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

NCT00732303 | Terminated Phase 2 Results DMC

• 1 other identifier: LUN08-129
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 18

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.

Conditions

Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival

  To determine progression free survival in patients with poor risk stage III NSCLC treated with pemetrexed and concurrent definitive radiation

  24 months

Secondary Outcomes (2)

• Assess Safety and Toxicity

  24 months

• Overall Survival

  24 months

Study Arms (1)

1

EXPERIMENTAL

* 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; Radiation: Radiation Therapy

Interventions

Pemetrexed DRUG

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

1

Radiation Therapy 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.

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hoosier Cancer Research Network: lead
• Eli Lilly and Company: collaborator

Study Sites (18)

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

NorthShore University Health System - Kellogg Cancer Center

Evanston, Illinois, 60201, United States

Location

Medical & Surgical Specialists, LLC

Galesburg, Illinois, 61401, United States

Location

Cancer Care Center of Southern Indiana

Bloomington, Indiana, 47403, United States

Location

Fort Wayne Oncology & Hematology, Inc

Fort Wayne, Indiana, 46815, United States

Location

IN Onc/Hem Associates

Indianapolis, Indiana, 46202, United States

Location

Indiana University Simon Cancer Center

Indianapolis, Indiana, 46202, United States

Location

Community Regional Cancer Center

Indianapolis, Indiana, 46256, United States

Location

Horizon Oncology Center

Lafayette, Indiana, 47905, United States

Location

Medical Consultants, P.C.

Muncie, Indiana, 47303, United States

Location

Monroe Medical Associates

Munster, Indiana, 46321, United States

Location

Northern Indiana Cancer Research Consortium

South Bend, Indiana, 46601, United States

Location

Providence Medical Group

Terre Haute, Indiana, 47802, United States

Location

Siteman Cancer Center

St Louis, Missouri, 63110, United States

Location

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

Mount Holly, New Jersey, 08060, United States

Location

Providence Portland Medical Center

Portland, Oregon, 97213, United States

Location

Pennsylvania Oncology-Hematology Associates

Philadelphia, Pennsylvania, 19106, United States

Location

Fox Chase Cancer Center Extramural Research Program

Rockledge, Pennsylvania, 19046, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Pemetrexed; Radiotherapy

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Therapeutics

Results Point of Contact

• Title: Clinical Data Coordinator
• Organization: Hoosier Cancer Research Network, Inc.

jsmith@hoosiercancer.org

317-921-2050

Study Officials

• Nasser Hanna, M.D.

  Hoosier Cancer Research Network

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2008
• First Posted: August 11, 2008
• Study Start: January 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: April 27, 2016
• Results First Posted: April 27, 2016

Record last verified: 2016-03

Locations

US (18)