A Study of Home Administration of Pemetrexed as Maintenance Treatment for Advanced Nonsquamous Non-Small Cell Lung Cancer (NSCLC)

NCT01473563 | Completed Phase 2 Results

• 2 other identifiers: 14079H3E-EW-S133
• Study Type: interventional
• Target: 52
• Locations: 2 countries
• Sites: 9

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?

Conditions

Nonsquamous Non-Small Cell Neoplasm of Lung; Non-Small Cell Lung Cancer Metastatic; Non-Small Cell Lung Cancer Stage IIIB

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Who Adhered to Treatment Administration at Home

  Participants were considered adherent from the time of the first dose in Cycle 1 (hospital administration) until either the last day of the cycle when the participant reverted to pemetrexed hospital administration or the last day of the cycle when the participant discontinued study treatment or the study for reasons related to the home setting. The percentage of participants who adhered to treatment administration at home was estimated by a Kaplan-Meier survival analyses approach. Participants who died or discontinued the study and treatment without reverting to hospital administration were censored at the time of discontinuation.

  Cycle 1, Day 1 through Cycle 19, Day 1 and Cycle 19, Day 1 (21 days/cycle)

Secondary Outcomes (14)

• Change From Baseline in the European Quality of Life Instrument (EQ-5D) Visual Analogue Scale (VAS)

  Baseline, Day 1 of Cycles 2 and 4 (21 days/cycle) and 30 days post treatment discontinuation

• Change From Baseline in the EQ-5D Index Score

  Baseline, Day 1 of Cycles 2 and 4 (21 days/cycle) and 30 days post treatment discontinuation

• Maximum Improvement Over Baseline in Individual Lung Cancer Symptoms Scale (LCSS) Item Scores

  Baseline, Day 1 of each cycle (up to Cycle 19, 21 days/cycle), and 30 days post treatment discontinuation

• Participant Satisfaction: Chemotherapy at Hospital

  The first evaluation completed at either Cycle 4, Day 1 (21 days/cycle) or 30 days post treatment discontinuation

• Participant Satisfaction: Chemotherapy at Home

  The first evaluation completed at either Cycle 4, Day 1 (21 days/cycle) or 30 days post treatment discontinuation

Other Outcomes (1)

• Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), or Died

  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]

Study Arms (1)

Pemetrexed

EXPERIMENTAL

500 milligrams per square meter (mg/m\^2) pemetrexed administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle. Maintenance therapy administered 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

Interventions

Pemetrexed DRUG

Administered intravenously

Also known as: LY231514, Alimta, Pemetrexed disodium, Pemetrexed sodium hydrate

Pemetrexed

Eligibility Criteria

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

You may qualify if:

• 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:

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (9)

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.

Linköping, 58185, Sweden

Location

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, 17176, Sweden

Location

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, Birmingham, B95SS, United Kingdom

Location

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, SE1 9RT, United Kingdom

Location

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, ME16 9QQ, United Kingdom

Location

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, NG5 1PD, United Kingdom

Location

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, AB25 2ZN, United Kingdom

Location

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, United Kingdom

Location

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, HD3 3EA, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 24090033 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Pemetrexed

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

Limitations and Caveats

A thorough literature search revealed that no specific validated questionnaire was available to assess participant and physician satisfaction with home care or resource utilization, therefore specific questions were created by the sponsor for use.

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

800-545-5979

Study Officials

• 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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: November 2, 2011
• First Posted: November 17, 2011
• Study Start: December 1, 2011
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: October 6, 2014
• Results First Posted: October 6, 2014

Record last verified: 2014-10

Locations

SE (2); GB (7)