To Investigate Efficacy and Safety of Pemetrexed as Second or Third Line Therapy in Patients With Non-small Cell Lung Cancer (NSCLC)

Phase 2CompletedNCT00191191

Eli Lilly and Company226 enrolled

Overview

To investigate efficacy and safety of pemetrexed as second or third line therapy in patients with non-small cell lung cancer (NSCLC).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

226

Conditions

Non-small Cell Lung Cancer

Interventions

Pemetrexed 500 mg/m2DRUG

500 mg/m2, intravenous (IV), every 21 days, one year from registration date

Pemetrexed 1000 mg/m2DRUG

1000 mg/m2, intravenous (IV), every 21 days, one year from registration date

Eligibility

Sex: ALLMin age: 20 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Clinical stage III or IV * Previously treated with one or two chemotherapeutic regimens * Performance status: 0-2 Exclusion Criteria: \- Inability or unwillingness to take folic acid or vitamin B12 supplementation

Locations (16)

Outcomes

Primary Outcomes

Best Overall Response

Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria as determined by the Case Judgment Committee. Best overall response was defined as the most favorable overall response recorded for each patient during the observation period. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.

Time frame: baseline to measured progressive disease (up to 3.2 years)

Secondary Outcomes

Duration of Response

The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression.

Time frame: time of response to progressive disease (up to 3.2 years)

Progression-Free Survival (PFS)

PFS was defined as time from the scheduled date of the first treatment cycle until the date of confirmation of progressive disease on the overall response rating. For patients who died before confirmation of progressive disease, the number of days until the date of death (from any cause) was handled as progression-free survival.

Time frame: baseline to measured progressive disease (up to 3.2 years)

Change From Baseline to 3 Months in Quality of Life Questionnaire for Cancer Patients Treated With Anticancer Drugs (QOL-ACD)

20-items assessed quality of life in patients undergoing chemotherapy. Scores range from 1 (not at all/very poor) to 5 (very much/very well). Face scale scores (patient circles number of the face that best fits his/her feelings) range from 1 (sad face) to 5 (smiling face). Item scores were grouped according to Functional (daily activity: 5 items), Physical (5 items), Emotional (psychological condition: 4 items), Social Attitude (5 items), and Face Scale (1 item). Score of subscales were converted to scores with range from 0 to 100. Higher scores represent higher QOL.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician

Chiba, Japan

Ehime, Japan

Fukuoka, Japan

Gifu, Japan

Gunma, Japan

Hokkaido, Japan

Hyōgo, Japan

Kanagawa, Japan

Kumamoto, Japan

Miyagi, Japan

...and 6 more locations