiation Therapy, Chemotherapy, and Soy Isoflavones in Treating Patients With Stage IIIA-IIIB Non-Small Cell Lung Cancer
Phase I Study of Thoracic Radiotherapy and Concurrent Chemotherapy With Soy Isoflavones in Stage III NSCLC (Non-Small Cell Lung Cancer) Patients
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Michigan
-
Bay City, Michigan, United States, 48706
- Karmanos Cancer Institute at McLaren Bay Region
-
Detroit, Michigan, United States, 48201
- Barbara Ann Karmanos Cancer Institute
-
Lapeer, Michigan, United States, 48446
- Karmanos Cancer Institute at McLaren Lapeer Region
-
Mount Pleasant, Michigan, United States, 48858
- Karmanos Cancer Institute at McLaren Central Michigan
-
Petoskey, Michigan, United States, 49770
- Karmanos Cancer Institute at McLaren Northern
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group I (squamous cell histology)
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.
|
Given IV
Given IV
Given PO
Undergo RT
|
Experimental: 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.
|
Given IV
Given IV
Given PO
Undergo RT
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
Up to 90 days
|
Survival proportion
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Grade 3-4 toxicity rate graded according to NCI CTCAE version 4.0
Time Frame: Up to 2 years
|
Point and exact confidence interval estimates of the grade 3-4 toxicity rate will be computed for each type of toxicity encountered.
|
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
Time Frame: Up to 2 years
|
Point and exact confidence interval estimates of the (complete + partial) response rate will be computed.
|
Up to 2 years
|
Time to tumor progression (TTP)
Time Frame: From the date of registration until the date that PD (progressive disease) or death is first reported, assessed up to 2 years
|
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).
|
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)
Time Frame: From the date of registration to the date of death, assessed up to 2 years
|
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).
|
From the date of registration to the date of death, assessed up to 2 years
|
Response duration
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
|
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).
|
From the time that measurement criteria are first met for CR until the date that PD is objectively documented, assessed up to 2 years
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Shirish Gadgeel, Barbara Ann Karmanos Cancer Institute
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Adenocarcinoma
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Adenocarcinoma of Lung
- Adenocarcinoma, Bronchiolo-Alveolar
- Molecular Mechanisms of Pharmacological Action
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Antineoplastic Agents
- Antineoplastic Agents, Phytogenic
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Folic Acid Antagonists
- Etoposide
- Cisplatin
- Pemetrexed
Other Study ID Numbers
- 2013-021 (OTHER: CCRRC)
- P30CA022453 (U.S. NIH Grant/Contract)
- NCI-2013-01835 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- 1307012220
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Stage IIIA Non-small Cell Lung Cancer
-
University of California, San FranciscoAstraZenecaActive, not recruitingStage IIIA Non-Small Cell Lung Cancer | Stage I Non-Small Cell Lung Cancer | Stage IA Non-Small Cell Lung Cancer | Stage IB Non-Small Cell Lung Cancer | Stage II Non-Small Cell Lung Cancer | Stage IIA Non-Small Cell Lung Cancer | Stage IIB Non-Small Cell Lung CancerUnited States
-
National Cancer Institute (NCI)TerminatedStage IIIA Non-small Cell Lung Cancer | Stage IA Non-small Cell Lung Cancer | Stage IB Non-small Cell Lung Cancer | Stage IIA Non-small Cell Lung Cancer | Stage IIB Non-small Cell Lung CancerUnited States
-
National Cancer Institute (NCI)Not yet recruitingStage IIIA Non-small Cell Lung Cancer | Stage IA Non-small Cell Lung Cancer | Stage IB Non-small Cell Lung Cancer | Stage IIA Non-small Cell Lung Cancer | Stage IIB Non-small Cell Lung CancerCanada
-
City of Hope Medical CenterNational Cancer Institute (NCI)CompletedStage IIA Rectal Cancer | Stage IIB Rectal Cancer | Stage IIC Rectal Cancer | Stage IIIA Rectal Cancer | Stage IIIB Rectal Cancer | Stage IIIC Rectal Cancer | Stage IIIA Non-small Cell Lung Cancer | Stage IIIB Non-small Cell Lung Cancer | Stage IIIA Colon Cancer | Stage IIIB Colon Cancer | Stage IIIC Colon... and other conditionsUnited States
-
Peking UniversityMerck Sharp & Dohme LLC; Cancer Institute and Hospital, Chinese Academy of... and other collaboratorsRecruitingStage IIIA Non-small Cell Lung Cancer | Stage IIA Non-small Cell Lung Cancer | Stage IIB Non-small Cell Lung Cancer | Stage IIIB(N2) Non-small Cell Lung CancerChina
-
Washington University School of MedicineActive, not recruitingStage IIIA Non-small Cell Lung Cancer | Stage IIIB Non-small Cell Lung Cancer | Stage IIB Non-Small Cell Lung Cancer | Stage IIIC Non-Small Cell Lung CancerUnited States
-
H. Lee Moffitt Cancer Center and Research InstituteNestle Health ScienceWithdrawnNSCLC | Non Small Cell Lung Cancer | Non-small Cell Lung Cancer | NSCLC Stage IIIB | Non-small Cell Lung Cancer Stage IIIB | NSCLC, Stage IIIA | Non-small Cell Lung Cancer Stage ⅢAUnited States
-
Karen KellyBristol-Myers Squibb; National Cancer Institute (NCI); TransgeneCompletedStage IIIA Non-Small Cell Lung Cancer | Stage IIIB Non-Small Cell Lung Cancer | Recurrent Non-Small Cell Lung Carcinoma | Stage IV Non-Small Cell Lung Cancer | Stage I Non-Small Cell Lung Cancer | Stage II Non-Small Cell Lung CancerUnited States
-
National Cancer Institute (NCI)RecruitingStage IIA Lung Cancer AJCC v8 | Stage IIB Lung Cancer AJCC v8 | Stage IIIA Lung Cancer AJCC v8 | Stage IIIB Lung Cancer AJCC v8 | Stage IB Lung Non-Small Cell Carcinoma AJCC v7 | Stage II Lung Non-Small Cell Cancer AJCC v7 | Stage IIIA Lung Non-Small Cell Cancer AJCC v7United States, Guam, Puerto Rico
-
Emory UniversityWashington University Siteman Cancer CenterActive, not recruitingStage IIIA Non-small Cell Lung Cancer | Stage IIIB Non-small Cell Lung Cancer | Stage IIA Non-small Cell Lung Cancer | Stage IIB Non-small Cell Lung CancerUnited States
Clinical Trials on etoposide
-
Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator...UnitedHealthcareActive, not recruitingSmall Cell Lung CancerUnited States
-
University Hospital, BonnCompletedEpendymomas | Recurrent Brain Tumors | Supratentorial PNETs | MedulloblastomasGermany
-
Sun Yat-sen UniversityRecruitingSmall Cell Lung CarcinomaChina
-
Guizhou Medical UniversityUnknownSmall-cell Lung CancerChina
-
Third Military Medical UniversityUnknownExtensive-stage Small Cell Lung Cancer
-
Jiangsu HengRui Medicine Co., Ltd.Enrolling by invitation
-
CephalonWithdrawn
-
Qingdao UniversityUnknownProgression Free SurvivalChina
-
Annick DesjardinsAstraZenecaCompletedGlioblastoma | GliosarcomaUnited States
-
Third Military Medical UniversityNot yet recruiting