Trial Outcomes & Findings for A Trial for Patients With Advanced/Recurrent Endometrial Cancer (NCT NCT00377520)
NCT ID: NCT00377520
Last Updated: 2009-11-20
Results Overview
Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve ("respond"), stay the same ("stable"), or worsen ("progression") during treatment. Complete response (CR) = disappearance of all target lesions; Partial response (PR) = 30% decrease in the sum of the longest diameter of target lesions; Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions; Stable disease (SD) = small changes that do not meet above criteria.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
27 participants
Primary outcome timeframe
baseline to measured progressive disease (up to 24 months)
Results posted on
2009-11-20
Participant Flow
Participant milestones
| Measure |
Pemetrexed
900 mg/m2, intravenous (IV), every 21 days, until disease progression
|
|---|---|
|
Overall Study
STARTED
|
27
|
|
Overall Study
COMPLETED
|
26
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Pemetrexed
900 mg/m2, intravenous (IV), every 21 days, until disease progression
|
|---|---|
|
Overall Study
Ineligible (Prior radiation)
|
1
|
Baseline Characteristics
A Trial for Patients With Advanced/Recurrent Endometrial Cancer
Baseline characteristics by cohort
| Measure |
Pemetrexed
n=26 Participants
900 mg/m2, intravenous (IV), every 21 days, until disease progression
|
|---|---|
|
Age, Customized
40-49 years
|
3 participants
n=5 Participants
|
|
Age, Customized
50-59 years
|
6 participants
n=5 Participants
|
|
Age, Customized
60-69 years
|
10 participants
n=5 Participants
|
|
Age, Customized
>69 years
|
7 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
22 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
3 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
26 participants
n=5 Participants
|
|
Grade (Histology)
G1 - Well-Differentiated
|
5 participants
n=5 Participants
|
|
Grade (Histology)
G2 - Moderately Differentiated
|
8 participants
n=5 Participants
|
|
Grade (Histology)
G3 - Poorly Differentiated
|
13 participants
n=5 Participants
|
|
Gynecologic Oncology Group (GOG) Performance Status
0 - Fully active
|
14 participants
n=5 Participants
|
|
Gynecologic Oncology Group (GOG) Performance Status
1 - Ambulatory, Restricted Strenuous Activity
|
12 participants
n=5 Participants
|
|
Prior Treatment
Prior Chemotherapy
|
26 participants
n=5 Participants
|
|
Prior Treatment
No Prior Chemotherapy
|
0 participants
n=5 Participants
|
|
Prior Treatment
Prior Radiotherapy
|
12 participants
n=5 Participants
|
|
Prior Treatment
No Prior Radiotherapy
|
14 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline to measured progressive disease (up to 24 months)Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve ("respond"), stay the same ("stable"), or worsen ("progression") during treatment. Complete response (CR) = disappearance of all target lesions; Partial response (PR) = 30% decrease in the sum of the longest diameter of target lesions; Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions; Stable disease (SD) = small changes that do not meet above criteria.
Outcome measures
| Measure |
Pemetrexed
n=26 Participants
900 mg/m2, intravenous (IV), every 21 days, until disease progression
|
|---|---|
|
Tumor Response
Completed Response
|
0 participants
|
|
Tumor Response
Partial Response
|
1 participants
|
|
Tumor Response
Stable Disease
|
12 participants
|
|
Tumor Response
Progressive Disease
|
11 participants
|
|
Tumor Response
Inevaluable
|
2 participants
|
SECONDARY outcome
Timeframe: every 21-day cycle (up to 24 months)Adverse events were graded using the Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0) for defining and grading specific adverse events. A grading (severity) scale is provided for each adverse event term. Grades range from 0 (none) to 5 (death). The worst grade event per cycle is reported.
Outcome measures
| Measure |
Pemetrexed
n=26 Participants
900 mg/m2, intravenous (IV), every 21 days, until disease progression
|
|---|---|
|
Number of Participants With Adverse Events by Grade (Measures of Toxicity)
Constitutional - Grade 3
|
5 participants
|
|
Number of Participants With Adverse Events by Grade (Measures of Toxicity)
Constitutional - Grade 4
|
0 participants
|
|
Number of Participants With Adverse Events by Grade (Measures of Toxicity)
Leukopenia - Grade 1
|
3 participants
|
|
Number of Participants With Adverse Events by Grade (Measures of Toxicity)
Leukopenia - Grade 2
|
4 participants
|
|
Number of Participants With Adverse Events by Grade (Measures of Toxicity)
Leukopenia - Grade 3
|
8 participants
|
|
Number of Participants With Adverse Events by Grade (Measures of Toxicity)
Leukopenia - Grade 4
|
2 participants
|
|
Number of Participants With Adverse Events by Grade (Measures of Toxicity)
Thrombocytopenia - Grade 1
|
7 participants
|
|
Number of Participants With Adverse Events by Grade (Measures of Toxicity)
Thrombocytopenia - Grade 2
|
1 participants
|
|
Number of Participants With Adverse Events by Grade (Measures of Toxicity)
Thrombocytopenia - Grade 3
|
4 participants
|
|
Number of Participants With Adverse Events by Grade (Measures of Toxicity)
Thrombocytopenia - Grade 4
|
0 participants
|
|
Number of Participants With Adverse Events by Grade (Measures of Toxicity)
Neutropenia - Grade 1
|
2 participants
|
|
Number of Participants With Adverse Events by Grade (Measures of Toxicity)
Neutropenia - Grade 2
|
3 participants
|
|
Number of Participants With Adverse Events by Grade (Measures of Toxicity)
Neutropenia - Grade 3
|
9 participants
|
|
Number of Participants With Adverse Events by Grade (Measures of Toxicity)
Neutropenia - Grade 4
|
3 participants
|
|
Number of Participants With Adverse Events by Grade (Measures of Toxicity)
Anemia - Grade 1
|
9 participants
|
|
Number of Participants With Adverse Events by Grade (Measures of Toxicity)
Anemia - Grade 2
|
11 participants
|
|
Number of Participants With Adverse Events by Grade (Measures of Toxicity)
Anemia - Grade 3
|
5 participants
|
|
Number of Participants With Adverse Events by Grade (Measures of Toxicity)
Anemia - Grade 4
|
0 participants
|
|
Number of Participants With Adverse Events by Grade (Measures of Toxicity)
Coagulation - Grade 1
|
0 participants
|
|
Number of Participants With Adverse Events by Grade (Measures of Toxicity)
Coagulation - Grade 2
|
0 participants
|
|
Number of Participants With Adverse Events by Grade (Measures of Toxicity)
Coagulation - Grade 3
|
1 participants
|
|
Number of Participants With Adverse Events by Grade (Measures of Toxicity)
Coagulation - Grade 4
|
0 participants
|
|
Number of Participants With Adverse Events by Grade (Measures of Toxicity)
Nausea/vomiting - Grade 1
|
5 participants
|
|
Number of Participants With Adverse Events by Grade (Measures of Toxicity)
Nausea/vomiting - Grade 2
|
2 participants
|
|
Number of Participants With Adverse Events by Grade (Measures of Toxicity)
Nausea/vomiting - Grade 3
|
2 participants
|
|
Number of Participants With Adverse Events by Grade (Measures of Toxicity)
Nausea/vomiting - Grade 4
|
0 participants
|
|
Number of Participants With Adverse Events by Grade (Measures of Toxicity)
Gastrointestinal - Grade 1
|
6 participants
|
|
Number of Participants With Adverse Events by Grade (Measures of Toxicity)
Gastrointestinal - Grade 2
|
6 participants
|
|
Number of Participants With Adverse Events by Grade (Measures of Toxicity)
Gastrointestinal - Grade 3
|
3 participants
|
|
Number of Participants With Adverse Events by Grade (Measures of Toxicity)
Gastrointestinal - Grade 4
|
0 participants
|
|
Number of Participants With Adverse Events by Grade (Measures of Toxicity)
Alopecia - Grade 1
|
1 participants
|
|
Number of Participants With Adverse Events by Grade (Measures of Toxicity)
Alopecia - Grade 2
|
0 participants
|
|
Number of Participants With Adverse Events by Grade (Measures of Toxicity)
Dermatologic - Grade 1
|
4 participants
|
|
Number of Participants With Adverse Events by Grade (Measures of Toxicity)
Dermatologic - Grade 2
|
2 participants
|
|
Number of Participants With Adverse Events by Grade (Measures of Toxicity)
Dermatologic - Grade 3
|
1 participants
|
|
Number of Participants With Adverse Events by Grade (Measures of Toxicity)
Dermatologic - Grade 4
|
0 participants
|
|
Number of Participants With Adverse Events by Grade (Measures of Toxicity)
Alkaline phosphatase - Grade 1
|
4 participants
|
|
Number of Participants With Adverse Events by Grade (Measures of Toxicity)
Alkaline phosphatase - Grade 2
|
0 participants
|
|
Number of Participants With Adverse Events by Grade (Measures of Toxicity)
Alkaline phosphatase - Grade 3
|
0 participants
|
|
Number of Participants With Adverse Events by Grade (Measures of Toxicity)
Alkaline phosphatase - Grade 4
|
0 participants
|
|
Number of Participants With Adverse Events by Grade (Measures of Toxicity)
Serum glutamic-oxaloacetic transaminase - Grade 1
|
3 participants
|
|
Number of Participants With Adverse Events by Grade (Measures of Toxicity)
Serum glutamic-oxaloacetic transaminase - Grade 2
|
0 participants
|
|
Number of Participants With Adverse Events by Grade (Measures of Toxicity)
Serum glutamic-oxaloacetic transaminase - Grade 3
|
0 participants
|
|
Number of Participants With Adverse Events by Grade (Measures of Toxicity)
Serum glutamic-oxaloacetic transaminase - Grade 4
|
0 participants
|
|
Number of Participants With Adverse Events by Grade (Measures of Toxicity)
Neurologic - Grade 1
|
6 participants
|
|
Number of Participants With Adverse Events by Grade (Measures of Toxicity)
Neurologic - Grade 2
|
3 participants
|
|
Number of Participants With Adverse Events by Grade (Measures of Toxicity)
Neurologic - Grade 3
|
0 participants
|
|
Number of Participants With Adverse Events by Grade (Measures of Toxicity)
Neurologic - Grade 4
|
1 participants
|
|
Number of Participants With Adverse Events by Grade (Measures of Toxicity)
Infection - Grade 1
|
0 participants
|
|
Number of Participants With Adverse Events by Grade (Measures of Toxicity)
Infection - Grade 2
|
4 participants
|
|
Number of Participants With Adverse Events by Grade (Measures of Toxicity)
Infection - Grade 3
|
2 participants
|
|
Number of Participants With Adverse Events by Grade (Measures of Toxicity)
Infection - Grade 4
|
0 participants
|
|
Number of Participants With Adverse Events by Grade (Measures of Toxicity)
Pulmonary - Grade 1
|
2 participants
|
|
Number of Participants With Adverse Events by Grade (Measures of Toxicity)
Pulmonary - Grade 2
|
0 participants
|
|
Number of Participants With Adverse Events by Grade (Measures of Toxicity)
Pulmonary - Grade 3
|
0 participants
|
|
Number of Participants With Adverse Events by Grade (Measures of Toxicity)
Pulmonary - Grade 4
|
0 participants
|
|
Number of Participants With Adverse Events by Grade (Measures of Toxicity)
Metabolic - Grade 1
|
7 participants
|
|
Number of Participants With Adverse Events by Grade (Measures of Toxicity)
Metabolic - Grade 2
|
1 participants
|
|
Number of Participants With Adverse Events by Grade (Measures of Toxicity)
Metabolic - Grade 3
|
0 participants
|
|
Number of Participants With Adverse Events by Grade (Measures of Toxicity)
Metabolic - Grade 4
|
0 participants
|
|
Number of Participants With Adverse Events by Grade (Measures of Toxicity)
Lymphatics - Grade 1
|
3 participants
|
|
Number of Participants With Adverse Events by Grade (Measures of Toxicity)
Lymphatics - Grade 2
|
0 participants
|
|
Number of Participants With Adverse Events by Grade (Measures of Toxicity)
Lymphatics - Grade 3
|
1 participants
|
|
Number of Participants With Adverse Events by Grade (Measures of Toxicity)
Lymphatics - Grade 4
|
0 participants
|
|
Number of Participants With Adverse Events by Grade (Measures of Toxicity)
Pain - Grade 1
|
3 participants
|
|
Number of Participants With Adverse Events by Grade (Measures of Toxicity)
Pain - Grade 2
|
2 participants
|
|
Number of Participants With Adverse Events by Grade (Measures of Toxicity)
Pain - Grade 3
|
3 participants
|
|
Number of Participants With Adverse Events by Grade (Measures of Toxicity)
Pain - Grade 4
|
0 participants
|
|
Number of Participants With Adverse Events by Grade (Measures of Toxicity)
Constitutional - Grade 1
|
4 participants
|
|
Number of Participants With Adverse Events by Grade (Measures of Toxicity)
Constitutional - Grade 2
|
8 participants
|
|
Number of Participants With Adverse Events by Grade (Measures of Toxicity)
Renal - Grade 1
|
1 participants
|
|
Number of Participants With Adverse Events by Grade (Measures of Toxicity)
Renal - Grade 2
|
0 participants
|
|
Number of Participants With Adverse Events by Grade (Measures of Toxicity)
Renal - Grade 3
|
0 participants
|
|
Number of Participants With Adverse Events by Grade (Measures of Toxicity)
Renal - Grade 4
|
0 participants
|
|
Number of Participants With Adverse Events by Grade (Measures of Toxicity)
Musculoskeletal - Grade 1
|
1 participants
|
|
Number of Participants With Adverse Events by Grade (Measures of Toxicity)
Musculoskeletal - Grade 2
|
1 participants
|
|
Number of Participants With Adverse Events by Grade (Measures of Toxicity)
Musculoskeletal - Grade 3
|
0 participants
|
|
Number of Participants With Adverse Events by Grade (Measures of Toxicity)
Musculoskeletal - Grade 4
|
0 participants
|
|
Number of Participants With Adverse Events by Grade (Measures of Toxicity)
Ocular - Grade 1
|
2 participants
|
|
Number of Participants With Adverse Events by Grade (Measures of Toxicity)
Ocular - Grade 2
|
1 participants
|
|
Number of Participants With Adverse Events by Grade (Measures of Toxicity)
Ocular - Grade 3
|
0 participants
|
|
Number of Participants With Adverse Events by Grade (Measures of Toxicity)
Ocular - Grade 4
|
0 participants
|
|
Number of Participants With Adverse Events by Grade (Measures of Toxicity)
Cardiovascular - Grade 1
|
1 participants
|
|
Number of Participants With Adverse Events by Grade (Measures of Toxicity)
Cardiovascular - Grade 2
|
1 participants
|
|
Number of Participants With Adverse Events by Grade (Measures of Toxicity)
Cardiovascular - Grade 3
|
0 participants
|
|
Number of Participants With Adverse Events by Grade (Measures of Toxicity)
Cardiovascular - Grade 4
|
0 participants
|
|
Number of Participants With Adverse Events by Grade (Measures of Toxicity)
Vascular - Grade 1
|
0 participants
|
|
Number of Participants With Adverse Events by Grade (Measures of Toxicity)
Vascular - Grade 2
|
0 participants
|
|
Number of Participants With Adverse Events by Grade (Measures of Toxicity)
Vascular - Grade 3
|
1 participants
|
|
Number of Participants With Adverse Events by Grade (Measures of Toxicity)
Vascular - Grade 4
|
0 participants
|
|
Number of Participants With Adverse Events by Grade (Measures of Toxicity)
Endocrine - Grade 1
|
0 participants
|
|
Number of Participants With Adverse Events by Grade (Measures of Toxicity)
Endocrine - Grade 2
|
1 participants
|
|
Number of Participants With Adverse Events by Grade (Measures of Toxicity)
Endocrine - Grade 3
|
0 participants
|
|
Number of Participants With Adverse Events by Grade (Measures of Toxicity)
Endocrine - Grade 4
|
0 participants
|
Adverse Events
Pemetrexed
Serious events: 6 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pemetrexed
n=26 participants at risk
900 mg/m2, intravenous (IV), every 21 days, until disease progression
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
7.7%
2/26 • Number of events 2
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.8%
1/26 • Number of events 1
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.8%
1/26 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal fistula
|
3.8%
1/26 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
3.8%
1/26 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
3.8%
1/26 • Number of events 1
|
|
Nervous system disorders
Ataxia
|
3.8%
1/26 • Number of events 1
|
|
Nervous system disorders
Syncope
|
3.8%
1/26 • Number of events 1
|
|
Renal and urinary disorders
Renal failure acute
|
3.8%
1/26 • Number of events 1
|
Other adverse events
| Measure |
Pemetrexed
n=26 participants at risk
900 mg/m2, intravenous (IV), every 21 days, until disease progression
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
96.2%
25/26
|
|
Blood and lymphatic system disorders
Leukopenia
|
65.4%
17/26
|
|
Blood and lymphatic system disorders
Lymphatics
|
15.4%
4/26
|
|
Blood and lymphatic system disorders
Neutropenia
|
65.4%
17/26
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
46.2%
12/26
|
|
Cardiac disorders
Cardiovascular
|
7.7%
2/26
|
|
Eye disorders
Ocular
|
11.5%
3/26
|
|
Gastrointestinal disorders
Gastrointestinal
|
57.7%
15/26
|
|
Gastrointestinal disorders
Nausea/vomiting
|
34.6%
9/26
|
|
General disorders
Constitutional
|
65.4%
17/26
|
|
General disorders
Pain
|
30.8%
8/26
|
|
Infections and infestations
Infection
|
23.1%
6/26
|
|
Investigations
Alkaline phosphatase
|
15.4%
4/26
|
|
Investigations
Serum glutamic-oxaloacetic transaminase
|
11.5%
3/26
|
|
Metabolism and nutrition disorders
Metabolic
|
30.8%
8/26
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal
|
7.7%
2/26
|
|
Nervous system disorders
Neurologic
|
38.5%
10/26
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary
|
7.7%
2/26
|
|
Skin and subcutaneous tissue disorders
Dermatologic
|
26.9%
7/26
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 1-800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60