A Study of Home Administration of Pemetrexed as Maintenance Treatment for Advanced Nonsquamous No… (NCT01473563) | Clinical Trial Compass
CompletedPhase 2
A Study of Home Administration of Pemetrexed as Maintenance Treatment for Advanced Nonsquamous Non-Small Cell Lung Cancer (NSCLC)
Sweden, United Kingdom52 participantsStarted 2011-12
Plain-language 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?
Who can participate
Age range18 Years
SexALL
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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 …
What they're measuring
1
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)