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

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ClinicalTrials.gov Identifier: NCT01958372
Recruitment Status : Completed
First Posted : October 9, 2013
Last Update Posted : November 23, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gerold Bepler, Barbara Ann Karmanos Cancer Institute

Tracking Information
First Submitted Date  ICMJE October 7, 2013
First Posted Date  ICMJE October 9, 2013
Last Update Posted Date November 23, 2020
Study Start Date  ICMJE August 2014
Actual Primary Completion Date October 9, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 7, 2013)
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 7, 2013)
  • 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.
  • 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.
  • 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).
  • 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).
  • 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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Radiation Therapy, Chemotherapy, and Soy Isoflavones in Treating Patients With Stage IIIA-IIIB Non-Small Cell Lung Cancer
Official Title  ICMJE 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Adenocarcinoma of the Lung
  • Adenosquamous Cell Lung Cancer
  • Bronchoalveolar Cell Lung Cancer
  • Large Cell Lung Cancer
  • Recurrent Non-small Cell Lung Cancer
  • Squamous Cell Lung Cancer
  • Stage IIIA Non-small Cell Lung Cancer
  • Stage IIIB Non-small Cell Lung Cancer
Intervention  ICMJE
  • Dietary Supplement: soy isoflavones
    Given PO
  • Drug: cisplatin
    Given IV
  • Drug: etoposide
    Given IV
  • Drug: pemetrexed disodium
    Given IV
  • Radiation: radiation therapy
    Undergo RT
Study Arms  ICMJE
  • 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.
    Interventions:
    • Dietary Supplement: soy isoflavones
    • Drug: cisplatin
    • Drug: etoposide
    • Radiation: radiation therapy
  • 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.
    Interventions:
    • Dietary Supplement: soy isoflavones
    • Drug: cisplatin
    • Drug: pemetrexed disodium
    • Radiation: radiation therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 19, 2020)
11
Original Estimated Enrollment  ICMJE
 (submitted: October 7, 2013)
24
Actual Study Completion Date  ICMJE November 11, 2019
Actual Primary Completion Date October 9, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01958372
Other Study ID Numbers  ICMJE 2013-021
NCI-2013-01835 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
1307012220
2013-021 ( Other Identifier: Barbara Ann Karmanos Cancer Institute )
P30CA022453 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gerold Bepler, Barbara Ann Karmanos Cancer Institute
Study Sponsor  ICMJE Barbara Ann Karmanos Cancer Institute
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Shirish Gadgeel Barbara Ann Karmanos Cancer Institute
PRS Account Barbara Ann Karmanos Cancer Institute
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP