Clinical trial NCT00732303: Pemetrexed and Radiation for Poor-Risk Stage III Non-Small Cell Lung Cancer
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Non-Small Cell Lung Cancer
Lead sponsor: Hoosier Cancer Research Network
Sponsor class: OTHER
Collaborators: name: Eli Lilly and Company
First posted: 2008-08-11
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Progression Free Survival
timeFrame: 24 months
Secondary outcomes:
measure: Assess Safety and Toxicity
timeFrame: 24 months
measure: Overall Survival
timeFrame: 24 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine
state: Illinois
city: Evanston
country: United States
facility: NorthShore University Health System - Kellogg Cancer Center
state: Illinois
city: Galesburg
country: United States
facility: Medical & Surgical Specialists, LLC
state: Illinois
city: Bloomington
country: United States
facility: Cancer Care Center of Southern Indiana
state: Indiana
city: Fort Wayne
country: United States
facility: Fort Wayne Oncology & Hematology, Inc
state: Indiana
city: Indianapolis
country: United States
facility: IN Onc/Hem Associates
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University Simon Cancer Center
state: Indiana
city: Indianapolis
country: United States
facility: Community Regional Cancer Center
state: Indiana
city: Lafayette
country: United States
facility: Horizon Oncology Center
state: Indiana
city: Muncie
country: United States
facility: Medical Consultants, P.C.
state: Indiana
city: Munster
country: United States
facility: Monroe Medical Associates
state: Indiana
city: South Bend
country: United States
facility: Northern Indiana Cancer Research Consortium
state: Indiana
city: Terre Haute
country: United States
facility: Providence Medical Group
state: Indiana
city: St. Louis
country: United States
facility: Siteman Cancer Center
state: Missouri
city: Mt. Holly
country: United States
facility: Hematology Oncology Associates S.J., P.A.
state: New Jersey
city: Portland
country: United States
facility: Providence Portland Medical Center
state: Oregon
city: Philadelphia
country: United States
facility: Pennsylvania Oncology-Hematology Associates
state: Pennsylvania
city: Rockledge
country: United States
facility: Fox Chase Cancer Center Extramural Research Program
state: Pennsylvania
Study officials:
affiliation: Hoosier Cancer Research Network
name: Nasser Hanna, M.D.
role: STUDY_CHAIR
References: