An Observational Study of the Ethnic Impact of Patients Undergoing Second (2nd) Line Treatment for Non-Small Cell Lung Cancer Using Pemetrexed
Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT00497770
Collaborator
(none)
434
38
48.9
11.4
0.2
Study Details
Study Description
Brief Summary
This large, non-randomized observational study is being conducted to provide data about the impact of ethnic origin on outcomes and resource utilization during the 2nd line treatment of non-small cell lung cancer (NSCLC) in a routine medical care setting.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Detailed Description
This is a large 1000 patient single arm observational study being conducted to determine the impact of ethnic origin (Caucasian, African-Americans, Asian-Americans, and Hispanics) on patients being treated for 2nd line advanced NSCLC with pemetrexed given in routine clinical practice. Data will be collected on disease control rate by pemetrexed as defined by Response Rate (RR) (Complete Response (CR) + Partial Response (PR)), Stable Disease (SD) and toxicities. In addition, overall survival, progression-free survival, treatment toxicities, activities of daily living, symptom burden and resource utilization will also be observed. To meet the study goals, a total of 400 Caucasians, 200 African- Americans, 200 Asian-Americans, and 200 Hispanics will be accrued to this study.
Study Design
Study Type:
Observational
Actual Enrollment
:
434 participants
Time Perspective:
Prospective
Official Title:
Non-small Cell Lung Cancer: The Impact of Ethnic Origin on Patients Being Treated Second Line With Pemetrexed - An Observational Study
Study Start Date
:
Feb 1, 2007
Actual Primary Completion Date
:
Mar 1, 2011
Actual Study Completion Date
:
Mar 1, 2011
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Caucasian Caucasian patients receiving Alimta for 2nd line NSCLC |
Drug: Pemetrexed
Treatment pattern and treatment initiation or changes are solely at the discretion of the physician and the patient
Other Names:
|
| African American African American patients receiving Alimta for 2nd line NSCLC |
Drug: Pemetrexed
Treatment pattern and treatment initiation or changes are solely at the discretion of the physician and the patient
Other Names:
|
| Asian American Asian American patients receiving Alimta for 2nd line NSCLC |
Drug: Pemetrexed
Treatment pattern and treatment initiation or changes are solely at the discretion of the physician and the patient
Other Names:
|
| Hispanic Hispanic patients receiving Alimta for 2nd line NSCLC |
Drug: Pemetrexed
Treatment pattern and treatment initiation or changes are solely at the discretion of the physician and the patient
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants With a Best Overall Disease Control Response (Disease Control Rate) [baseline to measured progressive disease (up to 20 cycles [14 months])]
Disease Control Rate [DCR] is the percentage of participants with Complete Response (CR), Partial Response (PR), Stable Disease (SD), and SD or Incomplete Response (SI). Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. CR=disappearance of all target lesions; PR=30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD)=20% increase in sum of longest diameter of target lesions; SD=small changes not meeting above criteria; SI=persistence of 1 or more non-target lesion(s) and/or maintenance of tumor marker level above normal limits.
Secondary Outcome Measures
- Overall Survival [baseline to date of death from any cause (up to 20 cycles [14 months])]
Overall survival is the duration (months) from enrollment to death. For patients who are alive, overall survival is censored at the last contact.
- Progression Free Survival [baseline to measured progressive disease or death (up to 20 cycles [14 months])]
Time from start of second line therapy until death, disease progression, or last contact expressed in months. Participants lost to follow-up (that were alive at last contact) were treated as censored using Kaplan-Meier survival analysis method.
- Functional Status Based on Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to Plan and Prepare Meals [beginning and at end of pemetrexed treatment (up to 20 cycles [14 months])]
The daily activities assessed: ability to plan and prepare meals. OARS-IADL assesses the participant's ability to plan and prepare meals at baseline and end of treatment. Responses: ability to do the activity without help, some help, unable, or not done (missing). The percent of participants responding in the different levels of functional ability are provided.
- Functional Status Based on the Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to Drive or Use Public Transportation [beginning and at end of pemetrexed treatment (up to 20 cycles [14 months])]
The daily activities assessed: ability to drive or use public transportation. OARS-IADL assesses the participant's ability to drive or use public transportation at baseline and end of treatment. Responses: ability to do the activity without help, some help, unable, or not done (missing). The percent of participants responding in the different levels of functional ability are provided.
- Functional Status Based on the Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to Handle Personal Finances [beginning and at end of pemetrexed treatment (up to 20 cycles [14 months])]
The daily activities assessed: ability to handle personal finances. OARS-IADL assesses the participant's ability to handle personal finances at baseline and end of treatment. Responses: ability to do the activity without help, some help, unable, or not done (missing). The percent of participants responding in the different levels of functional ability are provided.
- Functional Status Based on the Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to Perform Housework Activities [beginning and at end of pemetrexed treatment (up to 20 cycles [14 months])]
The daily activities assessed: ability to perform housework activities. OARS-IADL assesses the participant's ability to perform housework activities at baseline and end of treatment. Responses: ability to do the activity without help, some help, unable, or not done (missing). The percent of participants responding in the different levels of functional ability are provided.
- Functional Status Based on the Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to Prepare and Take Medications [beginning and at end of pemetrexed treatment (up to 20 cycles [14 months])]
The daily activities assessed: ability to prepare and take medications. OARS-IADL assesses the participant's ability to prepare and take medications at baseline and end of treatment. Responses: ability to do the activity without help, some help, unable, or not done (missing). The percent of participants responding in the different levels of functional ability are provided.
- Functional Status Based on the Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to do the Act of Shopping [beginning and at end of pemetrexed treatment (up to 20 cycles [14 months])]
The daily activities assessed: ability to do the act of shopping. OARS-IADL assesses the participant's ability to do the act of shopping at baseline and end of treatment. Responses: ability to do the activity without help, some help, unable, or not done (missing). The percent of participants responding in the different levels of functional ability are provided.
- Functional Status Based on the Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to Operate the Telephone [beginning and at end of pemetrexed treatment (up to 20 cycles [14 months])]
The daily activities assessed: ability to operate the telephone. OARS-IADL assesses the participant's ability to operate the telephone at baseline and end of treatment. Responses: ability to do the activity without help, some help, unable, or not done (missing). The percent of participants responding in the different levels of functional ability are provided.
- Symptom Score Associated With Treatment as Measured by the M.D. Anderson Symptom Inventory - LC(MDASI-LC) [Baseline and end of treatment (up to 20 cycles [14 months])]
The symptom score assessed: pain, fatigue, nausea, sleep, distress, shortness of breath, memory, appetite, drowsy, dry mouth, sadness, vomiting, numbness, cough, constipation, general activity, mood, work, relationships with other people, walking, enjoyment. Scores for each item range from 0 to 10, where 0 equaled no symptoms and 10 equaled worst possible symptoms. Assessed at baseline and end of treatment.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Non-small cell lung cancer (NSCLC) (any histologic type)
-
Stage IIIB or IV disease
-
Should have had 1 line of chemotherapy for Metastatic disease
-
Adequate hematologic, hepatic and renal function
-
Measurable or evaluable disease
Exclusion Criteria:
- Pregnant or lactating females
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Mobile | Alabama | United States | 36608 |
| 2 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Glendale | Arizona | United States | 85304 |
| 3 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Anaheim | California | United States | 92801 |
| 4 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Campbell | California | United States | 95008 |
| 5 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Daly City | California | United States | 94015 |
| 6 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | La Jolla | California | United States | 92093 |
| 7 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Lancaster | California | United States | 93534 |
| 8 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Mission Hills | California | United States | 91345 |
| 9 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Palo Alto | California | United States | 94305 |
| 10 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Poway | California | United States | 92064 |
| 11 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | San Diego | California | United States | 92123 |
| 12 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | San Francisco | California | United States | 94115 |
| 13 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | San Jose | California | United States | 95116 |
| 14 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Santa Cruz | California | United States | 95065 |
| 15 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Sunnyvale | California | United States | 94088 |
| 16 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Denver | Colorado | United States | 80209 |
| 17 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Greeley | Colorado | United States | 80631 |
| 18 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Stamford | Connecticut | United States | 06902 |
| 19 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Fort Lauderdale | Florida | United States | 33308 |
| 20 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Miami | Florida | United States | 33179 |
| 21 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Weston | Florida | United States | 33331 |
| 22 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Decatur | Georgia | United States | 30033 |
| 23 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Honolulu | Hawaii | United States | 96813 |
| 24 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Kealakekua | Hawaii | United States | 96750 |
| 25 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Morehead | Kentucky | United States | 40351 |
| 26 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | New Orleans | Louisiana | United States | 70121 |
| 27 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Omaha | Nebraska | United States | 68131 |
| 28 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Las Vegas | Nevada | United States | 89109 |
| 29 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Buffalo | New York | United States | 14263 |
| 30 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Washington | North Carolina | United States | 27889 |
| 31 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Memphis | Tennessee | United States | 38138 |
| 32 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Nashville | Tennessee | United States | 37203 |
| 33 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Corpus Christi | Texas | United States | 78463 |
| 34 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Galveston | Texas | United States | 77555 |
| 35 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Richardson | Texas | United States | 75080 |
| 36 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Monroe | Washington | United States | 98272 |
| 37 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Seattle | Washington | United States | 98133 |
| 38 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | San Juan | Puerto Rico | 00918 |
Sponsors and Collaborators
- Eli Lilly and Company
Investigators
- Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00497770
Other Study ID Numbers:
- 10733
- H3E-US-B001
First Posted:
Jul 9, 2007
Last Update Posted:
May 2, 2012
Last Verified:
Apr 1, 2012
Study Results
Participant Flow
| Recruitment Details | Target goals for recruitment were not met due to slow enrollment. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Caucasian | African American | Asian American | Hispanic |
|---|---|---|---|---|
| Arm/Group Description | Caucasian participants receiving pemetrexed for second (2nd) line non-small cell lung cancer (NSCLC) | African American participants receiving pemetrexed for 2nd line NSCLC | Asian American participants receiving pemetrexed for 2nd line NSCLC | Hispanic participants receiving pemetrexed for 2nd line NSCLC |
| Period Title: Overall Study | ||||
| STARTED | 304 | 65 | 37 | 28 |
| COMPLETED | 304 | 65 | 37 | 28 |
| NOT COMPLETED | 0 | 0 | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Caucasian | African American | Asian American | Hispanic | Total |
|---|---|---|---|---|---|
| Arm/Group Description | Caucasian participants receiving pemetrexed for second (2nd) line non-small cell lung cancer (NSCLC) | African American participants receiving pemetrexed for 2nd line NSCLC | Asian American participants receiving pemetrexed for 2nd line NSCLC | Hispanic participants receiving pemetrexed for 2nd line NSCLC | Total of all reporting groups |
| Overall Participants | 304 | 65 | 37 | 28 | 434 |
| Age (years) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [years] |
65.64
(9.94)
|
62.74
(8.93)
|
65.05
(11.31)
|
63.14
(13.29)
|
64.99
(10.19)
|
| Sex: Female, Male (Count of Participants) | |||||
| Female |
143
47%
|
22
33.8%
|
20
54.1%
|
14
50%
|
199
45.9%
|
| Male |
161
53%
|
43
66.2%
|
17
45.9%
|
14
50%
|
235
54.1%
|
| Region of Enrollment (participants) [Number] | |||||
| United States |
304
100%
|
65
100%
|
37
100%
|
28
100%
|
434
100%
|
| Disease Stage (participants) [Number] | |||||
| IIIB |
60
19.7%
|
14
21.5%
|
8
21.6%
|
8
28.6%
|
90
20.7%
|
| IV |
244
80.3%
|
51
78.5%
|
29
78.4%
|
20
71.4%
|
344
79.3%
|
| Histology of tumor (participants) [Number] | |||||
| Adenocarcinoma |
191
62.8%
|
44
67.7%
|
33
89.2%
|
25
89.3%
|
293
67.5%
|
| Squamous Cell |
77
25.3%
|
13
20%
|
2
5.4%
|
2
7.1%
|
94
21.7%
|
| Other [not adenocarcinoma or squamous cell] |
36
11.8%
|
8
12.3%
|
2
5.4%
|
1
3.6%
|
47
10.8%
|
| Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) (participants) [Number] | |||||
| 0 - Fully Active |
58
19.1%
|
15
23.1%
|
12
32.4%
|
8
28.6%
|
93
21.4%
|
| 1 - Ambulatory, Restricted Strenuous Activity |
166
54.6%
|
39
60%
|
15
40.5%
|
14
50%
|
234
53.9%
|
| 2 - Ambulatory, No Work Activities |
53
17.4%
|
7
10.8%
|
3
8.1%
|
2
7.1%
|
65
15%
|
| 3 - Partially Confined to Bed, Limited Self Care |
8
2.6%
|
1
1.5%
|
1
2.7%
|
1
3.6%
|
11
2.5%
|
| Not available |
19
6.3%
|
3
4.6%
|
6
16.2%
|
3
10.7%
|
31
7.1%
|
| Smoking Status (participants) [Number] | |||||
| Current |
83
27.3%
|
21
32.3%
|
0
0%
|
3
10.7%
|
107
24.7%
|
| Former |
196
64.5%
|
42
64.6%
|
13
35.1%
|
18
64.3%
|
269
62%
|
| Never |
21
6.9%
|
2
3.1%
|
24
64.9%
|
7
25%
|
54
12.4%
|
| Not Collected |
1
0.3%
|
0
0%
|
0
0%
|
0
0%
|
1
0.2%
|
| Unknown |
3
1%
|
0
0%
|
0
0%
|
0
0%
|
3
0.7%
|
Outcome Measures
| Title | Percentage of Participants With a Best Overall Disease Control Response (Disease Control Rate) |
|---|---|
| Description | Disease Control Rate [DCR] is the percentage of participants with Complete Response (CR), Partial Response (PR), Stable Disease (SD), and SD or Incomplete Response (SI). Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. CR=disappearance of all target lesions; PR=30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD)=20% increase in sum of longest diameter of target lesions; SD=small changes not meeting above criteria; SI=persistence of 1 or more non-target lesion(s) and/or maintenance of tumor marker level above normal limits. |
| Time Frame | baseline to measured progressive disease (up to 20 cycles [14 months]) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Of the 434 participants enrolled, 50 participants had a response status at the end of pemetrexed treatment indicating "Not done/Missing" and were not included in this analysis. |
| Arm/Group Title | Caucasian | African American | Asian American | Hispanic |
|---|---|---|---|---|
| Arm/Group Description | Caucasian participants receiving pemetrexed for 2nd line NSCLC | African American participants receiving pemetrexed for 2nd line NSCLC | Asian American participants receiving pemetrexed for 2nd line NSCLC | Hispanic participants receiving pemetrexed for 2nd line NSCLC |
| Measure Participants | 268 | 60 | 30 | 26 |
| Number [percentage of participants] |
43.7
14.4%
|
45.0
69.2%
|
53.33
144.1%
|
34.6
123.6%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Caucasian, African American |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | A pre-specified logistic regression was used to assess non-inferiority of DCR in African American participants compared with Caucasian participants. The DCR for African Americans was to be considered non-inferior to the DCR for Caucasians if the upper bound of the confidence interval (CI) of the odds ratio (OR) for African American versus Caucasian was <1.78 which corresponds to a difference in proportions of approximately 14% assuming the DCR in the reference group to be 50%. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 0.821 | |
| Confidence Interval |
(2-Sided) 95% 0.427 to 1.580 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Overall Survival |
|---|---|
| Description | Overall survival is the duration (months) from enrollment to death. For patients who are alive, overall survival is censored at the last contact. |
| Time Frame | baseline to date of death from any cause (up to 20 cycles [14 months]) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants enrolled in the study. |
| Arm/Group Title | Caucasian | African American | Asian American | Hispanic |
|---|---|---|---|---|
| Arm/Group Description | Caucasian participants receiving pemetrexed for 2nd line NSCLC | African American participants receiving pemetrexed for 2nd line NSCLC | Asian American participants receiving pemetrexed for 2nd line NSCLC | Hispanic participants receiving pemetrexed for 2nd line NSCLC |
| Measure Participants | 304 | 65 | 37 | 28 |
| Median (95% Confidence Interval) [months] |
6.77
(0.38)
|
6.90
(1.34)
|
16.0
(1.06)
|
5.35
(0.91)
|
| Title | Progression Free Survival |
|---|---|
| Description | Time from start of second line therapy until death, disease progression, or last contact expressed in months. Participants lost to follow-up (that were alive at last contact) were treated as censored using Kaplan-Meier survival analysis method. |
| Time Frame | baseline to measured progressive disease or death (up to 20 cycles [14 months]) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants enrolled in the study. |
| Arm/Group Title | Caucasian | African American | Asian American | Hispanic |
|---|---|---|---|---|
| Arm/Group Description | Caucasian participants receiving pemetrexed for second (2nd) line non-small cell lung cancer (NSCLC) | African American participants receiving pemetrexed for 2nd line NSCLC | Asian American participants receiving pemetrexed for 2nd line NSCLC | Hispanic participants receiving pemetrexed for 2nd line NSCLC |
| Measure Participants | 304 | 65 | 37 | 28 |
| Median (95% Confidence Interval) [months] |
2.66
|
2.99
|
5.08
|
2.20
|
| Title | Functional Status Based on Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to Plan and Prepare Meals |
|---|---|
| Description | The daily activities assessed: ability to plan and prepare meals. OARS-IADL assesses the participant's ability to plan and prepare meals at baseline and end of treatment. Responses: ability to do the activity without help, some help, unable, or not done (missing). The percent of participants responding in the different levels of functional ability are provided. |
| Time Frame | beginning and at end of pemetrexed treatment (up to 20 cycles [14 months]) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants enrolled in the study. |
| Arm/Group Title | Caucasian | African American | Asian American | Hispanic |
|---|---|---|---|---|
| Arm/Group Description | Caucasian participants receiving pemetrexed for 2nd line NSCLC | African American participants receiving pemetrexed for 2nd line NSCLC | Asian American participants receiving pemetrexed for 2nd line NSCLC | Hispanic participants receiving pemetrexed for 2nd line NSCLC |
| Measure Participants | 304 | 65 | 37 | 28 |
| Without Help-baseline |
63.2
20.8%
|
63.1
97.1%
|
70.3
190%
|
71.4
255%
|
| Some Help-baseline |
24.3
8%
|
23.1
35.5%
|
13.5
36.5%
|
10.7
38.2%
|
| Unable-baseline |
4.9
1.6%
|
9.2
14.2%
|
10.8
29.2%
|
17.9
63.9%
|
| Not Done (missing)-baseline |
7.6
2.5%
|
4.6
7.1%
|
5.4
14.6%
|
0.0
0%
|
| Without Help-end of treatment |
25.3
8.3%
|
26.2
40.3%
|
37.8
102.2%
|
14.3
51.1%
|
| Some Help-end of treatment |
9.5
3.1%
|
13.8
21.2%
|
8.1
21.9%
|
10.7
38.2%
|
| Unable-end of treatment |
4.3
1.4%
|
9.2
14.2%
|
0.0
0%
|
3.6
12.9%
|
| Not Done (missing)-end of treatment |
60.9
20%
|
50.8
78.2%
|
54.1
146.2%
|
71.4
255%
|
| Title | Functional Status Based on the Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to Drive or Use Public Transportation |
|---|---|
| Description | The daily activities assessed: ability to drive or use public transportation. OARS-IADL assesses the participant's ability to drive or use public transportation at baseline and end of treatment. Responses: ability to do the activity without help, some help, unable, or not done (missing). The percent of participants responding in the different levels of functional ability are provided. |
| Time Frame | beginning and at end of pemetrexed treatment (up to 20 cycles [14 months]) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants enrolled in the study. |
| Arm/Group Title | Caucasian | African American | Asian American | Hispanic |
|---|---|---|---|---|
| Arm/Group Description | Caucasian participants receiving pemetrexed for 2nd line NSCLC | African American participants receiving pemetrexed for 2nd line NSCLC | Asian American participants receiving pemetrexed for 2nd line NSCLC | Hispanic participants receiving pemetrexed for 2nd line NSCLC |
| Measure Participants | 304 | 65 | 37 | 28 |
| Without Help-baseline |
62.2
20.5%
|
63.1
97.1%
|
62.2
168.1%
|
50.0
178.6%
|
| Some Help-baseline |
29.6
9.7%
|
32.3
49.7%
|
29.7
80.3%
|
50.0
178.6%
|
| Unable-baseline |
0.7
0.2%
|
0.0
0%
|
2.7
7.3%
|
0.0
0%
|
| Not Done (missing)-baseline |
7.6
2.5%
|
4.6
7.1%
|
5.4
14.6%
|
0.0
0%
|
| Without Help-end of treatment |
23.4
7.7%
|
29.2
44.9%
|
45.9
124.1%
|
21.4
76.4%
|
| Some Help-end of treatment |
14.8
4.9%
|
20.0
30.8%
|
0.0
0%
|
7.1
25.4%
|
| Unable-end of treatment |
1.0
0.3%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
| Not Done (missing)-end of treatment |
60.9
20%
|
50.8
78.2%
|
54.1
146.2%
|
71.4
255%
|
| Title | Functional Status Based on the Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to Handle Personal Finances |
|---|---|
| Description | The daily activities assessed: ability to handle personal finances. OARS-IADL assesses the participant's ability to handle personal finances at baseline and end of treatment. Responses: ability to do the activity without help, some help, unable, or not done (missing). The percent of participants responding in the different levels of functional ability are provided. |
| Time Frame | beginning and at end of pemetrexed treatment (up to 20 cycles [14 months]) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants enrolled in the study. |
| Arm/Group Title | Caucasian | African American | Asian American | Hispanic |
|---|---|---|---|---|
| Arm/Group Description | Caucasian participants receiving pemetrexed for 2nd line NSCLC | African American participants receiving pemetrexed for 2nd line NSCLC | Asian American participants receiving pemetrexed for 2nd line NSCLC | Hispanic participants receiving pemetrexed for 2nd line NSCLC |
| Measure Participants | 304 | 65 | 37 | 28 |
| Without Help-baseline |
78.6
25.9%
|
67.7
104.2%
|
83.8
226.5%
|
71.4
255%
|
| Some Help-baseline |
11.5
3.8%
|
26.2
40.3%
|
8.1
21.9%
|
17.9
63.9%
|
| Unable-baseline |
2.3
0.8%
|
0.0
0%
|
2.7
7.3%
|
10.7
38.2%
|
| Not Done (missing)-baseline |
7.6
2.5%
|
6.2
9.5%
|
5.4
14.6%
|
0.0
0%
|
| Without Help-end of treatment |
31.9
10.5%
|
38.5
59.2%
|
45.9
124.1%
|
25.0
89.3%
|
| Some Help-end of treatment |
5.6
1.8%
|
10.8
16.6%
|
0.0
0%
|
3.6
12.9%
|
| Unable-end of treatment |
1.3
0.4%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
| Not Done (missing)-end of treatment |
61.2
20.1%
|
50.8
78.2%
|
54.1
146.2%
|
71.4
255%
|
| Title | Functional Status Based on the Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to Perform Housework Activities |
|---|---|
| Description | The daily activities assessed: ability to perform housework activities. OARS-IADL assesses the participant's ability to perform housework activities at baseline and end of treatment. Responses: ability to do the activity without help, some help, unable, or not done (missing). The percent of participants responding in the different levels of functional ability are provided. |
| Time Frame | beginning and at end of pemetrexed treatment (up to 20 cycles [14 months]) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants enrolled in the study. |
| Arm/Group Title | Caucasian | African American | Asian American | Hispanic |
|---|---|---|---|---|
| Arm/Group Description | Caucasian participants receiving pemetrexed for 2nd line NSCLC | African American participants receiving pemetrexed for 2nd line NSCLC | Asian American participants receiving pemetrexed for 2nd line NSCLC | Hispanic participants receiving pemetrexed for 2nd line NSCLC |
| Measure Participants | 304 | 65 | 37 | 28 |
| Without Help-baseline |
44.1
14.5%
|
44.6
68.6%
|
54.1
146.2%
|
42.9
153.2%
|
| Some Help-baseline |
38.2
12.6%
|
33.8
52%
|
32.4
87.6%
|
32.1
114.6%
|
| Unable-baseline |
9.5
3.1%
|
16.9
26%
|
8.1
21.9%
|
25.0
89.3%
|
| Not Done (missing)-baseline |
8.2
2.7%
|
4.6
7.1%
|
5.4
14.6%
|
0.0
0%
|
| Without Help-end of treatment |
15.8
5.2%
|
21.5
33.1%
|
27.0
73%
|
10.7
38.2%
|
| Some Help-end of treatment |
15.5
5.1%
|
18.5
28.5%
|
16.2
43.8%
|
14.3
51.1%
|
| Unable-end of treatment |
7.2
2.4%
|
9.2
14.2%
|
2.7
7.3%
|
3.6
12.9%
|
| Not Done (missing)-end of treatment |
61.5
20.2%
|
50.8
78.2%
|
54.1
146.2%
|
71.4
255%
|
| Title | Functional Status Based on the Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to Prepare and Take Medications |
|---|---|
| Description | The daily activities assessed: ability to prepare and take medications. OARS-IADL assesses the participant's ability to prepare and take medications at baseline and end of treatment. Responses: ability to do the activity without help, some help, unable, or not done (missing). The percent of participants responding in the different levels of functional ability are provided. |
| Time Frame | beginning and at end of pemetrexed treatment (up to 20 cycles [14 months]) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants enrolled in the study. |
| Arm/Group Title | Caucasian | African American | Asian American | Hispanic |
|---|---|---|---|---|
| Arm/Group Description | Caucasian participants receiving pemetrexed for 2nd line NSCLC | African American participants receiving pemetrexed for 2nd line NSCLC | Asian American participants receiving pemetrexed for 2nd line NSCLC | Hispanic participants receiving pemetrexed for 2nd line NSCLC |
| Measure Participants | 304 | 65 | 37 | 28 |
| Without Help-baseline |
79.3
26.1%
|
73.8
113.5%
|
86.5
233.8%
|
85.7
306.1%
|
| Some Help-baseline |
12.8
4.2%
|
21.5
33.1%
|
5.4
14.6%
|
7.1
25.4%
|
| Unable-baseline |
0.7
0.2%
|
0.0
0%
|
2.7
7.3%
|
7.1
25.4%
|
| Not Done (missing)-baseline |
7.2
2.4%
|
4.6
7.1%
|
5.4
14.6%
|
0.0
0%
|
| Without Help-end of treatment |
30.9
10.2%
|
36.9
56.8%
|
45.9
124.1%
|
25.0
89.3%
|
| Some Help-end of treatment |
7.6
2.5%
|
10.8
16.6%
|
0.0
0%
|
0.0
0%
|
| Unable-end of treatment |
0.7
0.2%
|
1.5
2.3%
|
0.0
0%
|
3.6
12.9%
|
| Not Done (missing)-end of treatment |
7.2
2.4%
|
4.6
7.1%
|
5.4
14.6%
|
0.0
0%
|
| Title | Functional Status Based on the Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to do the Act of Shopping |
|---|---|
| Description | The daily activities assessed: ability to do the act of shopping. OARS-IADL assesses the participant's ability to do the act of shopping at baseline and end of treatment. Responses: ability to do the activity without help, some help, unable, or not done (missing). The percent of participants responding in the different levels of functional ability are provided. |
| Time Frame | beginning and at end of pemetrexed treatment (up to 20 cycles [14 months]) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants enrolled in the study. |
| Arm/Group Title | Caucasian | African American | Asian American | Hispanic |
|---|---|---|---|---|
| Arm/Group Description | Caucasian participants receiving pemetrexed for 2nd line NSCLC | African American participants receiving pemetrexed for 2nd line NSCLC | Asian American participants receiving pemetrexed for 2nd line NSCLC | Hispanic participants receiving pemetrexed for 2nd line NSCLC |
| Measure Participants | 304 | 65 | 37 | 28 |
| Without Help-baseline |
57.2
18.8%
|
58.5
90%
|
59.5
160.8%
|
50.0
178.6%
|
| Some Help-baseline |
29.9
9.8%
|
32.3
49.7%
|
29.7
80.3%
|
35.7
127.5%
|
| Unable-baseline |
5.6
1.8%
|
4.6
7.1%
|
5.4
14.6%
|
14.3
51.1%
|
| Not Done (missing)-baseline |
7.2
2.4%
|
4.6
7.1%
|
5.4
14.6%
|
0.0
0%
|
| Without Help-end of treatment |
20.1
6.6%
|
24.6
37.8%
|
40.5
109.5%
|
14.3
51.1%
|
| Some Help-end of treatment |
14.1
4.6%
|
21.5
33.1%
|
5.4
14.6%
|
14.3
51.1%
|
| Unable-end of treatment |
4.6
1.5%
|
3.1
4.8%
|
0.0
0%
|
0.0
0%
|
| Not Done (missing)-end of treatment |
61.2
20.1%
|
50.8
78.2%
|
54.1
146.2%
|
71.4
255%
|
| Title | Functional Status Based on the Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to Operate the Telephone |
|---|---|
| Description | The daily activities assessed: ability to operate the telephone. OARS-IADL assesses the participant's ability to operate the telephone at baseline and end of treatment. Responses: ability to do the activity without help, some help, unable, or not done (missing). The percent of participants responding in the different levels of functional ability are provided. |
| Time Frame | beginning and at end of pemetrexed treatment (up to 20 cycles [14 months]) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants enrolled in the study. |
| Arm/Group Title | Caucasian | African American | Asian American | Hispanic |
|---|---|---|---|---|
| Arm/Group Description | Caucasian participants receiving pemetrexed for 2nd line NSCLC | African American participants receiving pemetrexed for 2nd line NSCLC | Asian American participants receiving pemetrexed for 2nd line NSCLC | Hispanic participants receiving pemetrexed for 2nd line NSCLC |
| Measure Participants | 304 | 65 | 37 | 28 |
| Without Help-baseline |
86.5
28.5%
|
90.8
139.7%
|
86.5
233.8%
|
92.9
331.8%
|
| Some Help-baseline |
5.6
1.8%
|
4.6
7.1%
|
5.4
14.6%
|
3.6
12.9%
|
| Unable-baseline |
0.0
0%
|
0.0
0%
|
2.7
7.3%
|
0.0
0%
|
| Not Done (missing)-baseline |
7.9
2.6%
|
4.6
7.1%
|
5.4
14.6%
|
3.6
12.9%
|
| Without Help-end of treatment |
34.9
11.5%
|
41.5
63.8%
|
45.9
124.1%
|
25.0
89.3%
|
| Some Help-end of treatment |
3.0
1%
|
7.7
11.8%
|
0.0
0%
|
3.6
12.9%
|
| Unable-end of treatment |
1.3
0.4%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
| Not Done (missing)-end of treatment |
60.9
20%
|
50.8
78.2%
|
54.1
146.2%
|
71.4
255%
|
| Title | Symptom Score Associated With Treatment as Measured by the M.D. Anderson Symptom Inventory - LC(MDASI-LC) |
|---|---|
| Description | The symptom score assessed: pain, fatigue, nausea, sleep, distress, shortness of breath, memory, appetite, drowsy, dry mouth, sadness, vomiting, numbness, cough, constipation, general activity, mood, work, relationships with other people, walking, enjoyment. Scores for each item range from 0 to 10, where 0 equaled no symptoms and 10 equaled worst possible symptoms. Assessed at baseline and end of treatment. |
| Time Frame | Baseline and end of treatment (up to 20 cycles [14 months]) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The number of participants who had measurements for the subscale at those time points. |
| Arm/Group Title | Caucasian | African American | Asian American | Hispanic |
|---|---|---|---|---|
| Arm/Group Description | Caucasian participants receiving pemetrexed for 2nd line NSCLC | African American participants receiving pemetrexed for 2nd line NSCLC | Asian American participants receiving pemetrexed for 2nd line NSCLC | Hispanic participants receiving pemetrexed for 2nd line NSCLC |
| Measure Participants | 282 | 65 | 35 | 28 |
| Pain-baseline (n=281, 62, 35, 28) |
3.37
(3.27)
1.1%
|
3.73
(3.63)
5.7%
|
3.89
(3.32)
10.5%
|
3.75
(3.95)
13.4%
|
| Pain-end of treatment (EOT) (n=118, 31, 17, 8) |
3.52
(3.25)
1.2%
|
5.16
(3.69)
7.9%
|
1.82
(2.30)
4.9%
|
1.88
(2.17)
6.7%
|
| Fatigue-baseline (n=279, 62, 35, 28) |
4.63
(2.83)
1.5%
|
4.58
(3.11)
7%
|
4.14
(2.37)
11.2%
|
5.04
(3.28)
18%
|
| Fatigue-EOT (n=119, 32, 17, 8) |
4.98
(2.72)
1.6%
|
4.91
(3.30)
7.6%
|
3.71
(2.76)
10%
|
4.00
(3.74)
14.3%
|
| Nausea-baseline (n=280, 62, 35, 28) |
1.39
(2.54)
0.5%
|
1.55
(2.60)
2.4%
|
1.34
(2.18)
3.6%
|
2.43
(3.49)
8.7%
|
| Nausea-EOT (n=118, 30, 17, 8) |
1.76
(2.67)
0.6%
|
1.67
(2.66)
2.6%
|
1.18
(1.33)
3.2%
|
0.75
(1.39)
2.7%
|
| Sleep-baseline (n=280, 62, 34, 28) |
3.24
(3.07)
1.1%
|
3.66
(3.59)
5.6%
|
3.21
(3.27)
8.7%
|
4.11
(2.97)
14.7%
|
| Sleep-EOT (n=118, 31, 17, 8) |
3.58
(2.97)
1.2%
|
4.16
(3.40)
6.4%
|
2.94
(3.27)
7.9%
|
3.13
(3.80)
11.2%
|
| Distress (Upset)-baseline (n=277, 62, 34, 28) |
2.89
(3.01)
1%
|
3.00
(3.23)
4.6%
|
2.76
(2.71)
7.5%
|
4.07
(3.57)
14.5%
|
| Distress (Upset)-EOT (n=119, 32, 17, 8) |
3.05
(2.94)
1%
|
3.22
(3.58)
5%
|
2.41
(1.97)
6.5%
|
3.63
(4.10)
13%
|
| Shortness of Breath-baseline (n=282, 61, 35, 28) |
3.58
(3.06)
1.2%
|
3.70
(3.12)
5.7%
|
2.69
(3.00)
7.3%
|
4.29
(3.40)
15.3%
|
| Shortness of Breath-EOT (n=118, 32, 17, 8) |
3.76
(3.12)
1.2%
|
5.06
(3.32)
7.8%
|
1.82
(2.53)
4.9%
|
2.88
(3.44)
10.3%
|
| Memory-baseline (n=278, 62, 35, 28) |
2.40
(2.56)
0.8%
|
2.71
(2.56)
4.2%
|
2.09
(2.31)
5.6%
|
2.50
(2.77)
8.9%
|
| Memory-EOT (n=119, 32, 17, 8) |
2.47
(2.56)
0.8%
|
2.81
(3.06)
4.3%
|
1.82
(2.38)
4.9%
|
0.63
(1.19)
2.3%
|
| Appetite-baseline (n=281, 62, 35, 28) |
2.84
(3.02)
0.9%
|
3.11
(3.38)
4.8%
|
3.37
(2.73)
9.1%
|
4.86
(3.30)
17.4%
|
| Appetite-EOT (n=119, 32, 16, 8) |
2.87
(3.01)
0.9%
|
4.72
(4.03)
7.3%
|
2.38
(2.58)
6.4%
|
4.00
(3.74)
14.3%
|
| Drowsy-baseline (n=280, 65, 32, 28) |
3.20
(2.79)
1.1%
|
3.32
(2.97)
5.1%
|
2.63
(2.38)
7.1%
|
4.36
(3.18)
15.6%
|
| Drowsy-EOT (n=119, 32, 17, 8) |
3.30
(2.84)
1.1%
|
3.69
(3.56)
5.7%
|
1.59
(1.84)
4.3%
|
3.13
(3.18)
11.2%
|
| Dry Mouth-baseline (n=279, 62, 35, 28) |
2.89
(2.98)
1%
|
2.73
(3.06)
4.2%
|
3.29
(3.19)
8.9%
|
3.36
(3.41)
12%
|
| Dry Mouth-EOT (n=119, 32, 17, 8) |
2.91
(2.99)
1%
|
2.44
(3.04)
3.8%
|
2.71
(2.78)
7.3%
|
2.25
(2.96)
8%
|
| Sadness-baseline (n=278, 61, 35, 28) |
2.40
(2.81)
0.8%
|
2.57
(3.23)
4%
|
2.74
(2.81)
7.4%
|
4.32
(3.51)
15.4%
|
| Sadness-EOT (n=119, 32, 17, 8) |
2.39
(2.83)
0.8%
|
2.81
(3.59)
4.3%
|
2.06
(2.08)
5.6%
|
3.88
(3.72)
13.9%
|
| Vomiting-baseline (n=282, 62, 35, 28) |
0.74
(1.85)
0.2%
|
0.97
(2.06)
1.5%
|
0.66
(1.35)
1.8%
|
1.25
(2.59)
4.5%
|
| Vomiting-EOT (n=119, 32, 17, 8) |
0.97
(1.49)
0.3%
|
1.06
(2.03)
1.6%
|
0.88
(2.03)
2.4%
|
0.13
(0.35)
0.5%
|
| Numbness-baseline (n=280, 61, 33, 28) |
2.42
(2.99)
0.8%
|
3.34
(3.26)
5.1%
|
2.76
(2.72)
7.5%
|
2.39
(3.40)
8.5%
|
| Numbness-EOT (n=119, 32, 17, 8) |
2.34
(2.64)
0.8%
|
3.84
(3.47)
5.9%
|
2.47
(2.15)
6.7%
|
0.63
(1.77)
2.3%
|
| Cough-baseline (n=281, 61, 35, 28) |
2.89
(2.92)
1%
|
2.98
(2.91)
4.6%
|
2.63
(2.77)
7.1%
|
2.61
(3.44)
9.3%
|
| Cough-EOT (n=119, 31, 16, 8) |
2.50
(2.63)
0.8%
|
3.94
(3.21)
6.1%
|
1.63
(1.96)
4.4%
|
3.13
(3.60)
11.2%
|
| Constipation-baseline (n=281, 62 34, 28) |
2.47
(3.11)
0.8%
|
2.37
(3.17)
3.6%
|
2.79
(3.22)
7.5%
|
3.54
(3.86)
12.6%
|
| Constipation-EOT (n=119, 32 17, 8) |
2.55
(2.85)
0.8%
|
2.88
(3.50)
4.4%
|
2.47
(3.10)
6.7%
|
1.50
(1.77)
5.4%
|
| General Activity-baseline (n=280, 62, 35, 28) |
3.71
(3.13)
1.2%
|
3.56
(3.38)
5.5%
|
2.46
(2.69)
6.6%
|
4.46
(3.89)
15.9%
|
| General Activity-EOT (n=119,32,16,8) |
3.89
(3.04)
1.3%
|
4.53
(3.65)
7%
|
2.88
(2.70)
7.8%
|
3.63
(3.50)
13%
|
| Mood-baseline (n=279, 61, 34, 28) |
2.85
(2.96)
0.9%
|
3.11
(3.07)
4.8%
|
2.44
(2.78)
6.6%
|
3.86
(3.76)
13.8%
|
| Mood-EOT (n=119, 32, 16, 8) |
2.07
(2.24)
0.7%
|
1.88
(2.23)
2.9%
|
1.89
(2.26)
5.1%
|
1.86
(2.97)
6.6%
|
| Work-baseline (n=278, 62, 35, 28) |
3.72
(3.32)
1.2%
|
4.23
(3.86)
6.5%
|
2.51
(2.45)
6.8%
|
4.86
(3.95)
17.4%
|
| Work-EOT (n=118, 32, 16, 8) |
4.05
(3.47)
1.3%
|
4.63
(3.72)
7.1%
|
2.81
(2.48)
7.6%
|
4.25
(3.77)
15.2%
|
| Relationships with Others-baseline(n=282,61,35,28) |
1.83
(2.53)
0.6%
|
2.41
(3.07)
3.7%
|
2.00
(2.52)
5.4%
|
3.07
(3.57)
11%
|
| Relationships with Others-EOT (n=118, 31, 16, 8) |
2.17
(2.76)
0.7%
|
2.71
(3.13)
4.2%
|
1.50
(2.31)
4.1%
|
2.75
(3.96)
9.8%
|
| Walking-baseline (n=280, 62, 35, 28) |
3.84
(3.15)
1.3%
|
4.00
(3.39)
6.2%
|
2.80
(2.75)
7.6%
|
4.21
(3.35)
15%
|
| Walking-EOT (n=119, 32, 16, 8) |
4.12
(3.32)
1.4%
|
4.44
(3.56)
6.8%
|
2.94
(2.54)
7.9%
|
4.00
(3.82)
14.3%
|
| Enjoyment-baseline (n=282, 61, 35, 28) |
3.33
(3.26)
1.1%
|
3.51
(3.38)
5.4%
|
2.83
(2.81)
7.6%
|
4.39
(4.04)
15.7%
|
| Enjoyment-EOT (n=119, 32, 16, 8) |
3.39
(3.16)
1.1%
|
4.00
(3.77)
6.2%
|
2.81
(2.54)
7.6%
|
4.00
(4.75)
14.3%
|
Adverse Events
| Time Frame | ||||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||
| Arm/Group Title | Caucasian | African American | Asian American | Hispanic | ||||
| Arm/Group Description | Caucasian participants receiving pemetrexed for second (2nd) line non-small cell lung cancer (NSCLC) | African American participants receiving pemetrexed for 2nd line NSCLC | Asian American participants receiving pemetrexed for 2nd line NSCLC | Hispanic participants receiving pemetrexed for 2nd line NSCLC | ||||
All Cause Mortality |
||||||||
| Caucasian | African American | Asian American | Hispanic | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||
Serious Adverse Events |
||||||||
| Caucasian | African American | Asian American | Hispanic | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 21/304 (6.9%) | 4/65 (6.2%) | 1/37 (2.7%) | 1/28 (3.6%) | ||||
| Blood and lymphatic system disorders | ||||||||
| Neutropenia | 8/304 (2.6%) | 10 | 1/65 (1.5%) | 1 | 0/37 (0%) | 0 | 1/28 (3.6%) | 1 |
| Thrombocytopenia | 7/304 (2.3%) | 8 | 1/65 (1.5%) | 1 | 0/37 (0%) | 0 | 0/28 (0%) | 0 |
| Gastrointestinal disorders | ||||||||
| Diarrhea | 1/304 (0.3%) | 1 | 0/65 (0%) | 0 | 0/37 (0%) | 0 | 0/28 (0%) | 0 |
| General disorders | ||||||||
| Fatigue | 11/304 (3.6%) | 12 | 3/65 (4.6%) | 3 | 1/37 (2.7%) | 1 | 0/28 (0%) | 0 |
| Mucositis | 0/304 (0%) | 0 | 1/65 (1.5%) | 1 | 0/37 (0%) | 0 | 0/28 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||||
| Caucasian | African American | Asian American | Hispanic | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 256/304 (84.2%) | 54/65 (83.1%) | 27/37 (73%) | 21/28 (75%) | ||||
| Blood and lymphatic system disorders | ||||||||
| Neutropenia | 55/304 (18.1%) | 76 | 9/65 (13.8%) | 13 | 2/37 (5.4%) | 3 | 3/28 (10.7%) | 4 |
| Thrombocytopenia | 55/304 (18.1%) | 84 | 6/65 (9.2%) | 10 | 2/37 (5.4%) | 4 | 4/28 (14.3%) | 4 |
| Gastrointestinal disorders | ||||||||
| Diarrhea | 45/304 (14.8%) | 59 | 5/65 (7.7%) | 6 | 2/37 (5.4%) | 2 | 2/28 (7.1%) | 4 |
| General disorders | ||||||||
| Fatigue | 242/304 (79.6%) | 516 | 52/65 (80%) | 108 | 27/37 (73%) | 57 | 21/28 (75%) | 37 |
| Mucositis | 22/304 (7.2%) | 25 | 9/65 (13.8%) | 12 | 2/37 (5.4%) | 2 | 1/28 (3.6%) | 1 |
| Skin and subcutaneous tissue disorders | ||||||||
| Alopecia | 55/304 (18.1%) | 79 | 5/65 (7.7%) | 7 | 2/37 (5.4%) | 3 | 3/28 (10.7%) | 6 |
Limitations/Caveats
This is an observational study, as such, the investigators followed the label recommendations and any changes to the label which occurred during the study.
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Chief Medical Officer |
|---|---|
| Organization | Eli Lilly and Company |
| Phone | 1-800-545-5979 |
Responsible Party:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00497770
Other Study ID Numbers:
- 10733
- H3E-US-B001
First Posted:
Jul 9, 2007
Last Update Posted:
May 2, 2012
Last Verified:
Apr 1, 2012