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Bevacizumab and Intravenous or Intraperitoneal Chemotherapy in Treating Patients With Stage II-III Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer

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ClinicalTrials.gov Identifier: NCT00951496
Recruitment Status : Active, not recruiting
First Posted : August 4, 2009
Results First Posted : May 18, 2018
Last Update Posted : May 18, 2018
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Malignant Ovarian Mixed Epithelial Tumor
Ovarian Brenner Tumor
Ovarian Clear Cell Cystadenocarcinoma
Ovarian Endometrioid Adenocarcinoma
Ovarian Mucinous Cystadenocarcinoma
Ovarian Serous Cystadenocarcinoma
Stage IIA Fallopian Tube Cancer
Stage IIA Ovarian Cancer
Stage IIB Fallopian Tube Cancer
Stage IIB Ovarian Cancer
Stage IIC Fallopian Tube Cancer
Stage IIC Ovarian Cancer
Stage IIIA Fallopian Tube Cancer
Stage IIIA Ovarian Cancer
Stage IIIA Primary Peritoneal Cancer
Stage IIIB Fallopian Tube Cancer
Stage IIIB Ovarian Cancer
Stage IIIB Primary Peritoneal Cancer
Stage IIIC Fallopian Tube Cancer
Stage IIIC Ovarian Cancer
Stage IIIC Primary Peritoneal Cancer
Undifferentiated Ovarian Carcinoma
Interventions: Biological: Bevacizumab
Drug: Carboplatin
Drug: Cisplatin
Other: Laboratory Biomarker Analysis
Drug: Paclitaxel
Other: Quality-of-Life Assessment

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study was opened for accrual on July 27, 2009. Target accrual was about 1500 patients. The study was closed to enrollment on Nov 30, 2011 after enrolling 1560 individuals.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Eligibility was verified by a web-based procedure which reviewed all eligibility criteria prior to each subject’s registration. Prior to treatment randomization patients were stratified by stage of disease and size of residual disease.

Reporting Groups
  Description
Arm I (Paclitaxel, Carboplatin, Bevcizumab IV) Six cycles of Paclitaxel 80mg/m2 IV over ` hours days 1, 8 and 15. Carboplatin AUC 6 IV on day 1, Bevacizumab 15mg/kg IV on day 1 beginning on cycle 2, followed by bevacizumab 15mg/kg for cycles 7-22.
Arm II (Paclitaxel,carboplatinIP, Bevacizumab IP) Six cycles of Paclitaxel 80mg/m2 IV over 1 hour days 1, 8, and 15, Carboplatin AUC 6 IP on day1, Bevacizumab 15mg/kg IV on day 1 beginning on cycle 2 followed by bevacizumab 15mg/KG for cycles 7-22
Arm III (Paclitaxel IP, Cisplatin, Bevacizumab) Six cycles of Paclitaxel 135 mg/m2 IV over 3 hours day 1, Cisplatin 75 mg/m2 IP on day 2, Paclitaxel 60 mg/m2 IP on day 8, Bevacizumab 15 mg/kg IV on day 1 beginning with cycle 2, followed by bevacizumab 15 mg/kg for cycles 7-22.

Participant Flow:   Overall Study
    Arm I (Paclitaxel, Carboplatin, Bevcizumab IV)   Arm II (Paclitaxel,carboplatinIP, Bevacizumab IP)   Arm III (Paclitaxel IP, Cisplatin, Bevacizumab)
STARTED   521   518   521 
COMPLETED   511   510   508 
NOT COMPLETED   10   8   13 
Did not initiate study treatment                10                8                13 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Arm I (Paclitaxel, Carboplatin, Bevcizumab IV) Six cycles of Paclitaxel 80mg/m2 IV over ` hours days 1, 8 and 15. Carboplatin AUC 6 IV on day 1, Bevacizumab 15mg/kg IV on day 1 beginning on cycle 2, followed by bevacizumab 15mg/kg for cycles 7-22.
Arm II (Paclitaxel,carboplatinIP, Bevacizumab IP) Six cycles of Paclitaxel 80mg/m2 IV over 1 hour days 1, 8, and 15, Carboplatin AUC 6 IP on day1, Bevacizumab 15mg/kg IV on day 1 beginning on cycle 2 followed by bevacizumab 15mg/KG for cycles 7-22
Arm III (Paclitaxel IP, Cisplatin, Bevacizumab) Six cycles of Paclitaxel 135 mg/m2 IV over 3 hours day 1, Cisplatin 75 mg/m2 IP on day 2, Paclitaxel 60 mg/m2 IP on day 8, Bevacizumab 15 mg/kg IV on day 1 beginning with cycle 2, followed by bevacizumab 15 mg/kg for cycles 7-22.
Total Total of all reporting groups

Baseline Measures
   Arm I (Paclitaxel, Carboplatin, Bevcizumab IV)   Arm II (Paclitaxel,carboplatinIP, Bevacizumab IP)   Arm III (Paclitaxel IP, Cisplatin, Bevacizumab)   Total 
Overall Participants Analyzed 
[Units: Participants]
 521   518   521   1560 
Age, Customized 
[Units: Participants]
Count of Participants
       
<40 years   27   13   18   58 
40 - 49 years   101   77   95   273 
50 - 59 years   187   178   199   564 
60 -69 years   152   181   151   484 
70 - 79 years   51   64   53   168 
>79 years   3   5   5   13 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      521 100.0%      518 100.0%      521 100.0%      1560 100.0% 
Male      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
       
American Indian or Alaska Native      2   0.4%      2   0.4%      2   0.4%      6   0.4% 
Asian      15   2.9%      15   2.9%      17   3.3%      47   3.0% 
Native Hawaiian or Other Pacific Islander      1   0.2%      1   0.2%      0   0.0%      2   0.1% 
Black or African American      17   3.3%      17   3.3%      17   3.3%      51   3.3% 
White      473  90.8%      478  92.3%      476  91.4%      1427  91.5% 
More than one race      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      13   2.5%      5   1.0%      9   1.7%      27   1.7% 
FIGO Stage FIGO (International Federation of Gynecology & Obstetrics) Staging [1] 
[Units: Participants]
Count of Participants
       
Stage I-II   56   56   51   163 
Stage III   441   432   432   1305 
Stage IV   24   30   38   92 
[1] FIGO staging of the Ovary was used. FIGO stage I includes all participants with disease confined to ovary. This stage has the best outcome, between 75 to 90% survival at 5 years. Stage II includes all participants with disease in ovaries and spread limited to pelvis (45 to 60% survival at 5 years). Stage III includes all participants with disease limited to abdomen. Stage IV disease includes all participants with distant metastasis outside the abdominal cavity. This stage has the worst outcome (<20% survival at 5 years)
Residual Disease Diameter 
[Units: Participants]
Count of Participants
       
Microscopic only   297   297   305   899 
0 < diameter <= 1cm   182   189   182   553 
> 1cm   42   32   34   108 
Histology/Grade of tumor [1] 
[Units: Participants]
Count of Participants
       
Serous/Grade1   20   12   27   59 
Serous/Grade 2   43   36   35   114 
Serous/Grade 3   370   379   377   1126 
Endometrioid   5   2   4   11 
Clear Cell   32   29   26   87 
Mucinous   2   5   5   12 
Other/Not specified   48   55   47   150 
[1] The Histology/Grade lists how many participants entered the study with each type of tumor histology and the grade for the serous tumors. Histology is the type of tissue that the tumor is comprised of. The histologic types listed below include serous, endometrioid, clear cell, mucinous and other or not specified. Grading refers to (along with staging) describes the severity. Grade 1 tumor cells look a lot like normal ovarian cells. The outcome is good for grade I tumors. Grade 2 tumors are well differentiated. Grade 3 cells are more irregular and likely to metastasize.


  Outcome Measures

1.  Primary:   Median Progression-free Survival   [ Time Frame: Progression-free survival is measured from date of randomization until first indication of progression based on RECIST criteria or death from any cause, or if progression-free at last contact, the date of last disease assessment up to 10 years. ]

2.  Secondary:   Patients With Adverse Events by Treatment Group, as Defined by NCI CTCAE (Common Terminology Criteria for Adverse Events Version 3.0) Version 3.0   [ Time Frame: During treatment and up to 30 days after end of treatment ]

3.  Secondary:   Overall Survival   [ Time Frame: Up to 10 years ]

4.  Secondary:   Patient Reported Quality of Life (QOL)   [ Time Frame: Time points: Baseline, prior to cycle 4, prior to cycle 7, prior to cycle 13, prior to cycle 21, up to 84 weeks post starting treatment ]

5.  Secondary:   Patient Reported Neurotoxicity (Ntx)   [ Time Frame: Time points: Baseline, prior to cycle 4, prior to cycle 7, prior to cycle 13, prior to cycle 21, 84 weeks post starting treatment ]

6.  Secondary:   Patient Reported Fatigue   [ Time Frame: Time points: Baseline, prior to cycle 4, prior to cycle 7, prior to cycle 13, prior to cycle 21, 84 weeks post starting treatment ]

7.  Secondary:   Patient Reported Nausea   [ Time Frame: Time points: Baseline, prior to cycle 4, prior to cycle 7, prior to cycle 13, prior to cycle 21, 84 weeks post starting treatment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Linda Gedeon for Mark Brady, PhD
Organization: NRG Oncology
phone: 716-845-1169
e-mail: lgedeon@gogstats.org



Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00951496     History of Changes
Other Study ID Numbers: NCI-2011-01956
NCI-2011-01956 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000650601
GOG-0252 ( Other Identifier: NRG Oncology )
GOG-0252 ( Other Identifier: CTEP )
U10CA180868 ( U.S. NIH Grant/Contract )
U10CA027469 ( U.S. NIH Grant/Contract )
First Submitted: August 1, 2009
First Posted: August 4, 2009
Results First Submitted: October 4, 2017
Results First Posted: May 18, 2018
Last Update Posted: May 18, 2018