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Adenocarcinoma of the LungPhase 1NCT01958372

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

A Phase 1 study testing soy isoflavones, cisplatin and etoposide in people with Adenocarcinoma of the Lung and Adenosquamous Cell Lung Cancer, run by Barbara Ann Karmanos Cancer Institute at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
soy isoflavones, cisplatin and etoposide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11 participants
Where
5 sitesUnited States
Study dates
Aug 2014to 11 Nov 2019
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Karmanos Cancer Institute at McLaren Bay Region

    Bay City, Michigan, 48706

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Karmanos Cancer Institute at McLaren Lapeer Region

    Lapeer, Michigan, 48446

  • Karmanos Cancer Institute at McLaren Central Michigan

    Mount Pleasant, Michigan, 48858

  • Karmanos Cancer Institute at McLaren Northern

    Petoskey, Michigan, 49770

Other trials in United States

About this study

Official title: 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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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.

Being tested
soy isoflavones, cisplatin, etoposide, pemetrexed disodium, radiation therapy
Medical subject headings
Adenocarcinoma of Lung, Adenocarcinoma, Bronchiolo-Alveolar, Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • soy isoflavonesDietary supplement

    Given PO

  • cisplatinDrug

    Given IV

  • etoposideDrug

    Given IV

  • pemetrexed disodiumDrug

    Given IV

  • radiation therapyRadiation

    Undergo RT

Study groups in NCT01958372
Study groupRoleWhat they receive
Group I (squamous cell histology)ExperimentalPatients 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.
Receives: Dietary Supplement: soy isoflavones; Drug: cisplatin; Drug: etoposide; Radiation: radiation therapy
Group II (non-squamous cell histology)ExperimentalPatients 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.
Receives: Dietary Supplement: soy isoflavones; Drug: cisplatin; Drug: pemetrexed disodium; Radiation: radiation therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Up to 90 days

  2. Survival proportion

    Measured: 1 year

Secondary outcomes (5)

  1. 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.

    Measured: Up to 2 years

  2. 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.

    Measured: Up to 2 years

  3. 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).

    Measured: From the date of registration until the date that PD (progressive disease) or death is first reported, assessed up to 2 years

  4. 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).

    Measured: From the date of registration to the date of death, assessed up to 2 years

  5. 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).

    Measured: From the time that measurement criteria are first met for CR until the date that PD is objectively documented, assessed up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Oct 2013 (estimated)
  2. Study startAug 2014
  3. Primary completion9 Oct 2017
  4. Study completion11 Nov 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01958372
Sponsor's protocol ID
2013-021
Other IDs
NCI-2013-01835, 1307012220, 2013-021, P30CA022453
Status last verified
Nov 2020
First submitted
7 Oct 2013
Last updated
23 Nov 2020
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing soy isoflavones, cisplatin and etoposide in people with Adenocarcinoma of the Lung and Adenosquamous Cell Lung Cancer, run by Barbara Ann Karmanos Cancer Institute at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 25 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01958372.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2020.

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