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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

Tracking Information
First Submitted Date  ICMJE October 10, 2014
First Posted Date  ICMJE November 6, 2014
Last Update Posted Date November 6, 2014
Study Start Date  ICMJE November 2014
Estimated Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 3, 2014)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 3, 2014)
  • Determine the radiographic response in patients with brain metastases from lung adenocarcinoma treated with pemetrexed disodium. [ Time Frame: 2 years ]
  • Determine the time to response in patients treated with this drug. [ Time Frame: 2 years ]
  • Determine the duration of response in patients treated with this drug. [ Time Frame: 2 years ]
  • Determine the overall survival of patients treated with this drug. [ Time Frame: 2 years ]
  • Collect safety data on patients with brain metastases from lung adenocarcinoma treated with this drug. [ Time Frame: 2 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE High-dose Pemetrexed to Treat Lung Adenocarcinoma With Brain Metastases
Official Title  ICMJE High-dose Pemetrexed to Treat Lung Adenocarcinoma With Brain Metastases
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Brain Metastases
Intervention  ICMJE Drug: pemetrexed
Administered intravenously at a dose of 900 mg/m2 every 21 days until disease progression.
Other Names:
  • pemetrexed disodium
  • Alimta
Study Arms  ICMJE Experimental: Treatment Arm
Pemetrexed 900 mg/m² every 21 days until disease progression.
Intervention: Drug: pemetrexed
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 3, 2014)
25
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2017
Estimated Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 95 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02284490
Other Study ID Numbers  ICMJE ShandongCHI003
ShandongCHI ( Registry Identifier: ShandongCHI )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Rongjie Tao, Shandong Cancer Hospital and Institute
Study Sponsor  ICMJE Rongjie Tao
Collaborators  ICMJE National Natural Science Foundation of China
Investigators  ICMJE Not Provided
PRS Account Shandong Cancer Hospital and Institute
Verification Date November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP