Trial Outcomes & Findings for A Study of Single Agent Pemetrexed Disodium in Treating Patients With Recurrent or Persistent Ovarian or Primary Peritoneal Cancer (NCT NCT00461786)
NCT ID: NCT00461786
Last Updated: 2009-12-04
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
51 participants
Primary outcome timeframe
baseline to measured progressive disease (up to 44 months)
Results posted on
2009-12-04
Participant Flow
Participant milestones
| Measure |
Pemetrexed
Pemetrexed 900 mg/m2, intravenous (IV), every 21 days, until disease progression
|
|---|---|
|
Overall Study
STARTED
|
51
|
|
Overall Study
COMPLETED
|
48
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Pemetrexed
Pemetrexed 900 mg/m2, intravenous (IV), every 21 days, until disease progression
|
|---|---|
|
Overall Study
Entry Criteria Not Met
|
2
|
|
Overall Study
Inevaluable (Never Treated)
|
1
|
Baseline Characteristics
A Study of Single Agent Pemetrexed Disodium in Treating Patients With Recurrent or Persistent Ovarian or Primary Peritoneal Cancer
Baseline characteristics by cohort
| Measure |
Pemetrexed
n=48 Participants
Pemetrexed 900 mg/m2, intravenous (IV), every 21 days, until disease progression
|
|---|---|
|
Age, Customized
<40 years
|
1 participants
n=5 Participants
|
|
Age, Customized
40-49 years
|
6 participants
n=5 Participants
|
|
Age, Customized
50-59 years
|
14 participants
n=5 Participants
|
|
Age, Customized
60-69 years
|
14 participants
n=5 Participants
|
|
Age, Customized
70-79 years
|
11 participants
n=5 Participants
|
|
Age, Customized
>79 years
|
2 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
48 participants
n=5 Participants
|
|
Cell Type
Serous
|
34 participants
n=5 Participants
|
|
Cell Type
Clear Cell
|
5 participants
n=5 Participants
|
|
Cell Type
Mixed Epithelial
|
6 participants
n=5 Participants
|
|
Cell Type
Endometrioid
|
1 participants
n=5 Participants
|
|
Cell Type
Adenocarcinoma, Unspecified
|
1 participants
n=5 Participants
|
|
Cell Type
Undifferentiated Carcinoma
|
1 participants
n=5 Participants
|
|
Gynecologic Oncology Group Performance Status
0 - Fully active
|
30 participants
n=5 Participants
|
|
Gynecologic Oncology Group Performance Status
1 - Ambulatory, Restricted Strenuous Activity
|
15 participants
n=5 Participants
|
|
Gynecologic Oncology Group Performance Status
2 - Ambulatory, No Work Activities
|
3 participants
n=5 Participants
|
|
Prior Chemotherapy
Yes
|
48 participants
n=5 Participants
|
|
Prior Chemotherapy
No
|
0 participants
n=5 Participants
|
|
Prior Radiotherapy
Yes
|
1 participants
n=5 Participants
|
|
Prior Radiotherapy
No
|
47 participants
n=5 Participants
|
|
Race/Ethnicity
White
|
47 participants
n=5 Participants
|
|
Race/Ethnicity
Black
|
1 participants
n=5 Participants
|
|
Tumor Grade
1 - Well-Differentiated
|
1 participants
n=5 Participants
|
|
Tumor Grade
2 - Moderately Differentiated
|
15 participants
n=5 Participants
|
|
Tumor Grade
3 - Poorly Differentiated
|
31 participants
n=5 Participants
|
|
Tumor Grade
Unspecified
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline to measured progressive disease (up to 44 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=48 Participants
Pemetrexed 900 mg/m2, intravenous (IV), every 21 days, until disease progression
|
|---|---|
|
Tumor Response
Complete Response
|
1 participants
|
|
Tumor Response
Partial Response
|
9 participants
|
|
Tumor Response
Stable Disease
|
17 participants
|
|
Tumor Response
Progressive Disease
|
18 participants
|
|
Tumor Response
Inevaluable
|
3 participants
|
SECONDARY outcome
Timeframe: every 21-day cycle up to 5 year follow-upAdverse 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=48 Participants
Pemetrexed 900 mg/m2, intravenous (IV), every 21 days, until disease progression
|
|---|---|
|
Number of Participants With Adverse Events by Grade
Nausea/vomiting - Grade 3
|
4 participants
|
|
Number of Participants With Adverse Events by Grade
Nausea/vomiting - Grade 4
|
0 participants
|
|
Number of Participants With Adverse Events by Grade
Genitourinary - Grade 1
|
4 participants
|
|
Number of Participants With Adverse Events by Grade
Genitourinary - Grade 2
|
0 participants
|
|
Number of Participants With Adverse Events by Grade
Genitourinary - Grade 3
|
2 participants
|
|
Number of Participants With Adverse Events by Grade
Genitourinary - Grade 4
|
0 participants
|
|
Number of Participants With Adverse Events by Grade
Hepatic - Grade 1
|
2 participants
|
|
Number of Participants With Adverse Events by Grade
Hepatic - Grade 2
|
2 participants
|
|
Number of Participants With Adverse Events by Grade
Hepatic - Grade 3
|
1 participants
|
|
Number of Participants With Adverse Events by Grade
Hepatic - Grade 4
|
0 participants
|
|
Number of Participants With Adverse Events by Grade
Alopecia - Grade 1
|
7 participants
|
|
Number of Participants With Adverse Events by Grade
Alopecia - Grade 2
|
5 participants
|
|
Number of Participants With Adverse Events by Grade
Dermatologic - Grade 1
|
10 participants
|
|
Number of Participants With Adverse Events by Grade
Dermatologic - Grade 2
|
10 participants
|
|
Number of Participants With Adverse Events by Grade
Dermatologic - Grade 3
|
3 participants
|
|
Number of Participants With Adverse Events by Grade
Dermatologic - Grade 4
|
0 participants
|
|
Number of Participants With Adverse Events by Grade
Neurologic - Grade 1
|
12 participants
|
|
Number of Participants With Adverse Events by Grade
Neurologic - Grade 2
|
1 participants
|
|
Number of Participants With Adverse Events by Grade
Neurologic - Grade 3
|
4 participants
|
|
Number of Participants With Adverse Events by Grade
Neurologic - Grade 4
|
1 participants
|
|
Number of Participants With Adverse Events by Grade
SGOT - Grade 1
|
9 participants
|
|
Number of Participants With Adverse Events by Grade
SGOT - Grade 2
|
4 participants
|
|
Number of Participants With Adverse Events by Grade
SGOT - Grade 3
|
0 participants
|
|
Number of Participants With Adverse Events by Grade
SGOT - Grade 4
|
0 participants
|
|
Number of Participants With Adverse Events by Grade
Alkaline phosphatase - Grade 1
|
3 participants
|
|
Number of Participants With Adverse Events by Grade
Alkaline phosphatase - Grade 2
|
3 participants
|
|
Number of Participants With Adverse Events by Grade
Alkaline phosphatase - Grade 3
|
0 participants
|
|
Number of Participants With Adverse Events by Grade
Alkaline phosphatase - Grade 4
|
0 participants
|
|
Number of Participants With Adverse Events by Grade
Ocular - Grade 1
|
2 participants
|
|
Number of Participants With Adverse Events by Grade
Ocular - Grade 2
|
3 participants
|
|
Number of Participants With Adverse Events by Grade
Ocular - Grade 3
|
1 participants
|
|
Number of Participants With Adverse Events by Grade
Ocular - Grade 4
|
0 participants
|
|
Number of Participants With Adverse Events by Grade
Hemorrhage - Grade 1
|
2 participants
|
|
Number of Participants With Adverse Events by Grade
Hemorrhage - Grade 2
|
0 participants
|
|
Number of Participants With Adverse Events by Grade
Hemorrhage - Grade 3
|
1 participants
|
|
Number of Participants With Adverse Events by Grade
Hemorrhage - Grade 4
|
0 participants
|
|
Number of Participants With Adverse Events by Grade
Pulmonary - Grade 1
|
4 participants
|
|
Number of Participants With Adverse Events by Grade
Pulmonary - Grade 2
|
1 participants
|
|
Number of Participants With Adverse Events by Grade
Pulmonary - Grade 3
|
0 participants
|
|
Number of Participants With Adverse Events by Grade
Pulmonary - Grade 4
|
0 participants
|
|
Number of Participants With Adverse Events by Grade
Lymphopenia - Grade 1
|
1 participants
|
|
Number of Participants With Adverse Events by Grade
Lymphopenia - Grade 2
|
0 participants
|
|
Number of Participants With Adverse Events by Grade
Lymphopenia - Grade 3
|
0 participants
|
|
Number of Participants With Adverse Events by Grade
Lymphopenia - Grade 4
|
0 participants
|
|
Number of Participants With Adverse Events by Grade
Constitutional - Grade 1
|
17 participants
|
|
Number of Participants With Adverse Events by Grade
Constitutional - Grade 2
|
14 participants
|
|
Number of Participants With Adverse Events by Grade
Constitutional - Grade 3
|
5 participants
|
|
Number of Participants With Adverse Events by Grade
Constitutional - Grade 4
|
2 participants
|
|
Number of Participants With Adverse Events by Grade
Metabolic - Grade 1
|
20 participants
|
|
Number of Participants With Adverse Events by Grade
Metabolic - Grade 2
|
9 participants
|
|
Number of Participants With Adverse Events by Grade
Metabolic - Grade 3
|
4 participants
|
|
Number of Participants With Adverse Events by Grade
Metabolic - Grade 4
|
0 participants
|
|
Number of Participants With Adverse Events by Grade
Cardiovascular - Grade 1
|
3 participants
|
|
Number of Participants With Adverse Events by Grade
Cardiovascular - Grade 2
|
0 participants
|
|
Number of Participants With Adverse Events by Grade
Cardiovascular - Grade 3
|
0 participants
|
|
Number of Participants With Adverse Events by Grade
Cardiovascular - Grade 4
|
0 participants
|
|
Number of Participants With Adverse Events by Grade
Pain - Grade 1
|
8 participants
|
|
Number of Participants With Adverse Events by Grade
Pain - Grade 2
|
6 participants
|
|
Number of Participants With Adverse Events by Grade
Pain - Grade 3
|
1 participants
|
|
Number of Participants With Adverse Events by Grade
Pain - Grade 4
|
1 participants
|
|
Number of Participants With Adverse Events by Grade
Infection - Grade 1
|
2 participants
|
|
Number of Participants With Adverse Events by Grade
Infection - Grade 2
|
5 participants
|
|
Number of Participants With Adverse Events by Grade
Infection - Grade 3
|
5 participants
|
|
Number of Participants With Adverse Events by Grade
Infection - Grade 4
|
0 participants
|
|
Number of Participants With Adverse Events by Grade
Auditory - Grade 1
|
0 participants
|
|
Number of Participants With Adverse Events by Grade
Auditory - Grade 2
|
2 participants
|
|
Number of Participants With Adverse Events by Grade
Auditory - Grade 3
|
1 participants
|
|
Number of Participants With Adverse Events by Grade
Auditory - Grade 4
|
0 participants
|
|
Number of Participants With Adverse Events by Grade
Lymphatics - Grade 1
|
4 participants
|
|
Number of Participants With Adverse Events by Grade
Lymphatics - Grade 2
|
1 participants
|
|
Number of Participants With Adverse Events by Grade
Lymphatics - Grade 3
|
0 participants
|
|
Number of Participants With Adverse Events by Grade
Lymphatics - Grade 4
|
1 participants
|
|
Number of Participants With Adverse Events by Grade
Endocrine - Grade 1
|
2 participants
|
|
Number of Participants With Adverse Events by Grade
Endocrine - Grade 2
|
0 participants
|
|
Number of Participants With Adverse Events by Grade
Endocrine - Grade 3
|
0 participants
|
|
Number of Participants With Adverse Events by Grade
Endocrine - Grade 4
|
0 participants
|
|
Number of Participants With Adverse Events by Grade
Allergy - Grade 1
|
0 participants
|
|
Number of Participants With Adverse Events by Grade
Allergy - Grade 2
|
1 participants
|
|
Number of Participants With Adverse Events by Grade
Allergy - Grade 3
|
0 participants
|
|
Number of Participants With Adverse Events by Grade
Allergy - Grade 4
|
0 participants
|
|
Number of Participants With Adverse Events by Grade
Leukopenia - Grade 1
|
11 participants
|
|
Number of Participants With Adverse Events by Grade
Leukopenia - Grade 2
|
13 participants
|
|
Number of Participants With Adverse Events by Grade
Leukopenia - Grade 3
|
11 participants
|
|
Number of Participants With Adverse Events by Grade
Leukopenia - Grade 4
|
1 participants
|
|
Number of Participants With Adverse Events by Grade
Thrombocytopenia - Grade 1
|
15 participants
|
|
Number of Participants With Adverse Events by Grade
Thrombocytopenia - Grade 2
|
5 participants
|
|
Number of Participants With Adverse Events by Grade
Thrombocytopenia - Grade 3
|
2 participants
|
|
Number of Participants With Adverse Events by Grade
Thrombocytopenia - Grade 4
|
4 participants
|
|
Number of Participants With Adverse Events by Grade
Neutropenia - Grade 1
|
9 participants
|
|
Number of Participants With Adverse Events by Grade
Neutropenia - Grade 2
|
6 participants
|
|
Number of Participants With Adverse Events by Grade
Neutropenia - Grade 3
|
11 participants
|
|
Number of Participants With Adverse Events by Grade
Neutropenia - Grade 4
|
9 participants
|
|
Number of Participants With Adverse Events by Grade
Anemia - Grade 1
|
14 participants
|
|
Number of Participants With Adverse Events by Grade
Anemia - Grade 2
|
17 participants
|
|
Number of Participants With Adverse Events by Grade
Anemia - Grade 3
|
7 participants
|
|
Number of Participants With Adverse Events by Grade
Anemia - Grade 4
|
0 participants
|
|
Number of Participants With Adverse Events by Grade
Transfusion - Grade 1
|
0 participants
|
|
Number of Participants With Adverse Events by Grade
Transfusion - Grade 2
|
1 participants
|
|
Number of Participants With Adverse Events by Grade
Transfusion - Grade 3
|
0 participants
|
|
Number of Participants With Adverse Events by Grade
Transfusion - Grade 4
|
0 participants
|
|
Number of Participants With Adverse Events by Grade
Coagulation - Grade 1
|
0 participants
|
|
Number of Participants With Adverse Events by Grade
Coagulation - Grade 2
|
1 participants
|
|
Number of Participants With Adverse Events by Grade
Coagulation - Grade 3
|
0 participants
|
|
Number of Participants With Adverse Events by Grade
Coagulation - Grade 4
|
0 participants
|
|
Number of Participants With Adverse Events by Grade
Gastrointestinal - Grade 1
|
14 participants
|
|
Number of Participants With Adverse Events by Grade
Gastrointestinal - Grade 2
|
14 participants
|
|
Number of Participants With Adverse Events by Grade
Gastrointestinal - Grade 3
|
4 participants
|
|
Number of Participants With Adverse Events by Grade
Gastrointestinal - Grade 4
|
0 participants
|
|
Number of Participants With Adverse Events by Grade
Nausea/vomiting - Grade 1
|
15 participants
|
|
Number of Participants With Adverse Events by Grade
Nausea/vomiting - Grade 2
|
7 participants
|
SECONDARY outcome
Timeframe: time of initial response until documented tumor progression (up to 44 months)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 or death as a result of any cause.
Outcome measures
| Measure |
Pemetrexed
n=48 Participants
Pemetrexed 900 mg/m2, intravenous (IV), every 21 days, until disease progression
|
|---|---|
|
Duration of Response
|
8.4 months
Interval 2.8 to 30.4
|
SECONDARY outcome
Timeframe: baseline until documented tumor progression (up to 44 months)Defined as the time from date of first dose to the first observation of disease progression, or death due to any cause.
Outcome measures
| Measure |
Pemetrexed
n=48 Participants
Pemetrexed 900 mg/m2, intravenous (IV), every 21 days, until disease progression
|
|---|---|
|
Progression-Free Survival
|
3.0 months
Interval 1.0 to 33.1
|
SECONDARY outcome
Timeframe: baseline until death from any cause up to 5-year follow-upOverall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact.
Outcome measures
| Measure |
Pemetrexed
n=48 Participants
Pemetrexed 900 mg/m2, intravenous (IV), every 21 days, until disease progression
|
|---|---|
|
Overall Survival
|
11.4 months
Interval 1.6 to 34.4
|
Adverse Events
Pemetrexed
Serious events: 12 serious events
Other events: 47 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pemetrexed
n=48 participants at risk
Pemetrexed 900 mg/m2, intravenous (IV), every 21 days, until disease progression
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.1%
1/48 • Number of events 1
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
4.2%
2/48 • Number of events 3
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.1%
1/48 • Number of events 2
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
4.2%
2/48 • Number of events 2
|
|
Cardiac disorders
Atrial fibrillation
|
2.1%
1/48 • Number of events 1
|
|
Ear and labyrinth disorders
Vertigo
|
2.1%
1/48 • Number of events 1
|
|
Gastrointestinal disorders
Ileus
|
2.1%
1/48 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
4.2%
2/48 • Number of events 3
|
|
Gastrointestinal disorders
Vomiting
|
6.2%
3/48 • Number of events 4
|
|
General disorders
Asthenia
|
2.1%
1/48 • Number of events 1
|
|
General disorders
Generalised oedema
|
2.1%
1/48 • Number of events 1
|
|
General disorders
Pyrexia
|
4.2%
2/48 • Number of events 2
|
|
Immune system disorders
Anaphylactic reaction
|
2.1%
1/48 • Number of events 1
|
|
Infections and infestations
Cellulitis
|
2.1%
1/48 • Number of events 1
|
|
Infections and infestations
Infection
|
2.1%
1/48 • Number of events 1
|
|
Infections and infestations
Pyelonephritis
|
2.1%
1/48 • Number of events 1
|
|
Investigations
Blood alkaline phosphatase increased
|
2.1%
1/48 • Number of events 1
|
|
Investigations
Blood creatinine abnormal
|
2.1%
1/48 • Number of events 1
|
|
Investigations
Blood creatinine increased
|
2.1%
1/48 • Number of events 1
|
|
Investigations
Glomerular filtration rate decreased
|
2.1%
1/48 • Number of events 1
|
|
Metabolism and nutrition disorders
Anorexia
|
2.1%
1/48 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
6.2%
3/48 • Number of events 3
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
2.1%
1/48 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
2.1%
1/48 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
2.1%
1/48 • Number of events 1
|
|
Psychiatric disorders
Confusional state
|
2.1%
1/48 • Number of events 1
|
|
Renal and urinary disorders
Pelvi-ureteric obstruction
|
2.1%
1/48 • Number of events 1
|
|
Renal and urinary disorders
Renal failure
|
2.1%
1/48 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.1%
1/48 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.1%
1/48 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
2.1%
1/48 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.2%
2/48 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
4.2%
2/48 • Number of events 2
|
|
Vascular disorders
Hypotension
|
2.1%
1/48 • Number of events 1
|
Other adverse events
| Measure |
Pemetrexed
n=48 participants at risk
Pemetrexed 900 mg/m2, intravenous (IV), every 21 days, until disease progression
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
79.2%
38/48
|
|
Blood and lymphatic system disorders
Leukopenia
|
75.0%
36/48
|
|
Blood and lymphatic system disorders
Lymphatics
|
12.5%
6/48
|
|
Blood and lymphatic system disorders
Neutropenia
|
72.9%
35/48
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
54.2%
26/48
|
|
Cardiac disorders
Cardiovascular
|
6.2%
3/48
|
|
Ear and labyrinth disorders
Auditory
|
6.2%
3/48
|
|
Eye disorders
Ocular
|
12.5%
6/48
|
|
Gastrointestinal disorders
Gastrointestinal
|
66.7%
32/48
|
|
Gastrointestinal disorders
Nausea/vomiting
|
54.2%
26/48
|
|
General disorders
Constitutional
|
79.2%
38/48
|
|
General disorders
Pain
|
33.3%
16/48
|
|
Hepatobiliary disorders
Hepatic
|
10.4%
5/48
|
|
Infections and infestations
Infection
|
25.0%
12/48
|
|
Investigations
Alkaline phosphatase
|
12.5%
6/48
|
|
Investigations
Serum glutamic oxaloacetic transaminase
|
27.1%
13/48
|
|
Metabolism and nutrition disorders
Metabolic
|
68.8%
33/48
|
|
Nervous system disorders
Neurologic
|
37.5%
18/48
|
|
Renal and urinary disorders
Genitourinary
|
12.5%
6/48
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary
|
10.4%
5/48
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
25.0%
12/48
|
|
Skin and subcutaneous tissue disorders
Dermatologic
|
47.9%
23/48
|
|
Vascular disorders
Hemorrhage
|
6.2%
3/48
|
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