A Study of Home Administration of Pemetrexed as Maintenance Treatment for Advanced Nonsquamous Nonsmall Cell Lung Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01473563
First received: November 2, 2011
Last updated: October 9, 2013
Last verified: October 2013
  Purpose

The main purpose for this study is to answer the following research questions:

  • Can pemetrexed be administered safely at the participant's home, using the same treatment procedure as in a hospital setting?
  • Will the participant be satisfied with home care?
  • How might this impact on the participant's quality of life?
  • What are the required medical resources needed to give pemetrexed in a home setting?

Condition Intervention Phase
Nonsquamous Nonsmall Cell Neoplasm of Lung
Non-small Cell Lung Cancer Metastatic
Non-small Cell Lung Cancer Stage IIIB
Drug: Pemetrexed
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Home Delivery of Pemetrexed as Maintenance Treatment in Patients Who Have Not Progressed After Induction Therapy for Advanced Nonsquamous Nonsmall Cell Lung Cancer: A Feasibility Study

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Proportion of participants who adhere to treatment administration at home [ Time Frame: Day 1 of Cycle 1 to date participant reverts to infusions in the hospital or discontinues due to the home setting (estimated at 9 months) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Resource utilization: Number of participants with unplanned use of healthcare resources [ Time Frame: Day 1 of Cycle 1 to date discontinuation criteria are met (estimated at 9 months) ] [ Designated as safety issue: No ]
  • Resource utilization: Duration of health care visits [ Time Frame: Day 1 of Cycle 1 to date discontinuation criteria are met (estimated at 9 months) ] [ Designated as safety issue: No ]
  • Satisfaction with home care [ Time Frame: Day 1 of Cycle 4 and 30 days post-discontinuation ] [ Designated as safety issue: No ]
  • Time to treatment failure (TTF) [ Time Frame: Day 1 of Cycle 1 to first event (estimated at 9 months) ] [ Designated as safety issue: Yes ]
  • Overall survival (OS) [ Time Frame: Day 1 of Cycle 1 to the date of death from any cause (estimated at 15 months) ] [ Designated as safety issue: Yes ]
  • Resource utilization: Distances traveled [ Time Frame: Day 1 of Cycle 1 to date discontinuation criteria are met (estimated at 9 months) ] [ Designated as safety issue: No ]
  • Change From Baseline in the EuroQol Instrument (EQ-5D) Index Score [ Time Frame: Baseline, Day 1 of each cycle, 30 days post-discontinuation ] [ Designated as safety issue: No ]
  • Resource utilization: Number of unplanned health care visits, consultation and diagnosis services [ Time Frame: Day 1 of Cycle 1 to date discontinuation criteria are met (estimated at 9 months) ] [ Designated as safety issue: No ]
  • Change From Baseline in EuroQol Instrument (EQ-5D) Visual Analog Scale (VAS) [ Time Frame: Baseline, Day 1 of each cycle, 30 days post-discontinuation ] [ Designated as safety issue: No ]
  • Changes in individual symptom scores and quality of life using the Lung Cancer Symptoms Scale (LCSS) [ Time Frame: Baseline, Day 1 of each cycle, 30 days post-discontinuation ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: December 2011
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pemetrexed
500 mg/m^2 pemetrexed administered intravenously on Day 1 of a 21-day cycle in 10 minutes as maintenance therapy until disease progression or the participant is discontinued for any other reason. The first dose of maintenance therapy will be administered at the hospital; thereafter, therapy will be administered in the home setting by qualified oncology homecare nurses.
Drug: Pemetrexed
Administered intravenously
Other Names:
  • LY231514
  • Alimta
  • Pemetrexed disodium
  • Pemetrexed sodium hydrate

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have a histological or cytological diagnosis of Nonsmall Cell Lung Cancer (NSCLC) defined as nonsquamous cell histology. Squamous cell and/or small cell histology is not permitted. Mixed NSCLC tumors will be categorized by the predominant cell type. NSCLC tumors that are not otherwise specified with regard to histology or cannot be subclassified as squamous, adenocarcinoma, or large cell histology will be categorized as nonsquamous
  • Have Stage IIIB (not amenable to curative treatment) or Stage IV NSCLC prior to induction therapy as defined by the American Joint Committee on Cancer (AJCC) Staging Criteria for Lung Cancer
  • Have completed 4 induction cycles of platinum-based doublet therapy (type at the discretion of the physician) for treatment of their advanced disease.
  • Have not progressed after 4 cycles of induction therapy. Documented radiographic evidence of a tumor response must occur at the end of Cycle 4 of induction therapy within 3 weeks before receiving the first cycle of study drug (see Response Evaluation Criteria in Solid Tumors [RECIST] version 1.1)
  • Receive on-study treatment no earlier than 21 days and no later than 42 days from Cycle 4 Day 1 of induction therapy
  • Have a Performance Status (PS) of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale
  • Meet the following guidelines if the participant has received prior radiation therapy:

    • Previous radiation therapy is allowed to <25% of the bone marrow, but should have been limited and must not have included whole pelvis radiation
    • Participants must have recovered from the toxic effects of the treatment prior to study enrollment (except for alopecia)
    • Participants who received palliative chest (i.e. thoracic skeleton including dorsal spine) or palliative extrathoracic radiotherapy to preexisting lesions are allowed to be enrolled in this trial
  • Have adequate organ function, including:

    • Adequate bone marrow reserve: absolute neutrophil count (ANC) (segmented and bands) >=1.5x109/L, platelets >=100x109/L, and hemoglobin >=9 g/dL
    • Hepatic: bilirubin <=1.5 x upper limit of normal (ULN) and alkaline phosphatase (ALP), aspartate aminotransferase (AST), and alanine aminotransferase (ALT) <=3.0 x ULN (ALP, AST, and ALT <=5.0 x ULN are acceptable if the liver has tumor involvement
    • Renal: calculated creatinine clearance (CrCl) >=45 mL/min based on the original weight-based Cockcroft and Gault formula
  • Are willing to comply with the following contraceptive criteria:

    • Females must be surgically sterile, postmenopausal or must have a negative serum or urine pregnancy test within 7 days prior to the first dose of study drug
    • Males and females with reproductive potential: Must agree to use a reliable method of birth control during the study and for 6 months following the last dose of study drug
  • Have an estimated life expectancy of at least 12 weeks
  • Have given written informed consent/assent prior to any study-specific procedures
  • Are willing to comply with home delivery administration and have family or close environment support willing to comply with home delivery administration

Exclusion Criteria:

  • Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational product or no approved use of a drug or device (other than pemetrexed used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
  • Have previously completed or withdrawn from this study
  • Have a serious concomitant systemic disorder (for example, active infection including human immunodeficiency virus)
  • Have a serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease, as defined by the New York Heart Association Class III or IV
  • Have symptomatic central nervous system (CNS) malignancy or metastasis (screening not required). Participants with treated CNS metastases are eligible for this study if they are not currently receiving corticosteroids and/or anticonvulsants for at least 1 week before starting study treatment and their disease is asymptomatic and radiographically stable
  • Are receiving concurrent administration of any other antitumor therapy
  • Have a second primary malignancy that in the judgment of the investigator and sponsor may affect the interpretation of results
  • Are unable to interrupt aspirin or other nonsteroidal anti-inflammatory agents, other than aspirin dose ≤1.3 grams per day, for a 5-day period (8-day period for long-acting agents, such as piroxicam)
  • Are unable or unwilling to take folic acid or vitamin B12 supplementation
  • Are unable or unwilling to take corticosteroids
  • Are pregnant or lactating
  • Have received a recent (within 30 days of enrollment) or are receiving concurrent yellow fever vaccination
  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: NCT01473563

Locations
Sweden
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Linkoping, Sweden, 58185
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Solna, Sweden, 17176
United Kingdom
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
London, Greater London, United Kingdom, SE1 9RT
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Maidstone, Kent, United Kingdom, ME16 9QQ
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Nottingham, Nottinghamshire, United Kingdom, NG5 1PD
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Aberdeen, Scotland, United Kingdom, AB25 2ZN
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Huddersfield, West Yorkshire, United Kingdom, HD3 3EA
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Birmingham, United Kingdom, B95SS
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Manchester, United Kingdom, M20 4BX
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  More Information

No publications provided by Eli Lilly and Company

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01473563     History of Changes
Other Study ID Numbers: 14079, H3E-EW-S133
Study First Received: November 2, 2011
Last Updated: October 9, 2013
Health Authority: Sweden: Medical Products Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
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
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Folic Acid Antagonists

ClinicalTrials.gov processed this record on September 18, 2014