Clinical Trials Directory

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UnknownNCT02284490

High-dose Pemetrexed to Treat Lung Adenocarcinoma With Brain Metastases

Status
Unknown
Phase
Phase 2
Study type
Interventional
Enrollment
25 (estimated)
Sponsor
Rongjie Tao · Academic / Other
Sex
All
Age
20 Years – 95 Years
Healthy volunteers
Not accepted

Summary

This phase II trial is studying how well pemetrexed disodium works in treating patients with Lung Adenocarcinoma With Brain Metastases

Detailed description

* Determine the 6-month progression-free survival rate in patients with Lung Adenocarcinoma With Brain Metastases treated with pemetrexed disodium. * Determine the time to progression in patients with Lung Adenocarcinoma With Brain Metastases treated with pemetrexed disodium. Secondary * Determine the radiographic response in patients with Lung Adenocarcinoma With Brain Metastases treated with pemetrexed disodium. * Determine the time to response in patients treated with this drug. * Determine the duration of response in patients treated with this drug. * Determine the overall survival of patients treated with this drug. * Collect safety data on patients with intracranial tumors treated with this drug. OUTLINE: 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. After completion of study treatment, patients are followed periodically. PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.

Conditions

Interventions

TypeNameDescription
DRUGpemetrexedAdministered intravenously at a dose of 900 mg/m2 every 21 days until disease progression.

Timeline

Start date
2014-11-01
Primary completion
2016-10-01
Completion
2017-11-01
First posted
2014-11-06
Last updated
2014-11-06

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT02284490. Inclusion in this directory is not an endorsement.