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Trial record 2 of 526 for:    "Primary Peritoneal Carcinoma"

Trial of Pemetrexed and Bevacizumab for Recurrent Ovarian Primary Peritoneal Carcinoma

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ClinicalTrials.gov Identifier: NCT00868192
Recruitment Status : Completed
First Posted : March 24, 2009
Results First Posted : October 20, 2014
Last Update Posted : October 20, 2014
Sponsor:
Collaborator:
Columbia University
Information provided by (Responsible Party):
Washington University School of Medicine

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Ovarian Carcinoma
Primary Peritoneal Carcinoma
Interventions Drug: Pemetrexed
Drug: Bevacizumab
Enrollment 38
Recruitment Details The study was open to participant enrollment on 05/28/2008 and closed to participant enrollment on 11/30/2010.
Pre-assignment Details  
Arm/Group Title Pemetrexed and Bevacizumab
Hide Arm/Group Description

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

Period Title: Overall Study
Started 38
Completed 34
Not Completed 4
Reason Not Completed
Ineligible             4
Arm/Group Title Pemetrexed and Bevacizumab
Hide Arm/Group Description

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 Number of Baseline Participants 34
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 34 participants
61.5
(31 to 86)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants
Female
34
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 34 participants
34
Stage   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 34 participants
Stage I/II 1
Stage III 27
Stage IV 6
[1]
Measure Description:

Staging

  • I:The cancer is only within the ovary(ies) or fallopian tube(s)
  • II:Cancer involves 1 or both ovaries or fallopian tube(s) with pelvic extension
  • III: Cancer involves 1 or both ovaries or fallopian tubes(s) with microscopically confirmed peritoneal metastases outside the pelvis and/or regional lymph node metastasis (also can be primary peritoneal cancer)
  • IV:Distant spreading (also can be primary peritoneal cancer)
Histology  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 34 participants
Serous 24
Endometriod 2
Mixed 3
Other 5
Tumor grade   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 34 participants
Grade 1 3
Grade 2 1
Grade 3 30
[1]
Measure Description:

G1: The tissue is well-differentiated (contains many healthy-looking cells).

G2: The tissue is moderately differentiated (more cells appear abnormal than healthy).

G3:The tissue is poorly differentiated or undifferentiated (all or most cells appear abnormal).

Pathologic diagnosis  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 34 participants
Ovarian 27
Fallopian tube 1
Primary peritoneal 6
Gynecologic Oncology Group (GOG) Performance Status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 34 participants
0 22
1 12
[1]
Measure Description:

GOG Performance Status

  • 0 = Fully active, unrestricted activities of daily living
  • 1 = Ambulatory, but restricted in strenuous activity
Prior number of chemotherapy regimens  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 34 participants
1 20
2 14
Platinum-free interval  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 34 participants
<6 months 12
6-12 months 11
>12 months 11
1.Primary Outcome
Title Progression-free Survival (PFS)
Hide Description PFS = Period from study entry until disease progression, death, or date of last contact
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pemetrexed and Bevacizumab
Hide Arm/Group Description:

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 Number of Participants Analyzed 34
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
56
(38 to 71)
2.Secondary Outcome
Title Distribution of Progression-free Survival (PFS)
Hide Description PFS = Period from study entry until disease progression, death, or date of last contact
Time Frame Median follow-up was 25.7 months (range 3.0-47.2 months)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pemetrexed and Bevacizumab
Hide Arm/Group Description:

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 Number of Participants Analyzed 34
Median (95% Confidence Interval)
Unit of Measure: months
Platinum-free interval of <6 months
6.7
(4.1 to 9.9)
Platinum-free interval of 6-12 months
4.7
(2.8 to 8.4)
Platinum-free interval of >12 months
16.8
(4.6 to 23.2)
3.Secondary Outcome
Title Distribution of Overall Survival (OS)
Hide Description OS = observed length of time from entry into the study to death or date of last contact
Time Frame Median follow-up was 25.7 months (range 3.0-47.2 months)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pemetrexed and Bevacizumab
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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 Number of Participants Analyzed 34
Median (95% Confidence Interval)
Unit of Measure: months
Platinum-free interval of <6 months
16.7
(7.5 to 33.4)
Platinum-free interval of 6-12 months
24.9
(6.2 to 28.6)
Platinum-free interval of >12 months
28.0 [1] 
(6.0 to NA)
[1]
The upper bound of the 95% CI was not estimable for this group because of too few patients at risk.
4.Secondary Outcome
Title Toxicity Associated With Bevacizumab and Pemetrexed
Hide Description Detailed serious adverse events and other adverse events are shown in the adverse event module of the results.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pemetrexed and Bevacizumab
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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 Number of Participants Analyzed 34
Measure Type: Number
Unit of Measure: percentage of participants
Grade 3/4 hematologic toxicity 53
Most common non-hematologic toxicity - fatigue 94
Grade 3 renal toxicity 6
Gastrointestinal toxicity 91
Subsequently developed hematologic malignancies 6
5.Secondary Outcome
Title Frequency of Clinical Response
Hide Description As measured by RECIST criteria
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pemetrexed and Bevacizumab
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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 Number of Participants Analyzed 34
Measure Type: Number
Unit of Measure: participants
Complete response 0
Partial response 14
Stable disease 18
Progressive disease 2
6.Secondary Outcome
Title Gene Expression as Assessed by Illumina cDNA Mediated Annealing, Selection, Extension and Ligation (DASL) Microarray From Paraffin-embedded Tumor Specimens With Response to Pemetrexed and Bevacizumab
Hide Description [Not Specified]
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome was not analyzed. Columbia University was to participate in this study but did not. They were to perform the correlative studies.
Arm/Group Title Pemetrexed and Bevacizumab
Hide Arm/Group Description:

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 Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Association Between Levels of Thymidylate Synthase, Dihydrofolate Reductase, and Glycinamide Ribonucleotide Formyl Transferase and Ovarian Response to Pemetrexed and Bevacizumab
Hide Description [Not Specified]
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome was not analyzed. Columbia University was to participate in this study but did not. They were to perform the correlative studies.
Arm/Group Title Pemetrexed and Bevacizumab
Hide Arm/Group Description:

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 Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
8.Post-Hoc Outcome
Title Overall Survival (OS)
Hide Description OS = observed length of time from entry into the study to death or date of last contact
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pemetrexed and Bevacizumab
Hide Arm/Group Description:

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 Number of Participants Analyzed 34
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
79
(62 to 90)
9.Post-Hoc Outcome
Title Progression-free Survival (PFS)
Hide Description PFS = Period from study entry until disease progression, death, or date of last contact
Time Frame Median follow-up was 25.7 months (range 3.0-47.2 months)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pemetrexed and Bevacizumab
Hide Arm/Group Description:

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 Number of Participants Analyzed 34
Median (95% Confidence Interval)
Unit of Measure: months
7.9
(4.6 to 10.9)
10.Post-Hoc Outcome
Title Overall Survival (OS)
Hide Description OS = observed length of time from entry into the study to death or date of last contact
Time Frame Median follow-up was 25.7 months (range 3.0-47.2 months)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pemetrexed and Bevacizumab
Hide Arm/Group Description:

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 Number of Participants Analyzed 34
Median (95% Confidence Interval)
Unit of Measure: months
25.7
(15.4 to 29.8)
11.Post-Hoc Outcome
Title Overall Response Rate
Hide Description

Overall 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.

Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pemetrexed and Bevacizumab
Hide Arm/Group Description:

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 Number of Participants Analyzed 34
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
41
(25 to 59)
12.Post-Hoc Outcome
Title CA-125 Response
Hide Description 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.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
7 participants were not evauable by CA-125 criteria.
Arm/Group Title Pemetrexed and Bevacizumab
Hide Arm/Group Description:

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 Number of Participants Analyzed 27
Measure Type: Number
Unit of Measure: participants
50% CA-125 response 17
75% CA-125 response 8
No CA-125 response 2
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pemetrexed and Bevacizumab
Hide Arm/Group Description

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

All-Cause Mortality
Pemetrexed and Bevacizumab
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Pemetrexed and Bevacizumab
Affected / at Risk (%)
Total   5/34 (14.71%) 
Gastrointestinal disorders   
Nausea  1  1/34 (2.94%) 
Vomiting  1  2/34 (5.88%) 
Small bowel obstruction  1  1/34 (2.94%) 
Vascular disorders   
Thromobolic event  1  1/34 (2.94%) 
Septic embolism  1  1/34 (2.94%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Pemetrexed and Bevacizumab
Affected / at Risk (%)
Total   34/34 (100.00%) 
Blood and lymphatic system disorders   
Anemia  1  28/34 (82.35%) 
Impaired coagulation  1  6/34 (17.65%) 
Lymphatics  1  1/34 (2.94%) 
Cardiac disorders   
Cardiovascular  1  11/34 (32.35%) 
Ear and labyrinth disorders   
Auditory  1  1/34 (2.94%) 
Endocrine disorders   
Endocrine  1  1/34 (2.94%) 
Eye disorders   
Ocular  1  6/34 (17.65%) 
Gastrointestinal disorders   
Gastrointestinal  1  27/34 (79.41%) 
General disorders   
Constitutional  1  32/34 (94.12%) 
Hemorrhage  1  4/34 (11.76%) 
Pain  1  29/34 (85.29%) 
Immune system disorders   
Allergy  1  11/34 (32.35%) 
Infections and infestations   
Infection/febrile neutropenia  1  14/34 (41.18%) 
Investigations   
Leukopenia  1  28/34 (82.35%) 
Thrombocytopenia  1  15/34 (44.12%) 
Neutropenia  1  33/34 (97.06%) 
Metabolism and nutrition disorders   
Metabolic  1  31/34 (91.18%) 
Musculoskeletal and connective tissue disorders   
Musculoskeletal  1  2/34 (5.88%) 
Nervous system disorders   
Neurologic  1  21/34 (61.76%) 
Renal and urinary disorders   
Genitourinary  1  6/34 (17.65%) 
Respiratory, thoracic and mediastinal disorders   
Pulmonary  1  16/34 (47.06%) 
Skin and subcutaneous tissue disorders   
Rash  1  23/34 (67.65%) 
Vascular disorders   
Vascular  1  1/34 (2.94%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: David G. Mutch, M.D.
Organization: Washington University School of Medicine
Phone: 314-362-2181
Publications:
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00868192     History of Changes
Other Study ID Numbers: 08-0508 / 201102272
First Submitted: March 18, 2009
First Posted: March 24, 2009
Results First Submitted: October 2, 2014
Results First Posted: October 20, 2014
Last Update Posted: October 20, 2014