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

This study has been terminated.
(Study terminated due to slow accrual)
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by:
Hoosier Cancer Research Network
ClinicalTrials.gov Identifier:
NCT00732303
First received: August 7, 2008
Last updated: April 28, 2011
Last verified: April 2011
  Purpose

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 Intervention Phase
Non-Small Cell Lung Cancer
Drug: Pemetrexed
Radiation: Radiation Therapy
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Hoosier Cancer Research Network:

Primary Outcome Measures:
  • - To determine progression free survival in patients with poor risk stage III NSCLC treated with pemetrexed and concurrent definitive radiation [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • - To determine the toxicities of pemetrexed and concurrent definitive radiation in patients with poor risk stage III NSCLC. [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • - To determine overall survival of pemetrexed and concurrent definitive radiation in patients with poor risk stage III NSCLC. [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Enrollment: 8
Study Start Date: August 2008
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
  • 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.

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.


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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00732303

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
Community Regional Cancer Center
Indianapolis, Indiana, United States, 46256
IN Onc/Hem Associates
Indianapolis, Indiana, United States, 46202
Indiana University Simon Cancer Center
Indianapolis, Indiana, United States, 46202
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

No publications provided

Responsible Party: Nasser Hanna, M.D., Hoosier Oncology Group
ClinicalTrials.gov Identifier: NCT00732303     History of Changes
Other Study ID Numbers: LUN08-129
Study First Received: August 7, 2008
Last Updated: April 28, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Pemetrexed
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014