NCT00830245

Brief Summary

To assess the efficacy and safety of erlotinib for non-small cell lung cancer patients with leptomeningeal carcinomatosis

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2009

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

January 24, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 27, 2009

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

July 26, 2011

Status Verified

July 1, 2011

Enrollment Period

2.5 years

First QC Date

January 24, 2009

Last Update Submit

July 25, 2011

Conditions

Leptomeningeal CarcinomatosisNon-small Cell Lung Cancer

Keywords

EGFR mutationErlotinibLung cancerleptomeningeal carcinomatosis in EGFR mutation positive non-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    1 year

Secondary Outcomes (7)

  • Cytology negative conversion rate

    1 month, 2 months, 3 months, 4 months

  • Neurologic symptom improvement

    1 month, 2 months, 3 months, 4 months

  • Response rate (extra-cranial disease)

    2 months, 4 months

  • Response rate (brain)

    2 months, 4 months

  • Quality of life

    1 month, 2 months, 3 months, 4 months

  • +2 more secondary outcomes

Study Arms (1)

Erlotinib

EXPERIMENTAL

Erlotinib 150mg/day (if no negative conversion --\> increment to 250mg/day)

Drug: Erlotinib

Interventions

ErlotinibDRUG

Erlotinib 150mg/day

Erlotinib

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>18
  • Histologically or pathologically proven non-small cell lung cancer (NSCLC)
  • Leptomeningeal carcinomatosis confirmed by CSF cytology
  • A patients with EGFR mutation (including exon 19 deletion, L858R)
  • ECOG performance status 0-3
  • Expected life time more than at least 4 weeks
  • A patients who signed the informed consent prior to the participation in the study
  • Chemotherapy-naïve patient is eligible
  • Previous EGFR TKI is allowed if this drug was not specifically used for CNS metastases

You may not qualify if:

  • A pregnant or lactating patient
  • A patient of childbearing potential without being tested for pregnancy at baseline or with a positive test. (A postmenopausal woman with the amenorrhea period of at least 12 months or longer is considered to have non-childbearing potential.)
  • A man or woman of childbearing potential without the willingness to use a contraceptive measures during the study
  • A patient with history of another malignant disease within past 3 years, except curatively treated basal cell carcinoma of the skin, cervical carcinoma in situ, and early gastric cancer
  • A patient with active interstitial lung disease, except simple lymphangitic lung metastasis
  • A patient with history of allergic reaction to gefitinib or erlotinib
  • The following laboratory test results:
  • Number of absolute neutrophils counts (ANC) \< 1.0ⅹ109/L
  • Number of platelets \< 50 ⅹ109/L
  • AST, ALT \> 2.5 ⅹupper limit of normal
  • Total bilirubin \> 1.5 ⅹupper limit of normal
  • Serum creatinine \> 1.5 ⅹupper limit of normal
  • A patient with serious disease as followings
  • Uncontrolled cardiac arrhythmia
  • History of myocardial infarction within 6 months prior to the initiation of study
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dae Seog Heo

Seoul, South Korea

Location

MeSH Terms

Conditions

Meningeal CarcinomatosisCarcinoma, Non-Small-Cell LungLung Neoplasms

Interventions

Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Meningeal NeoplasmsCentral Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System DiseasesCarcinoma, BronchogenicBronchial NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

QuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 24, 2009

First Posted

January 27, 2009

Study Start

January 1, 2009

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

July 26, 2011

Record last verified: 2011-07

Locations

KR(1)