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High-dose Pemetrexed to Treat Lung Adenocarcinoma With Brain Metastases

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ClinicalTrials.gov Identifier: NCT02284490
Recruitment Status : Unknown
Verified November 2014 by Rongjie Tao, Shandong Cancer Hospital and Institute.
Recruitment status was:  Not yet recruiting
First Posted : November 6, 2014
Last Update Posted : November 6, 2014
Sponsor:
Collaborator:
National Natural Science Foundation of China
Information provided by (Responsible Party):
Rongjie Tao, Shandong Cancer Hospital and Institute

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

Condition or disease Intervention/treatment Phase
Brain Metastases Drug: pemetrexed Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: High-dose Pemetrexed to Treat Lung Adenocarcinoma With Brain Metastases
Study Start Date : November 2014
Estimated Primary Completion Date : October 2016
Estimated Study Completion Date : November 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment Arm
Pemetrexed 900 mg/m² every 21 days until disease progression.
Drug: pemetrexed
Administered intravenously at a dose of 900 mg/m2 every 21 days until disease progression.
Other Names:
  • pemetrexed disodium
  • Alimta




Primary Outcome Measures :
  1. Determine the 6-month progression-free survival rate in patients with brain metastases from lung adenocarcinoma treated with pemetrexed disodium. [ Time Frame: 1.5 years ]

Secondary Outcome Measures :
  1. Determine the radiographic response in patients with brain metastases from lung adenocarcinoma treated with pemetrexed disodium. [ Time Frame: 2 years ]
  2. Determine the time to response in patients treated with this drug. [ Time Frame: 2 years ]
  3. Determine the duration of response in patients treated with this drug. [ Time Frame: 2 years ]
  4. Determine the overall survival of patients treated with this drug. [ Time Frame: 2 years ]
  5. Collect safety data on patients with brain metastases from lung adenocarcinoma treated with this drug. [ Time Frame: 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT02284490


Contacts
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Contact: Yong Wang, M.D +6813365318361 doctorwy@163.com

Locations
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China, Shandong
Neurosurgery, Shandong Cancer Hospital and Institute
Jinan, Shandong, China, 250117
Sponsors and Collaborators
Rongjie Tao
National Natural Science Foundation of China

Publications of Results:
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Responsible Party: Rongjie Tao, Neurosurgery, Shandong Cancer Hospital and Institute
ClinicalTrials.gov Identifier: NCT02284490     History of Changes
Other Study ID Numbers: ShandongCHI003
ShandongCHI ( Registry Identifier: ShandongCHI )
First Posted: November 6, 2014    Key Record Dates
Last Update Posted: November 6, 2014
Last Verified: November 2014

Keywords provided by Rongjie Tao, Shandong Cancer Hospital and Institute:
Brain Metastases

Additional relevant MeSH terms:
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Adenocarcinoma
Neoplasm Metastasis
Neoplasms, Second Primary
Brain Neoplasms
Adenocarcinoma of Lung
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplastic Processes
Pathologic Processes
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Pemetrexed
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors