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

Non-Small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00732303
• Other study ID #: LUN08-129
• Status: Terminated
• Phase: Phase 2
• First received: August 7, 2008
• Last updated: August 17, 2015
• Start date: August 2008
• Est. completion date: December 2010

Study information

• Verified date: August 2015
• Source: Hoosier Cancer Research Network
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer

Intervention

Drug:
• Pemetrexed
Pemetrexed (Alimta) 500mg/m2 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.

Locations

Country	Name	City	State
United States	Cancer Care Center of Southern Indiana	Bloomington	Indiana
United States	Northwestern University Feinberg School of Medicine	Chicago	Illinois
United States	NorthShore University Health System - Kellogg Cancer Center	Evanston	Illinois
United States	Fort Wayne Oncology & Hematology, Inc	Fort Wayne	Indiana
United States	Medical & Surgical Specialists, LLC	Galesburg	Illinois
United States	Community Regional Cancer Center	Indianapolis	Indiana
United States	IN Onc/Hem Associates	Indianapolis	Indiana
United States	Indiana University Simon Cancer Center	Indianapolis	Indiana
United States	Horizon Oncology Center	Lafayette	Indiana
United States	Hematology Oncology Associates S.J., P.A.	Mt. Holly	New Jersey
United States	Medical Consultants, P.C.	Muncie	Indiana
United States	Monroe Medical Associates	Munster	Indiana
United States	Pennsylvania Oncology-Hematology Associates	Philadelphia	Pennsylvania
United States	Providence Portland Medical Center	Portland	Oregon
United States	Fox Chase Cancer Center Extramural Research Program	Rockledge	Pennsylvania
United States	Northern Indiana Cancer Research Consortium	South Bend	Indiana
United States	Siteman Cancer Center	St. Louis	Missouri
United States	Providence Medical Group	Terre Haute	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Hoosier Cancer Research Network	Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	- To determine progression free survival in patients with poor risk stage III NSCLC treated with pemetrexed and concurrent definitive radiation		24 months	No
Secondary	- To determine the toxicities of pemetrexed and concurrent definitive radiation in patients with poor risk stage III NSCLC.		24 months	Yes
Secondary	- To determine overall survival of pemetrexed and concurrent definitive radiation in patients with poor risk stage III NSCLC.		24 months	No