Pemetrexed and Radiation for Poor-Risk Stage III Non-Small Cell Lung Cancer

Study summary

Pemetrexed is approved for second line therapy in metastatic NSCLC. Given the single-agent activity of pemetrexed and the tolerability of pemetrexed in combination with radiation, this study will evaluate survival rates and toxicities in patients with poor risk stage III NSCLC.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedPemetrexed and Radiation Therapy

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · Locally advanced · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Apr 27, 2016 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?18 U.S. locations

Locations may change over time.

Who runs it?Hoosier Cancer Research Network

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 2
Sponsor: Hoosier Cancer Research Network
Interventions being studied: Drug: Pemetrexed; Radiation: Radiation Therapy

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Non-small cell lung cancer (NSCLC)→

Disease setting

Locally advanced→Metastatic or stage IV→

Treatment approach

Chemotherapy→Radiation therapy→

Study topics

After prior treatment→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

Histological or cytological proof of Non Small Cell Lung Cancer (NSCLC)
Measurable or non-measurable disease per RECIST as evaluated by imaging within 28 days prior to registration for protocol therapy
Unresectable Stage IIIA or IIIB disease as evaluated by imaging within 28 days prior to registration for protocol therapy
Weight loss of greater than 10% in the preceding six months prior to registration for protocol therapy.
Serum albumin \< 0.85 x institutional lower limit of normal
Able and willing to interrupt non-steroidal anti-inflammatory agents for 2 days before (5 days for long acting agents such as piroxicam), the day of, and 2 days following administration of pemetrexed
Lung V20 \< 35% within 14 days prior to registration for protocol therapy, as planned by the radiation oncologist
Mean lung dose \< 20 Gy within 14 days prior to registration for protocol therapy, as planned by the radiation oncologist
Written informed consent and HIPAA authorization for release of personal health information
Age ≥ 18 years
Females of childbearing potential and males must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) from the time of consent until at least 90 days following completion of study treatment.
Females of childbearing potential must have a negative pregnancy test within 7 days prior to registration for protocol therapy. Patients are considered not of child bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal.

Reasons someone may not be able to joinExclusion criteria

Patients with malignant pleural effusions are not eligible. The only exception is a patient with a pleural effusion visible only on CT scan (and not visible on CXR) OR deemed too small to tap.
No CNS metastases. All patients must undergo a CT scan/MRI of the brain within 28 days prior to registration for protocol therapy to exclude brain metastasis.
No prior chemotherapy, adjuvant therapy or radiotherapy for lung cancer.
No metastatic disease as determined by PET scan within 28 days prior to registration for protocol therapy.
No active clinically serious infections as judged by the treating investigator (\> CTC v3, Grade 2) including known human immunodeficiency virus (HIV) infection or chronic Hepatitis B or C.
No other active malignancies.
No history of collagen vascular disease (CVD).
No significant history of cardiac disease. Must not have unstable angina (anginal symptoms at rest).
No history of psychiatric illness/social situations that would limit compliance with study requirements.
Females must not be breastfeeding.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Northwestern University Feinberg School of MedicineChicago, Illinois
NorthShore University Health System - Kellogg Cancer CenterEvanston, Illinois
Medical & Surgical Specialists, LLCGalesburg, Illinois
Cancer Care Center of Southern IndianaBloomington, Indiana
Fort Wayne Oncology & Hematology, IncFort Wayne, Indiana
IN Onc/Hem AssociatesIndianapolis, Indiana
Indiana University Simon Cancer CenterIndianapolis, Indiana
Community Regional Cancer CenterIndianapolis, Indiana
Horizon Oncology CenterLafayette, Indiana
Medical Consultants, P.C.Muncie, Indiana
Monroe Medical AssociatesMunster, Indiana
Northern Indiana Cancer Research ConsortiumSouth Bend, Indiana

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Apr 27, 2016. Always confirm current availability with the study team.

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