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

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ClinicalTrials.gov Identifier: NCT00732303
Recruitment Status : Terminated (Study terminated due to withdrawal of pharmaceutical funding)
First Posted : August 11, 2008
Results First Posted : April 27, 2016
Last Update Posted : April 27, 2016
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Hoosier Cancer Research Network

Study Description
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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.

Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer Drug: Pemetrexed Radiation: Radiation Therapy Phase 2

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
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : January 2009
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.

 Drug: Pemetrexed
Pemetrexed (Alimta) 500mg/^2 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.


Outcome Measures
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Primary Outcome Measures :
  1. Progression Free Survival [ Time Frame: 24 months ]
    To determine progression free survival in patients with poor risk stage III NSCLC treated with pemetrexed and concurrent definitive radiation


Secondary Outcome Measures :
  1. Assess Safety and Toxicity [ Time Frame: 24 months ]
    - To determine the toxicities of pemetrexed and concurrent definitive radiation in patients with poor risk stage III NSCLC.

  2. Overall Survival [ Time Frame: 24 months ]
    To determine overall survival of pemetrexed and concurrent definitive radiation in patients with poor risk stage III NSCLC.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00732303


Locations
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Sponsors and Collaborators
Hoosier Cancer Research Network
Eli Lilly and Company
Investigators
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Study Chair: Nasser Hanna, M.D. Hoosier Cancer Research Network
More Information
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Responsible Party: Hoosier Cancer Research Network
ClinicalTrials.gov Identifier: NCT00732303    
Other Study ID Numbers: LUN08-129
First Posted: August 11, 2008    Key Record Dates
Results First Posted: April 27, 2016
Last Update Posted: April 27, 2016
Last Verified: March 2016
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
 Carcinoma, Bronchogenic
Bronchial Neoplasms
Pemetrexed
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors