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

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ClinicalTrials.gov Identifier: NCT02426658
Recruitment Status : Active, not recruiting
First Posted : April 27, 2015
Results First Posted : March 18, 2020
Last Update Posted : November 30, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Brief 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.

Condition or disease Intervention/treatment Phase
Stage IV Non-Small Cell Lung Cancer Other: Laboratory Biomarker Analysis Drug: Pemetrexed Disodium Other: Quality-of-Life Assessment Phase 2

Detailed Description:

PRIMARY OBJECTIVES:

I. To evaluate the effect of single agent pemetrexed (pemetrexed disodium) on tumor progression in ECOG performance status 3 patients with stage IV non-squamous histology non-small cell lung cancer in a single arm pilot study.

II. To evaluate the effect of single agent pemetrexed on quality of life in ECOG performance status 3 patients with stage IV non-squamous histology non-small cell lung cancer in a single arm pilot study.

SECONDARY OBJECTIVES:

I. To evaluate toxicity associated with single agent pemetrexed on tumor progression in ECOG performance status 3 patients with stage IV non-squamous histology non-small cell lung cancer in a single arm pilot study.

OUTLINE:

Patients receive pemetrexed disodium intravenously (IV) over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for at least 30 days and then every 6 weeks thereafter.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study Evaluating Pemetrexed in ECOG Performance Status 3 Patients With Stage IV Non-squamous Non-small Cell Lung Cancer
Actual Study Start Date : May 2015
Actual Primary Completion Date : June 7, 2018
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment (pemetrexed disodium)
Patients receive pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Quality-of-Life Assessment and Laboratory Biomarker Analysis.
Other: Laboratory Biomarker Analysis
Correlative studies

Drug: Pemetrexed Disodium
Given IV
Other Names:
  • Alimta
  • LY231514
  • N-[4-[2-(2-Amino-4,7-dihydro-4-oxo-1H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl]-L-glutamic Acid Disodium Salt

Other: Quality-of-Life Assessment
QOL studies
Other Name: Quality of Life Assessment




Primary Outcome Measures :
  1. 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) [ Time Frame: Baseline to 12 weeks ]
    Quality of life will be assessed at each treatment time (i.e. every three weeks). A longitudinal mixed models analysis will be used to look at QOL over the time course. A paired t-test will also be calculated to see if the average change is more than 0 (worsening) versus a two-sided alternative that the difference is 0 or better. Score range from 0-100 (1 = not at all, 2 = a little, 3 = quite a bit, or 4 = very much). The higher the score, the greater the change in the quality of life for the worse.

  2. Time to Tumor Progression [ Time Frame: The duration of time from the start of treatment to the time of progression, death, or date of last contact, assessed up to 2 years ]
    It will be determined whether each patient has a progression (or dies) before or after 12 weeks. A 95% exact (Clopper Pearson) confidence interval will then be around the proportion with PFS greater than or equal to 12 weeks. If this confidence interval includes 50% then that would provide evidence that the therapy is potentially promising. If the upper bound of the confidence interval does not include 50% then this would indicate that the treatment may not be promising for patients. In addition, a Kaplan Meier survival curve will be constructed to describe the time to progression data.


Secondary Outcome Measures :
  1. Incidence of Hematologic Toxicity, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 [ Time Frame: Up to 30 days ]
    The number and type of toxicities observed during this protocol will be estimated, focusing on unexpected grade 3 or higher toxicities. No formal statistical tests will be done on these estimates.

  2. Overall Survival [ Time Frame: The duration of time from the start of treatment to date of death or date of last contact, assessed up to 2 years ]
    Examined by estimating a Kaplan-Meier survival curve using all patients enrolled.

  3. Response Rate [ Time Frame: Up to 2 years ]
    Response rate will be estimated every 6 weeks for patients, and these estimates will be presented with confidence intervals.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02426658


Locations
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United States, North Carolina
Comprehensive Cancer Center of Wake Forest University
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University Health Sciences
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Stefan Grant Wake Forest University Health Sciences
  Study Documents (Full-Text)

Documents provided by Wake Forest University Health Sciences:
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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT02426658    
Other Study ID Numbers: IRB00032417
NCI-2015-00596 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CCCWFU 62115
CCCWFU # 62115 ( Other Identifier: Comprehensive Cancer Center of Wake Forest University )
P30CA012197 ( U.S. NIH Grant/Contract )
First Posted: April 27, 2015    Key Record Dates
Results First Posted: March 18, 2020
Last Update Posted: November 30, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Pemetrexed
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors