High-dose Pemetrexed to Treat Lung Adenocarcinoma With Brain Metastases

Phase 2

• Conditions: Brain Metastases
• Interventions: Drug: pemetrexed

• Registration Number: NCT02284490
• Lead Sponsor: Rongjie Tao

Brief 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2014-10-10
• Status Verified: 2014-11
• Study Start: 2014-11
• Study First Submitted QC: 2014-11-03
• Last Update Submitted: 2014-11-03
• Study First Posted: 2014-11-06
• Last Update Posted: 2014-11-06
• Primary Completion: 2016-10
• Study Completion: 2017-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• Histologically confirmed brain metastases from lung adenocarcinoma.
• Measurable (greater than 1 cm in diameter) tumor by CT scan or MRI.
• ECOG (Eastern Cooperative Oncology Group) Performance status of 0-1.
• Measurable disease as defined by bidimensionally measurable lesions with clearly defined margins by CT scan or MRI.
• Biopsy is not required if radiographic imaging is consistent with brain metastases.
• Must have failed prior whole-brain radiotherapy.
• Patients with leptomeningeal metastases with or without brain metastases are eligible for therapy (may be diagnosed by MRI or cytology).
• Karnofsky performance score ≥ 60
• WBC > 3,000/mm^3
• Absolute neutrophil count > 1,500/mm^3
• Platelet count > 100,000/mm^3
• Hemoglobin > 10 mg/dL (transfusion allowed)
• SGOT/SGPT < 3.0 times upper limit of normal (ULN)
• Bilirubin < 1.5 times ULN
• Creatinine < 1.5 mg/dL
• Creatinine clearance > 45 mL/min
• Women of childbearing potential and sexually active males must commit to the use of effective contraception while on study and for 3 months after completing study treatment
• Women who are pregnant or breast-feeding are not eligible for study treatment
• Negative pregnancy test
• Able to take steroids, vitamin B12, or folate
• No significant medical illnesses or infection that, in the investigator's opinion, cannot be adequately controlled with appropriate therapy or would compromise the patient's ability to tolerate this therapy

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Exclusion Criteria

• Symptomatic brain metastasis
• Have received prior radiotherapy for brain metastasis
• Unable or unwilling to take folic acid, vitamin B12 supplementation or dexamethasone (or equivalent corticosteroid); or any other inability to comply with protocol or study related procedures.
• A prior malignancy other than NSCLC, except carcinoma in situ of the cervix or non-melanoma skin cancer, adequately treated low grade [Gleason score <6] localized prostate cancer, unless that prior malignancy was diagnosed and definitively treated at least 5 years previously with no subsequent evidence of recurrence
• Serious concomitant systemic disorders (for example, active infection or abnormal electrocardiogram (ECG) indicative of cardiac disease) that, in the opinion of the investigator, would compromise the safety of the patient and his/her ability to complete study.
• Inability to discontinue administration of aspirin at a dose >1.3g/day or other non-steroidal anti-inflammatory agents for 2 days before, the day of, and 2 days after the dose of pemetrexed (5 days prior for long-acting agents such as piroxicam).
• Presence of fluid accumulations in third spaces, e.g., ascite or pleural effusion, which can be detected clinically (during physical examination), and which cannot be adequately controlled by drainage or other procedures prior to inclusion in the study.
• Peripheral neuropathy > CTC Grade 2
• Patient compliance or geographic distance precluding adequate follow up.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment Arm	pemetrexed	Pemetrexed 900 mg/m² every 21 days until disease progression.

Primary Outcome Measures

Name	Time	Method
Determine the 6-month progression-free survival rate in patients with brain metastases from lung adenocarcinoma treated with pemetrexed disodium.	1.5 years

Secondary Outcome Measures

Name	Time	Method
Determine the radiographic response in patients with brain metastases from lung adenocarcinoma treated with pemetrexed disodium.	2 years
Determine the time to response in patients treated with this drug.	2 years
Determine the duration of response in patients treated with this drug.	2 years
Determine the overall survival of patients treated with this drug.	2 years
Collect safety data on patients with brain metastases from lung adenocarcinoma treated with this drug.	2 years

Trial Locations

Locations (1)

Neurosurgery, Shandong Cancer Hospital and Institute; 🇨🇳 Jinan, Shandong, China