Trial Outcomes & Findings for Trial of Pemetrexed and Bevacizumab for Recurrent Ovarian Primary Peritoneal Carcinoma (NCT NCT00868192)
NCT ID: NCT00868192
Last Updated: 2014-10-20
Results Overview
PFS = Period from study entry until disease progression, death, or date of last contact
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
38 participants
Primary outcome timeframe
6 months
Results posted on
2014-10-20
Participant Flow
The study was open to participant enrollment on 05/28/2008 and closed to participant enrollment on 11/30/2010.
Participant milestones
| Measure |
Pemetrexed and Bevacizumab
Pemetrexed 500 mg/m2 IV on Day 1 of each 21 day cycle
Bevacizumab 15 mg/kg IV on Day 1 of each 21 day cycle
|
|---|---|
|
Overall Study
STARTED
|
38
|
|
Overall Study
COMPLETED
|
34
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Pemetrexed and Bevacizumab
Pemetrexed 500 mg/m2 IV on Day 1 of each 21 day cycle
Bevacizumab 15 mg/kg IV on Day 1 of each 21 day cycle
|
|---|---|
|
Overall Study
Ineligible
|
4
|
Baseline Characteristics
Trial of Pemetrexed and Bevacizumab for Recurrent Ovarian Primary Peritoneal Carcinoma
Baseline characteristics by cohort
| Measure |
Pemetrexed and Bevacizumab
n=34 Participants
Pemetrexed 500 mg/m2 IV on Day 1 of each 21 day cycle
Bevacizumab 15 mg/kg IV on Day 1 of each 21 day cycle
|
|---|---|
|
Age, Continuous
|
61.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
34 participants
n=5 Participants
|
|
Stage
Stage I/II
|
1 participants
n=5 Participants
|
|
Stage
Stage III
|
27 participants
n=5 Participants
|
|
Stage
Stage IV
|
6 participants
n=5 Participants
|
|
Histology
Serous
|
24 participants
n=5 Participants
|
|
Histology
Endometriod
|
2 participants
n=5 Participants
|
|
Histology
Mixed
|
3 participants
n=5 Participants
|
|
Histology
Other
|
5 participants
n=5 Participants
|
|
Tumor grade
Grade 1
|
3 participants
n=5 Participants
|
|
Tumor grade
Grade 2
|
1 participants
n=5 Participants
|
|
Tumor grade
Grade 3
|
30 participants
n=5 Participants
|
|
Pathologic diagnosis
Ovarian
|
27 participants
n=5 Participants
|
|
Pathologic diagnosis
Fallopian tube
|
1 participants
n=5 Participants
|
|
Pathologic diagnosis
Primary peritoneal
|
6 participants
n=5 Participants
|
|
Gynecologic Oncology Group (GOG) Performance Status
0
|
22 participants
n=5 Participants
|
|
Gynecologic Oncology Group (GOG) Performance Status
1
|
12 participants
n=5 Participants
|
|
Prior number of chemotherapy regimens
1
|
20 participants
n=5 Participants
|
|
Prior number of chemotherapy regimens
2
|
14 participants
n=5 Participants
|
|
Platinum-free interval
<6 months
|
12 participants
n=5 Participants
|
|
Platinum-free interval
6-12 months
|
11 participants
n=5 Participants
|
|
Platinum-free interval
>12 months
|
11 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPFS = Period from study entry until disease progression, death, or date of last contact
Outcome measures
| Measure |
Pemetrexed and Bevacizumab
n=34 Participants
Pemetrexed 500 mg/m2 IV on Day 1 of each 21 day cycle
Bevacizumab 15 mg/kg IV on Day 1 of each 21 day cycle
|
|---|---|
|
Progression-free Survival (PFS)
|
56 percentage of participants
Interval 38.0 to 71.0
|
SECONDARY outcome
Timeframe: Median follow-up was 25.7 months (range 3.0-47.2 months)PFS = Period from study entry until disease progression, death, or date of last contact
Outcome measures
| Measure |
Pemetrexed and Bevacizumab
n=34 Participants
Pemetrexed 500 mg/m2 IV on Day 1 of each 21 day cycle
Bevacizumab 15 mg/kg IV on Day 1 of each 21 day cycle
|
|---|---|
|
Distribution of Progression-free Survival (PFS)
Platinum-free interval of <6 months
|
6.7 months
Interval 4.1 to 9.9
|
|
Distribution of Progression-free Survival (PFS)
Platinum-free interval of 6-12 months
|
4.7 months
Interval 2.8 to 8.4
|
|
Distribution of Progression-free Survival (PFS)
Platinum-free interval of >12 months
|
16.8 months
Interval 4.6 to 23.2
|
SECONDARY outcome
Timeframe: Median follow-up was 25.7 months (range 3.0-47.2 months)OS = observed length of time from entry into the study to death or date of last contact
Outcome measures
| Measure |
Pemetrexed and Bevacizumab
n=34 Participants
Pemetrexed 500 mg/m2 IV on Day 1 of each 21 day cycle
Bevacizumab 15 mg/kg IV on Day 1 of each 21 day cycle
|
|---|---|
|
Distribution of Overall Survival (OS)
Platinum-free interval of <6 months
|
16.7 months
Interval 7.5 to 33.4
|
|
Distribution of Overall Survival (OS)
Platinum-free interval of 6-12 months
|
24.9 months
Interval 6.2 to 28.6
|
|
Distribution of Overall Survival (OS)
Platinum-free interval of >12 months
|
28.0 months
Interval 6.0 to
The upper bound of the 95% CI was not estimable for this group because of too few patients at risk.
|
SECONDARY outcome
Timeframe: 6 monthsDetailed serious adverse events and other adverse events are shown in the adverse event module of the results.
Outcome measures
| Measure |
Pemetrexed and Bevacizumab
n=34 Participants
Pemetrexed 500 mg/m2 IV on Day 1 of each 21 day cycle
Bevacizumab 15 mg/kg IV on Day 1 of each 21 day cycle
|
|---|---|
|
Toxicity Associated With Bevacizumab and Pemetrexed
Grade 3/4 hematologic toxicity
|
53 percentage of participants
|
|
Toxicity Associated With Bevacizumab and Pemetrexed
Most common non-hematologic toxicity - fatigue
|
94 percentage of participants
|
|
Toxicity Associated With Bevacizumab and Pemetrexed
Grade 3 renal toxicity
|
6 percentage of participants
|
|
Toxicity Associated With Bevacizumab and Pemetrexed
Gastrointestinal toxicity
|
91 percentage of participants
|
|
Toxicity Associated With Bevacizumab and Pemetrexed
Subsequently developed hematologic malignancies
|
6 percentage of participants
|
SECONDARY outcome
Timeframe: 6 monthsAs measured by RECIST criteria
Outcome measures
| Measure |
Pemetrexed and Bevacizumab
n=34 Participants
Pemetrexed 500 mg/m2 IV on Day 1 of each 21 day cycle
Bevacizumab 15 mg/kg IV on Day 1 of each 21 day cycle
|
|---|---|
|
Frequency of Clinical Response
Complete response
|
0 participants
|
|
Frequency of Clinical Response
Partial response
|
14 participants
|
|
Frequency of Clinical Response
Stable disease
|
18 participants
|
|
Frequency of Clinical Response
Progressive disease
|
2 participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: This outcome was not analyzed. Columbia University was to participate in this study but did not. They were to perform the correlative studies.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthsPopulation: This outcome was not analyzed. Columbia University was to participate in this study but did not. They were to perform the correlative studies.
Outcome measures
Outcome data not reported
POST_HOC outcome
Timeframe: 12 monthsOS = observed length of time from entry into the study to death or date of last contact
Outcome measures
| Measure |
Pemetrexed and Bevacizumab
n=34 Participants
Pemetrexed 500 mg/m2 IV on Day 1 of each 21 day cycle
Bevacizumab 15 mg/kg IV on Day 1 of each 21 day cycle
|
|---|---|
|
Overall Survival (OS)
|
79 percentage of participants
Interval 62.0 to 90.0
|
POST_HOC outcome
Timeframe: Median follow-up was 25.7 months (range 3.0-47.2 months)PFS = Period from study entry until disease progression, death, or date of last contact
Outcome measures
| Measure |
Pemetrexed and Bevacizumab
n=34 Participants
Pemetrexed 500 mg/m2 IV on Day 1 of each 21 day cycle
Bevacizumab 15 mg/kg IV on Day 1 of each 21 day cycle
|
|---|---|
|
Progression-free Survival (PFS)
|
7.9 months
Interval 4.6 to 10.9
|
POST_HOC outcome
Timeframe: Median follow-up was 25.7 months (range 3.0-47.2 months)OS = observed length of time from entry into the study to death or date of last contact
Outcome measures
| Measure |
Pemetrexed and Bevacizumab
n=34 Participants
Pemetrexed 500 mg/m2 IV on Day 1 of each 21 day cycle
Bevacizumab 15 mg/kg IV on Day 1 of each 21 day cycle
|
|---|---|
|
Overall Survival (OS)
|
25.7 months
Interval 15.4 to 29.8
|
POST_HOC outcome
Timeframe: 6 monthsOverall response rate = complete response + partial response Complete response = disappearance of all target and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response = at least a 30% decrease in the sum of the longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be non unequivocal progression of non-target lesions and no new lesions.
Outcome measures
| Measure |
Pemetrexed and Bevacizumab
n=34 Participants
Pemetrexed 500 mg/m2 IV on Day 1 of each 21 day cycle
Bevacizumab 15 mg/kg IV on Day 1 of each 21 day cycle
|
|---|---|
|
Overall Response Rate
|
41 percentage of participants
Interval 25.0 to 59.0
|
POST_HOC outcome
Timeframe: 6 monthsPopulation: 7 participants were not evauable by CA-125 criteria.
A CA-125 response was defined as at least a 50% reduction in CA-125 levels from a pretreatment sample following guidelines described by the Gynecological Cancer Intergroup.
Outcome measures
| Measure |
Pemetrexed and Bevacizumab
n=27 Participants
Pemetrexed 500 mg/m2 IV on Day 1 of each 21 day cycle
Bevacizumab 15 mg/kg IV on Day 1 of each 21 day cycle
|
|---|---|
|
CA-125 Response
75% CA-125 response
|
8 participants
|
|
CA-125 Response
50% CA-125 response
|
17 participants
|
|
CA-125 Response
No CA-125 response
|
2 participants
|
Adverse Events
Pemetrexed and Bevacizumab
Serious events: 5 serious events
Other events: 34 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pemetrexed and Bevacizumab
n=34 participants at risk
Pemetrexed 500 mg/m2 IV on Day 1 of each 21 day cycle
Bevacizumab 15 mg/kg IV on Day 1 of each 21 day cycle
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
2.9%
1/34
|
|
Gastrointestinal disorders
Vomiting
|
5.9%
2/34
|
|
Gastrointestinal disorders
Small bowel obstruction
|
2.9%
1/34
|
|
Vascular disorders
Thromobolic event
|
2.9%
1/34
|
|
Vascular disorders
Septic embolism
|
2.9%
1/34
|
Other adverse events
| Measure |
Pemetrexed and Bevacizumab
n=34 participants at risk
Pemetrexed 500 mg/m2 IV on Day 1 of each 21 day cycle
Bevacizumab 15 mg/kg IV on Day 1 of each 21 day cycle
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
82.4%
28/34
|
|
Investigations
Leukopenia
|
82.4%
28/34
|
|
Investigations
Thrombocytopenia
|
44.1%
15/34
|
|
Investigations
Neutropenia
|
97.1%
33/34
|
|
Immune system disorders
Allergy
|
32.4%
11/34
|
|
Cardiac disorders
Cardiovascular
|
32.4%
11/34
|
|
Blood and lymphatic system disorders
Impaired coagulation
|
17.6%
6/34
|
|
General disorders
Constitutional
|
94.1%
32/34
|
|
Skin and subcutaneous tissue disorders
Rash
|
67.6%
23/34
|
|
Endocrine disorders
Endocrine
|
2.9%
1/34
|
|
Gastrointestinal disorders
Gastrointestinal
|
79.4%
27/34
|
|
Renal and urinary disorders
Genitourinary
|
17.6%
6/34
|
|
General disorders
Hemorrhage
|
11.8%
4/34
|
|
Infections and infestations
Infection/febrile neutropenia
|
41.2%
14/34
|
|
Blood and lymphatic system disorders
Lymphatics
|
2.9%
1/34
|
|
Metabolism and nutrition disorders
Metabolic
|
91.2%
31/34
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal
|
5.9%
2/34
|
|
Nervous system disorders
Neurologic
|
61.8%
21/34
|
|
Eye disorders
Ocular
|
17.6%
6/34
|
|
General disorders
Pain
|
85.3%
29/34
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary
|
47.1%
16/34
|
|
Vascular disorders
Vascular
|
2.9%
1/34
|
|
Ear and labyrinth disorders
Auditory
|
2.9%
1/34
|
Additional Information
David G. Mutch, M.D.
Washington University School of Medicine
Phone: 314-362-2181
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place