Phase 2 N=16 Treatment

Pemetrexed Disodium in Treating Patients With Stage IV Non-small Cell Lung Cancer and ECOG Performance Status 3

Stage IV Non-Small Cell Lung Cancer

Bottom Line

View on ClinicalTrials.gov: NCT02426658 ↗

Enrolled (actual)

Serious AEs

92.3%

Results posted

Mar 2020

Primary outcome: Primary: Change in Quality of Life (QOL), Assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (QLQ-C30) and QLQ-Lung Cancer 13-item (LC13) — 51.2821; 58.3333 score on a scale — p=0.7044

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Laboratory Biomarker Analysis (Other); Pemetrexed Disodium (Drug); Quality-of-Life Assessment (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Wake Forest University Health Sciences
Primary completion: Apr 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Quality of Life (QOL), Assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (QLQ-C30) and QLQ-Lung Cancer 13-item (LC13)	51.2821; 58.3333	0.7044
PRIMARY Time to Tumor Progression	2.0	—
SECONDARY Incidence of Hematologic Toxicity, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0	13; 3; 1; 1; 9; 11	—
SECONDARY Overall Survival	2.4	—
SECONDARY Response Rate	1; 6; 2	—

Summary

This pilot phase II trial studies how well pemetrexed disodium works in treating patients with stage IV non-small cell lung cancer and an Eastern Cooperative Oncology Group (ECOG) performance status of 3. Performance status means how well patients are able to perform daily activities and care for themselves. Patients with a performance status of 3 have a limited ability to move around. Currently, only patients who are able to perform most of their daily activities may receive chemotherapy, due to the side effects it may cause. Pemetrexed disodium causes fewer side effects than many chemotherapy drugs and may help treat patients with stage IV non-small cell lung cancer and a lower performance status.

Eligibility Criteria

Inclusion Criteria

Patients must have histologically confirmed Stage IV non-squamous histology non-small cell lung cancer
ECOG performance status of 3
Sensitizing epidermal growth factor receptor (EGFR), anaplastic lymphoma receptor tyrosine kinase (ALK) and ROS proto-oncogene 1, receptor tyrosine kinase (ROS-1) mutations are either negative or unknown
Absolute neutrophil count >= 1,500/mcL
Platelets >= 100,000/mcL
Creatinine clearance >= 45 mL/min
Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
Ability to understand and the willingness to sign an Institutional Review Board (IRB)-approved informed consent document
Ability to understand and complete the European Organization for Research and Treatment of Cancer (EORTC) quality of life (QOL) instruments

Exclusion Criteria

Patients who have previously received chemotherapy for non-small cell lung cancer, or have received radiotherapy within 2 weeks prior to entering the study, or who have not recovered from adverse events due to treatment more than 2 weeks earlier
Patients whose tumors are positive for the sensitizing EGFR mutation
Patients whose tumors are positive for the sensitizing ALK fusion
Patients whose tumors are positive for the sensitizing ROS-1 fusion
Patients may not be receiving any other investigational agents
Patients with symptomatic or recurrent brain metastases should be excluded from this clinical trial
History of allergic reactions attributed to compounds of similar chemical or biologic composition to pemetrexed
Pregnant women are excluded from this study; breastfeeding should be discontinued

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02426658). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.