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

NCT ID: NCT00732303

Last Updated: 2016-04-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2010-12-31

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.

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

Conditions

Non-Small Cell Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Pemetrexed

Intervention Type: DRUG

Pemetrexed (Alimta) 500mg/\^2 administered intravenously over approximately 10-minutes on Day 1 of a 21-day cycle x 3 cycles

Radiation Therapy

Intervention Type: RADIATION

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.

Interventions

Pemetrexed

Pemetrexed (Alimta) 500mg/\^2 administered intravenously over approximately 10-minutes on Day 1 of a 21-day cycle x 3 cycles

Intervention Type: DRUG

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.

Intervention Type: RADIATION

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: collaborator

Hoosier Cancer Research Network

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nasser Hanna, M.D.

Role: STUDY_CHAIR

Hoosier Cancer Research Network

Locations

Northwestern University Feinberg School of Medicine

Chicago, Illinois, United States

NorthShore University Health System - Kellogg Cancer Center

Evanston, Illinois, United States

Medical & Surgical Specialists, LLC

Galesburg, Illinois, United States

Cancer Care Center of Southern Indiana

Bloomington, Indiana, United States

Fort Wayne Oncology & Hematology, Inc

Fort Wayne, Indiana, United States

IN Onc/Hem Associates

Indianapolis, Indiana, United States

Indiana University Simon Cancer Center

Indianapolis, Indiana, United States

Community Regional Cancer Center

Indianapolis, Indiana, United States

Horizon Oncology Center

Lafayette, Indiana, United States

Medical Consultants, P.C.

Muncie, Indiana, United States

Monroe Medical Associates

Munster, Indiana, United States

Northern Indiana Cancer Research Consortium

South Bend, Indiana, United States

Providence Medical Group

Terre Haute, Indiana, United States

Siteman Cancer Center

St Louis, Missouri, United States

Hematology Oncology Associates S.J., P.A.

Mount Holly, New Jersey, United States

Providence Portland Medical Center

Portland, Oregon, United States

Pennsylvania Oncology-Hematology Associates

Philadelphia, Pennsylvania, United States

Fox Chase Cancer Center Extramural Research Program

Rockledge, Pennsylvania, United States

Countries

United States

Other Identifiers

LUN08-129

Identifier Type: -

Identifier Source: org_study_id