Clinical trial NCT01473563: A Study of Home Administration of Pemetrexed as Maintenance Treatment for Advanced Nonsquamous Non-Small Cell Lung Cancer (NSCLC)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Nonsquamous Non-Small Cell Neoplasm of Lung
Non-Small Cell Lung Cancer Metastatic
Non-Small Cell Lung Cancer Stage IIIB
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2011-11-17
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: 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 the participant's quality of life?
* What are the required medical resources needed to give pemetrexed in a home setting?


Eligibility criteria: Inclusion Criteria:

* Have a histological or cytological diagnosis of 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 \[see Response Evaluation Criteria in Solid Tumors (RECIST), version (v) 1.1\]
* 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 (in other words, 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/Liter (L), platelets \>=100x109/L, and hemoglobin \>=9 grams per deciliter (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 milliliters per minute (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

Primary outcomes:
measure: Percentage of Participants Who Adhered to Treatment Administration at Home
timeFrame: Cycle 1, Day 1 through Cycle 19, Day 1 and Cycle 19, Day 1 (21 days/cycle)
Secondary outcomes:
measure: Change From Baseline in the European Quality of Life Instrument (EQ-5D) Visual Analogue Scale (VAS)
timeFrame: Baseline, Day 1 of Cycles 2 and 4 (21 days/cycle) and 30 days post treatment discontinuation
measure: Change From Baseline in the EQ-5D Index Score
timeFrame: Baseline, Day 1 of Cycles 2 and 4 (21 days/cycle) and 30 days post treatment discontinuation
measure: Maximum Improvement Over Baseline in Individual Lung Cancer Symptoms Scale (LCSS) Item Scores
timeFrame: Baseline, Day 1 of each cycle (up to Cycle 19, 21 days/cycle), and 30 days post treatment discontinuation
measure: Participant Satisfaction: Chemotherapy at Hospital
timeFrame: The first evaluation completed at either Cycle 4, Day 1 (21 days/cycle) or 30 days post treatment discontinuation
measure: Participant Satisfaction: Chemotherapy at Home
timeFrame: The first evaluation completed at either Cycle 4, Day 1 (21 days/cycle) or 30 days post treatment discontinuation
measure: Participant Satisfaction: Regarding the Study Nurse
timeFrame: The first evaluation completed at either Cycle 4, Day 1 (21 days/cycle) or 30 days post treatment discontinuation
measure: Participant Satisfaction: Preferences Regarding Home and/or Hospital Treatment
timeFrame: The first evaluation completed at either Cycle 4, Day 1 (21 days/cycle) or 30 days post treatment discontinuation
measure: Physician Satisfaction: Distant Management of Participant
timeFrame: 30 days post treatment discontinuation
measure: Resource Utilization: Number of Participants With an Unplanned Use of Healthcare Resources
timeFrame: Cycle 1, Day 1 through last day of cycle when participant reverted to hospital administration or discontinued (up to Cycle 19, 21 days/cycle)
measure: Resource Utilization: Unplanned Health Care Visits, Consultations, and Diagnostic Services
timeFrame: Cycle 1, Day 1 through last day of cycle when participant reverted to hospital administration or discontinued (up to Cycle 19, 21 days/cycle)
measure: Resource Utilization: Duration of Health Care Visits
timeFrame: Cycle 2, Day 1 through last day of cycle when participant reverted to hospital administration or discontinued (up to Cycle 4, 21 days/cycle)
measure: Resource Utilization: Distances Traveled
timeFrame: Cycle 1, Day 1 through last day of cycle when participant reverted to hospital administration or discontinued (up to Cycle 4, 21 days/cycle)
measure: Overall Survival (OS) at 6 Months
timeFrame: Cycle 1, Day 1 to the date of death from any cause (up to Month 6)
measure: Time to Treatment Failure (TTF)
timeFrame: Cycle 1, Day 1 to first event (up to Cycle 19, 21 days/cycle)
Other outcomes:
measure: Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), or Died
timeFrame: First dose of study drug (Cycle 1, Day 1) through study completion [up to Cycle 19 (21 days/cycle) or treatment discontinuation, plus up to 6 months post treatment discontinuation]
Locations:
city: Linkoping
country: Sweden
facility: 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.
city: Solna
country: Sweden
facility: 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.
city: London
country: United Kingdom
facility: 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.
state: Greater London
city: Maidstone
country: United Kingdom
facility: 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.
state: Kent
city: Nottingham
country: United Kingdom
facility: 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.
state: Nottinghamshire
city: Aberdeen
country: United Kingdom
facility: 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.
state: Scotland
city: Huddersfield
country: United Kingdom
facility: 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.
state: West Yorkshire
city: Birmingham
country: United Kingdom
facility: 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.
city: Manchester
country: United Kingdom
facility: 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.
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References:
citation: Lal R, Bourayou N, Hillerdal G, Nicolson M, Vikstrom A, Lorenzo M, D'yachkova Y, Barriga S, Visseren-Grul C. Home administration of maintenance pemetrexed for patients with advanced non-squamous non-small cell lung cancer: rationale, practicalities and phase II feasibility study design. Health Qual Life Outcomes. 2013 Oct 3;11:163. doi: 10.1186/1477-7525-11-163.