High-dose Pemetrexed to Treat Lung Adenocarcinoma With Brain Metastases

Brain Metastases Clinical Trial

Official title:

High-dose Pemetrexed to Treat Lung Adenocarcinoma With Brain Metastases

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02284490
• Other study ID #: ShandongCHI003
• Secondary ID: ShandongCHI
• Status: Not yet recruiting
• Phase: Phase 2
• First received: October 10, 2014
• Last updated: November 3, 2014
• Start date: November 2014
• Est. completion date: November 2017

Study information

• Verified date: November 2014
• Source: Shandong Cancer Hospital and Institute
• Contact: Yong Wang, M.D
• Phone: +6813365318361
• Email: doctorwy[@]163.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 25
• Est. completion date: November 2017
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 95 Years

Eligibility

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

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Brain Metastases
• Brain Neoplasms
• Neoplasm Metastasis

Intervention

Drug:
• pemetrexed
Administered intravenously at a dose of 900 mg/m2 every 21 days until disease progression.

Locations

Country	Name	City	State
China	Neurosurgery, Shandong Cancer Hospital and Institute	Jinan	Shandong

Sponsors (2)

Lead Sponsor	Collaborator
Rongjie Tao	National Natural Science Foundation of China

Country where clinical trial is conducted

China, 

References & Publications (5)

Bailon O, Chouahnia K, Augier A, Bouillet T, Billot S, Coman I, Ursu R, Belin C, Zelek L, Des Guetz G, Levy C, Carpentier AF, Morere JF. Upfront association of carboplatin plus pemetrexed in patients with brain metastases of lung adenocarcinoma. Neuro Onc — View Citation

Dinglin XX, Huang Y, Liu H, Zeng YD, Hou X, Chen LK. Pemetrexed and cisplatin combination with concurrent whole brain radiotherapy in patients with brain metastases of lung adenocarcinoma: a single-arm phase II clinical trial. J Neurooncol. 2013 May;112(3 — View Citation

Ito S, Ogawa Y, Harada H, Yamaguchi T, Munakata K. [Long-term survival of patient with brain metastases from lung cancer treated by pemetrexed monotherapy]. Gan To Kagaku Ryoho. 2012 May;39(5):793-6. Japanese. — View Citation

Yang H, Yang X, Zhang Y, Liu X, Deng Q, Zhao M, Xu X, He J. Erlotinib in combination with pemetrexed/cisplatin for leptomeningeal metastases and cerebrospinal fluid drug concentrations in lung adenocarcinoma patients after gefitinib faliure. Target Oncol. — View Citation

Zhuang H, Yuan Z, Wang J, Zhao L, Pang Q, Wang P. Phase II study of whole brain radiotherapy with or without erlotinib in patients with multiple brain metastases from lung adenocarcinoma. Drug Des Devel Ther. 2013 Oct 8;7:1179-86. doi: 10.2147/DDDT.S53011 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the 6-month progression-free survival rate in patients with brain metastases from lung adenocarcinoma treated with pemetrexed disodium.		1.5 years	Yes
Secondary	Determine the radiographic response in patients with brain metastases from lung adenocarcinoma treated with pemetrexed disodium.		2 years	Yes
Secondary	Determine the time to response in patients treated with this drug.		2 years	Yes
Secondary	Determine the duration of response in patients treated with this drug.		2 years	Yes
Secondary	Determine the overall survival of patients treated with this drug.		2 years	Yes
Secondary	Collect safety data on patients with brain metastases from lung adenocarcinoma treated with this drug.		2 years	Yes