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

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 3, 2014
Last verified: October 2014
Results First Received: June 12, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label
Conditions: Nonsquamous Non-Small Cell Neoplasm of Lung
Non-Small Cell Lung Cancer Metastatic
Non-Small Cell Lung Cancer Stage IIIB
Intervention: Drug: Pemetrexed

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants who completed study treatment and follow-up (FU) were considered to have completed the study. Participants received treatment until disease progression or discontinuation and were followed post treatment (post tx) discontinuation for up to 6 months.

Reporting Groups
  Description
Pemetrexed Pemetrexed: 500 milligrams per meter squared (mg/m^2) administered as an intravenous (IV) infusion over approximately 10 minutes on Day 1 of each 21-day cycle until disease progression or the participant discontinued for any other reason. The first dose of maintenance therapy was administered at the hospital; thereafter, therapy was administered in the home setting by qualified oncology homecare nurses.

Participant Flow:   Overall Study
    Pemetrexed  
STARTED     52  
Received at Least 1 Dose of Study Drug     52  
COMPLETED     51  
NOT COMPLETED     1  
Lost to FU post tx discontinuation                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety Population: Participants who received at least 1 dose of study drug.

Reporting Groups
  Description
Pemetrexed Pemetrexed: 500 mg/m^2 IV infusion over approximately 10 minutes on Day 1 of each 21-day cycle until disease progression or the participant discontinued for any other reason. The first dose of maintenance therapy was administered at the hospital; thereafter, therapy was administered in the home setting by qualified oncology homecare nurses.

Baseline Measures
    Pemetrexed  
Number of Participants  
[units: participants]
  52  
Age  
[units: years]
Median ( Full Range )
  66.0  
  ( 27.0 to 82.5 )  
Gender  
[units: participants]
 
Female     26  
Male     26  
Race/Ethnicity, Customized  
[units: participants]
 
White     48  
Black or African American     4  
Region of Enrollment  
[units: participants]
 
United Kingdom     43  
Sweden     9  
Eastern Cooperative Oncology Group (ECOG) Performance Status [1]
[units: participants]
 
0: Fully Active     14  
1: Restricted     38  
Most Recent Pathological Diagnosis  
[units: participants]
 
Adenocarcinoma, Lung     48  
Adenocarcinoma, Mucinous, No Other Symptoms (NOS)     1  
Adenocarcinoma, Moderately Differentiated, Lung     1  
Carcinoma, Non-Small Cell, Lung NOS     2  
Basis for Most Recent Pathological Diagnosis  
[units: participants]
 
Cytological     10  
Histopathological     42  
Stage of Disease [2]
[units: participants]
 
Stage IIIB     3  
Stage IV     48  
Stage IIIA     1  
Prior Systemic Therapy [3]
[units: participants]
 
Carboplatin + Gemcitabine     9  
Carboplatin + Pemetrexed     19  
Cisplatin + Pemetrexed     20  
Platinum-Based Therapy + Pemetrexed     4  
Best Response to Prior Systemic Therapy [4]
[units: participants]
 
Partial Response (PR)     25  
Stable Disease (SD)     26  
Progressive Disease (PD)     1  
[1] Classified participants according to their functional impairment. Scores could have ranged from 0 (Fully Active) to 5 (Death).
[2] Disease stage described using American Joint Committee on Cancer (AJCC). Stages ranged from I (cancer was small and had not spread to the lymph nodes) to IV (cancer spread throughout the body). Stage III (cancer had spread to nearby tissue or lymph nodes) was further differentiated based on regional lymph nodes: Stage IIIA (spread to nearby lymph nodes) and Stage IIIB (spread to distance lymph nodes). The participant with Stage IIIA disease was enrolled in study because investigator considered participant not eligible for curative treatment.
[3] Prior systemic therapies include carboplatin and gemcitabine; carboplatin and pemetrexed; cisplatin and pemetrexed; platinum-based therapy and pemetrexed. Participants pre-exposed to cisplatin and carboplatin were considered to have platinum-based therapy.
[4] Best response to prior systemic therapy was defined using Response Evaluation Criteria In Solid Tumors [RECIST, version (v) 1.1] criteria. PR was having at least a 30% decrease in sum of longest diameter of target lesions; PD was having at least 20% increase in sum of longest diameter of target lesions and minimum 5 mm increase above nadir; SD was small changes that did not meet above criteria. Participant with PD (borderline tumor increase) was considered a protocol violation.



  Outcome Measures
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1.  Primary:   Percentage of Participants Who Adhered to Treatment Administration at Home   [ Time Frame: Cycle 1, Day 1 through Cycle 19, Day 1 and Cycle 19, Day 1 (21 days/cycle) ]

2.  Secondary:   Change From Baseline in the European Quality of Life Instrument (EQ-5D) Visual Analogue Scale (VAS)   [ Time Frame: Baseline, Day 1 of Cycles 2 and 4 (21 days/cycle) and 30 days post treatment discontinuation ]

3.  Secondary:   Change From Baseline in the EQ-5D Index Score   [ Time Frame: Baseline, Day 1 of Cycles 2 and 4 (21 days/cycle) and 30 days post treatment discontinuation ]

4.  Secondary:   Maximum Improvement Over Baseline in Individual Lung Cancer Symptoms Scale (LCSS) Item Scores   [ Time Frame: Baseline, Day 1 of each cycle (up to Cycle 19, 21 days/cycle), and 30 days post treatment discontinuation ]

5.  Secondary:   Participant Satisfaction: Chemotherapy at Hospital   [ Time Frame: The first evaluation completed at either Cycle 4, Day 1 (21 days/cycle) or 30 days post treatment discontinuation ]

6.  Secondary:   Participant Satisfaction: Chemotherapy at Home   [ Time Frame: The first evaluation completed at either Cycle 4, Day 1 (21 days/cycle) or 30 days post treatment discontinuation ]

7.  Secondary:   Participant Satisfaction: Regarding the Study Nurse   [ Time Frame: The first evaluation completed at either Cycle 4, Day 1 (21 days/cycle) or 30 days post treatment discontinuation ]

8.  Secondary:   Participant Satisfaction: Preferences Regarding Home and/or Hospital Treatment   [ Time Frame: The first evaluation completed at either Cycle 4, Day 1 (21 days/cycle) or 30 days post treatment discontinuation ]

9.  Secondary:   Physician Satisfaction: Distant Management of Participant   [ Time Frame: 30 days post treatment discontinuation ]

10.  Secondary:   Resource Utilization: Number of Participants With an Unplanned Use of Healthcare Resources   [ Time Frame: Cycle 1, Day 1 through last day of cycle when participant reverted to hospital administration or discontinued (up to Cycle 19, 21 days/cycle) ]

11.  Secondary:   Resource Utilization: Unplanned Health Care Visits, Consultations, and Diagnostic Services   [ Time Frame: Cycle 1, Day 1 through last day of cycle when participant reverted to hospital administration or discontinued (up to Cycle 19, 21 days/cycle) ]

12.  Secondary:   Resource Utilization: Duration of Health Care Visits   [ Time Frame: Cycle 2, Day 1 through last day of cycle when participant reverted to hospital administration or discontinued (up to Cycle 4, 21 days/cycle) ]

13.  Secondary:   Resource Utilization: Distances Traveled   [ Time Frame: Cycle 1, Day 1 through last day of cycle when participant reverted to hospital administration or discontinued (up to Cycle 4, 21 days/cycle) ]

14.  Secondary:   Overall Survival (OS) at 6 Months   [ Time Frame: Cycle 1, Day 1 to the date of death from any cause (up to Month 6) ]

15.  Secondary:   Time to Treatment Failure (TTF)   [ Time Frame: Cycle 1, Day 1 to first event (up to Cycle 19, 21 days/cycle) ]

16.  Other Pre-specified:   Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), or Died   [ Time Frame: 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] ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
phone: 800-545-5979


No publications provided by Eli Lilly and Company

Publications automatically indexed to this study:

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
Results First Received: June 12, 2014
Last Updated: October 3, 2014
Health Authority: Sweden: Medical Products Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency