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Pemetrexed (ALIMTA) and Gefitinib (IRESSA®) in Never-Smoker and Adenocarcinoma Patients With Non-Small Cell Lung Cancer Previously Treated With Platinum-Based Chemotherapy

Primary Purpose

Non-small Cell Lung Cancer

Status
Unknown status
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
iressa
alimta
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring Non-Small Cell Lung Cancer, Never-Smoker and Adenocarcinoma patients, Pemetrexed (ALIMTA), Gefitinib (IRESSA®)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Histologically confirmed pulmonary adenocarcinoma including bronchioloalveolar, but except adenosquamous cell carcinoma
  2. Stage IIIB (malignant pleural effusion and/or pleural seeding), stage IV and relapsed non-small cell lung cancer
  3. Failed with 1st line platinum-based chemotherapy or relapsed within 12 months after adjuvant platinum-based chemotherapy)
  4. Never smoker (less than 100 cigarette for the life time)
  5. 18 year or older
  6. ECOG 0-2
  7. No history of biologic or immunotherapy
  8. Tolerable renal function ( creatine clearance rate is 60ml/min or more)
  9. Tolerable hepatic function (Serum bilirubin ≤ 1.25 x UNL, AST (SGOT) and ALT (SGPT) ≤ 2.5 x UNL, alkaline phosphatase ≤5 x UNL)

Exclusion Criteria:

  1. symptomatic brain metastasis
  2. previously treated with EGFR tyrosine kinase inhibitor
  3. previously treated with antifolate agents
  4. poor oral absorption
  5. patients with active infection
  6. uncontrolled diabetes mellitus
  7. significant cardiovascular disease (uncontrolled hypertension, history of myocardial infarction or unstable angina within 6 months, congestive heart failure)
  8. pregnant or nursing patients
  9. history of malignant disease within 3 years before the enrollment except for cured non-melanomatous skin cancer, cervical carcinoma in situ, or thyroid carcinoma

Sites / Locations

  • Samsung Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

gefitinib

pemetrexed

Arm Description

Outcomes

Primary Outcome Measures

progression-free survival

Secondary Outcome Measures

overall survival
objective response rate
toxicity

Full Information

First Posted
February 8, 2010
Last Updated
February 9, 2010
Sponsor
Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01066195
Brief Title
Pemetrexed (ALIMTA) and Gefitinib (IRESSA®) in Never-Smoker and Adenocarcinoma Patients With Non-Small Cell Lung Cancer Previously Treated With Platinum-Based Chemotherapy
Official Title
A Phase III, Multi-center, Randomized Trial of Pemetrexed and Gefitinib in Never-smoker and Adenocarcinoma Patients With Non-small Cell Lung Cancer Previously Treated With Platinum-based Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2010
Overall Recruitment Status
Unknown status
Study Start Date
May 2008 (undefined)
Primary Completion Date
October 2010 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Samsung Medical Center

4. Oversight

5. Study Description

Brief Summary
Pemetrexed was known to be effective to pulmonary adenocarcinoma and gefitinib was known to be more effective to non-small cell lung cancer (NSCLC) patients with clinical characteristics such as adenocarcinoma, never smoker and female. The investigators try to evaluate which drug (pemetrexed vs gefitinib) is more efficious to NSCLC patients with clinical characteristics such as adenocarcinoma and never smoking history as second- or further-line therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer
Keywords
Non-Small Cell Lung Cancer, Never-Smoker and Adenocarcinoma patients, Pemetrexed (ALIMTA), Gefitinib (IRESSA®)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
129 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
gefitinib
Arm Type
Experimental
Arm Title
pemetrexed
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
iressa
Intervention Description
iressa 250mg per day every day
Intervention Type
Drug
Intervention Name(s)
alimta
Intervention Description
alimta 500mg/m2 every 3 weeks
Primary Outcome Measure Information:
Title
progression-free survival
Time Frame
36 months
Secondary Outcome Measure Information:
Title
overall survival
Time Frame
36 months
Title
objective response rate
Time Frame
36 months
Title
toxicity
Time Frame
36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically confirmed pulmonary adenocarcinoma including bronchioloalveolar, but except adenosquamous cell carcinoma Stage IIIB (malignant pleural effusion and/or pleural seeding), stage IV and relapsed non-small cell lung cancer Failed with 1st line platinum-based chemotherapy or relapsed within 12 months after adjuvant platinum-based chemotherapy) Never smoker (less than 100 cigarette for the life time) 18 year or older ECOG 0-2 No history of biologic or immunotherapy Tolerable renal function ( creatine clearance rate is 60ml/min or more) Tolerable hepatic function (Serum bilirubin ≤ 1.25 x UNL, AST (SGOT) and ALT (SGPT) ≤ 2.5 x UNL, alkaline phosphatase ≤5 x UNL) Exclusion Criteria: symptomatic brain metastasis previously treated with EGFR tyrosine kinase inhibitor previously treated with antifolate agents poor oral absorption patients with active infection uncontrolled diabetes mellitus significant cardiovascular disease (uncontrolled hypertension, history of myocardial infarction or unstable angina within 6 months, congestive heart failure) pregnant or nursing patients history of malignant disease within 3 years before the enrollment except for cured non-melanomatous skin cancer, cervical carcinoma in situ, or thyroid carcinoma
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Myungju Ahn, Ph.D., M.D.
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Pemetrexed (ALIMTA) and Gefitinib (IRESSA®) in Never-Smoker and Adenocarcinoma Patients With Non-Small Cell Lung Cancer Previously Treated With Platinum-Based Chemotherapy

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