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

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief 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.

Condition or disease	Intervention/treatment	Phase
Non-Small Cell Lung Cancer	Drug: Pemetrexed; Radiation: Radiation Therapy	Phase 2

Detailed Description:

OUTLINE: This is a multi-center study.

• Pemetrexed (Alimta) 500mg/m2 administered intravenously over approximately 10-minutes on Day 1 of a 21-day cycle x 3 cycles
• Radiation will start between days -1 to 2 from day 1 of cycle 1. Day 1 radiotherapy must be a Monday, Tuesday, or Wednesday.

The planned radiation dose is 60 Gy in 2.0 Gy fractions. The entire PTV, including primary tumor and areas of known nodal disease, shall receive 60 Gy at 2.0 Gy fractions, 5 fractions/week for 30 fractions over 6 weeks.

Performance Status: ECOG performance status 2

Life Expectancy: Not specified

Hematopoietic:

• Platelets ≥ 100 K/mm3
• Absolute Neutrophil Count (ANC) ≥ 2.0 K/mm3

Hepatic:

• Aspartate transaminase (AST) ≤ 2.5 x ULN.
• Alanine transaminase (ALT) ≤ 2.5 x ULN.
• Total bilirubin ≤ 1.5 x ULN

Renal:

• Calculated creatinine clearance (using Cockcroft-Gault formula) ≥ 45 cc/min

Cardiovascular:

• No significant history of cardiac disease. Must not have unstable angina (anginal symptoms at rest).

Pulmonary:

• Forced expiratory volume in 1 second (FEV1) greater than 1L

Study Design

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	8 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	A Phase II Study of Concurrent Pemetrexed and Radiation for Poor-Risk Stage III Non-Small Cell Lung Cancer: Hoosier Oncology Group LUN08-129
Study Start Date :	January 2009
Actual Primary Completion Date :	December 2010
Actual Study Completion Date :	December 2010

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm

Intervention/treatment

Experimental: 1; Pemetrexed (Alimta) 500mg/m^2 administered intravenously over approximately 10-minutes on Day 1 of a 21-day cycle x 3 cycles; Radiation will start between days -1 to 2 from day 1 of cycle 1. Day 1 radiotherapy must be a Monday, Tuesday, or Wednesday. The planned radiation dose is 60 Gy in 2.0 Gy fractions. The entire PTV, including primary tumor and areas of known nodal disease, shall receive 60 Gy at 2.0 Gy fractions, 5 fractions/week for 30 fractions over 6 weeks.

Drug: Pemetrexed; Pemetrexed (Alimta) 500mg/^2 administered intravenously over approximately 10-minutes on Day 1 of a 21-day cycle x 3 cycles Radiation: Radiation Therapy; Radiation will start between days -1 to 2 from day 1 of cycle 1. Day 1 radiotherapy must be a Monday, Tuesday, or Wednesday. The planned radiation dose is 60 Gy in 2.0 Gy fractions. The entire PTV, including primary tumor and areas of known nodal disease, shall receive 60 Gy at 2.0 Gy fractions, 5 fractions/week for 30 fractions over 6 weeks.

Outcome Measures

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Progression Free Survival [ Time Frame: 24 months ]
   To determine progression free survival in patients with poor risk stage III NSCLC treated with pemetrexed and concurrent definitive radiation

Secondary Outcome Measures :

1. Assess Safety and Toxicity [ Time Frame: 24 months ]
   - To determine the toxicities of pemetrexed and concurrent definitive radiation in patients with poor risk stage III NSCLC.
2. Overall Survival [ Time Frame: 24 months ]
   To determine overall survival of pemetrexed and concurrent definitive radiation in patients with poor risk stage III NSCLC.

Eligibility Criteria

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion 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.

Exclusion 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.

Contacts and Locations

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Illinois
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States, 60611
NorthShore University Health System - Kellogg Cancer Center
Evanston, Illinois, United States, 60201
Medical & Surgical Specialists, LLC
Galesburg, Illinois, United States, 61401
United States, Indiana
Cancer Care Center of Southern Indiana
Bloomington, Indiana, United States, 47403
Fort Wayne Oncology & Hematology, Inc
Fort Wayne, Indiana, United States, 46815
IN Onc/Hem Associates
Indianapolis, Indiana, United States, 46202
Indiana University Simon Cancer Center
Indianapolis, Indiana, United States, 46202
Community Regional Cancer Center
Indianapolis, Indiana, United States, 46256
Horizon Oncology Center
Lafayette, Indiana, United States, 47905
Medical Consultants, P.C.
Muncie, Indiana, United States, 47303
Monroe Medical Associates
Munster, Indiana, United States, 46321
Northern Indiana Cancer Research Consortium
South Bend, Indiana, United States, 46601
Providence Medical Group
Terre Haute, Indiana, United States, 47802
United States, Missouri
Siteman Cancer Center
St. Louis, Missouri, United States, 63110
United States, New Jersey
Hematology Oncology Associates S.J., P.A.
Mt. Holly, New Jersey, United States, 08060
United States, Oregon
Providence Portland Medical Center
Portland, Oregon, United States, 97213
United States, Pennsylvania
Pennsylvania Oncology-Hematology Associates
Philadelphia, Pennsylvania, United States, 19106
Fox Chase Cancer Center Extramural Research Program
Rockledge, Pennsylvania, United States, 19046

Sponsors and Collaborators

Hoosier Cancer Research Network

Eli Lilly and Company

Investigators

Study Chair:	Nasser Hanna, M.D.	Hoosier Cancer Research Network

More Information

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Hoosier Cancer Research Network
ClinicalTrials.gov Identifier:	NCT00732303 History of Changes
Other Study ID Numbers:	LUN08-129
First Posted:	August 11, 2008
Results First Posted:	April 27, 2016
Last Update Posted:	April 27, 2016
Last Verified:	March 2016

Additional relevant MeSH terms:

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases	Carcinoma, Bronchogenic; Bronchial Neoplasms; Pemetrexed; Antineoplastic Agents; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Folic Acid Antagonists; Nucleic Acid Synthesis Inhibitors