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

LY231514 500 mg/m2 and LY231514 1000 mg/m2 in Patients With Advanced Non-Small Cell Lung Cancer Who Were Previously Treated With Prior Systemic Anti Cancer Therapy: A Randomized Phase II Trial

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00191191

Enrollment

226

Registered

2005-09-19

Start date

2004-10-31

Completion date

2008-10-31

Last updated

2009-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small Cell Lung Cancer

Brief summary

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

Interventions

DRUGPemetrexed 500 mg/m2

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

DRUGPemetrexed 1000 mg/m2

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Best Overall Response	baseline to measured progressive disease (up to 3.2 years)	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.

Secondary

Measure	Time frame	Description
Duration of Response	time of response to progressive disease (up to 3.2 years)	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.
Progression-Free Survival (PFS)	baseline to measured progressive disease (up to 3.2 years)	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.
Change From Baseline to 3 Months in Quality of Life Questionnaire for Cancer Patients Treated With Anticancer Drugs (QOL-ACD)	Baseline (pre-dose), 3 Months after first dose of Cycle 1	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.
Change From Baseline to 3 Months in Functional Assessment of Cancer Therapy for Lung Cancer (FACT-L) Lung Cancer Subscale (LCS)	Baseline (pre-dose), 3 Months after first dose of Cycle 1	FACT-L LCS measured health-related quality of life (HR-QL) related to additional concerns of lung cancer. Original LCS subscale scores range from 0 to 28, but the scores were converted to scores with a range of 0 to 100 in this study. Higher scores represent better HR-QL.

Countries

Japan

Participant flow

Pre-assignment details

Baseline demographics and efficacy outcome measures are provided for the Full Analysis Set population (all randomized participants who met all inclusion and no exclusion criteria and received at least one dose of study drug).

Participants by arm

Arm	Count
Pemetrexed 500 mg/m2 Pemetrexed 500 mg/m2, intravenous, every 21 days	108
Pemetrexed 1000 mg/m2 Pemetrexed 1000 mg/m2, intravenous, every 21 days	108
Total	216

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Adverse Event	11	21
Overall Study	Entry Criteria Exclusion	2	0
Overall Study	Family/Caregiver Decision	5	7
Overall Study	Good Clinical Practice Violation	0	1
Overall Study	Lost to Follow-up	1	0
Overall Study	Physician Decision	3	2
Overall Study	Progressive Disease	84	72
Overall Study	Toxicity After Dose Reduction	7	8
Overall Study	Treated with Another Systemic Agent	1	1

Baseline characteristics

Characteristic	Pemetrexed 500 mg/m2	Pemetrexed 1000 mg/m2	Total
Age Continuous	60.8 years STANDARD_DEVIATION 8.7	61.3 years STANDARD_DEVIATION 8.8	61.1 years STANDARD_DEVIATION 8.7
Eastern Cooperative Oncology Group (ECOG) Performance Status 0 - Fully Active	43 participants	36 participants	79 participants
Eastern Cooperative Oncology Group (ECOG) Performance Status 1 - Ambulatory, Restricted Strenuous Activity	59 participants	66 participants	125 participants
Eastern Cooperative Oncology Group (ECOG) Performance Status 2 - Ambulatory, No Work Activities	6 participants	6 participants	12 participants
Height	161.0 centimeters (cm) STANDARD_DEVIATION 7.9	161.1 centimeters (cm) STANDARD_DEVIATION 8.7	161.0 centimeters (cm) STANDARD_DEVIATION 8.3
Histological Types Adenocarcinoma	77 participants	80 participants	157 participants
Histological Types Adenosquamous Carcinoma	1 participants	0 participants	1 participants
Histological Types Large Cell Carcinoma	5 participants	1 participants	6 participants
Histological Types Other	2 participants	2 participants	4 participants
Histological Types Squamous Cell Carcinoma	23 participants	25 participants	48 participants
Region of Enrollment Japan	108 participants	108 participants	216 participants
Sex: Female, Male Female	40 Participants	39 Participants	79 Participants
Sex: Female, Male Male	68 Participants	69 Participants	137 Participants
Weight	59.8 kilograms STANDARD_DEVIATION 9.9	59.1 kilograms STANDARD_DEVIATION 11.9	59.5 kilograms STANDARD_DEVIATION 10.9

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	114 / 114	111 / 111
serious Total, serious adverse events	19 / 114	21 / 111

Outcome results

Primary

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)