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Carboplatin and Paclitaxel With or Without Bevacizumab in Treating Patients With Stage III or Stage IV Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00262847
First received: December 6, 2005
Last updated: August 18, 2015
Last verified: February 2015
Results First Received: July 9, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Fallopian Tube Clear Cell Adenocarcinoma
Fallopian Tube Endometrioid Adenocarcinoma
Fallopian Tube Mucinous Adenocarcinoma
Fallopian Tube Serous Adenocarcinoma
Fallopian Tube Transitional Cell Carcinoma
Malignant Ovarian Mixed Epithelial Tumor
Ovarian Brenner Tumor
Ovarian Clear Cell Adenocarcinoma
Ovarian Endometrioid Adenocarcinoma
Ovarian Mucinous Adenocarcinoma
Ovarian Serous Adenocarcinoma
Ovarian Transitional Cell Carcinoma
Primary Peritoneal Serous Adenocarcinoma
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
Stage IV Fallopian Tube Cancer
Stage IV Ovarian Cancer
Stage IV Primary Peritoneal Cancer
Undifferentiated Fallopian Tube Carcinoma
Undifferentiated Ovarian Carcinoma
Interventions: Biological: Bevacizumab
Drug: Carboplatin
Other: Laboratory Biomarker Analysis
Drug: Paclitaxel
Other: Placebo
Other: Quality-of-Life Assessment

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Between October 2005 and June 2009, 1873 women were enrolled from 336 institutions in the United States, Canada, South Korea, and Japan.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Arm I (Placebo, Paclitaxel, Carboplatin)

Control therapy:

Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus placebo (starting in cycle 2) every 3 weeks.

Cycles 7-22 received placebo every 3 weeks.

Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab)

Bevacizumab-initiation therapy:

Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus bevacizumab, 15 mg/kg (starting in cycle 2) every 3 weeks.

Cycles 7-22 received placebo every 3 weeks.

Arm III (Paclitaxel, Carboplatin, Bevacizumab)

Bevacizumab-throughout therapy:

Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus bevacizumab, 15 mg/kg (starting in cycle 2) every 3 weeks.

Cycles 7-22 received bevacizumab, 15 mg/kg every 3 weeks.


Participant Flow:   Overall Study
    Arm I (Placebo, Paclitaxel, Carboplatin)   Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab)   Arm III (Paclitaxel, Carboplatin, Bevacizumab)
STARTED   625 [1]   625 [1]   623 [1] 
COMPLETED   107   112   227 
NOT COMPLETED   518   513   396 
Disease Progression                309                274                195 
Patient Refusal                41                52                47 
Adverse Event                74                88                108 
Death                8                8                11 
Concomitant disease                3                2                4 
Other Reasons                79                88                27 
Did not receive study treatment                4                1                4 
[1] Total enrolled and included in efficacy analysis



  Baseline Characteristics
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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 (Placebo, Paclitaxel, Carboplatin)

Control therapy:

Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus placebo (starting in cycle 2) every 3 weeks.

Cycles 7-22 received placebo every 3 weeks.

Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab)

Bevacizumab-initiation therapy:

Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus bevacizumab, 15 mg/kg (starting in cycle 2) every 3 weeks.

Cycles 7-22 received placebo every 3 weeks.

Arm III (Paclitaxel, Carboplatin, Bevacizumab)

Bevacizumab-throughout therapy:

Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus bevacizumab, 15 mg/kg (starting in cycle 2) every 3 weeks.

Cycles 7-22 received bevacizumab, 15 mg/kg every 3 weeks.

Total Total of all reporting groups

Baseline Measures
   Arm I (Placebo, Paclitaxel, Carboplatin)   Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab)   Arm III (Paclitaxel, Carboplatin, Bevacizumab)   Total 
Overall Participants Analyzed 
[Units: Participants]
 625   625   623   1873 
Age 
[Units: Years]
Mean (Standard Deviation)
 59.3  (10.9)   60.1  (10.3)   59.7  (10.6)   59.7  (10.6) 
Gender 
[Units: Participants]
       
Female   625   625   623   1873 
Male   0   0   0   0 
Race/Ethnicity, Customized 
[Units: Participant]
       
Non-Hispanic white   526   519   521   1566 
Asian   41   37   39   117 
Non-Hispanic black   25   28   27   80 
Hispanic   21   28   25   74 
Other or unspecified   12   13   11   36 
Region of Enrollment 
[Units: Participants]
       
United States   596   596   599   1791 
Canada   1   5   3   9 
Japan   21   12   12   45 
Korea, Republic of   7   12   9   28 
Gynecologic Oncology Group (GOG) Performance Status [1] 
[Units: Participants]
       
0 - fully active   311   315   305   931 
1 - restricted strenuous activity, ambulatory   272   270   267   809 
2 - ambulatory, difficulty walking   42   40   51   133 
3 - limited self-care, partly confined to bed   0   0   0   0 
4 - completely disabled, no self-care   0   0   0   0 
[1] 5-point, ordinal scale specifying patient's ability to perform activities from 0(fully active) to 4(completely disabled, no self-care).
International Federation of Gynecologic and Obstetrics (FIGO) Stage [1] 
[Units: Participants]
       
1-limited to ovaries   0   0   0   0 
1A-1 ovary involved, no ascites   0   0   0   0 
1B-both ovaries involved, no ascites   0   0   0   0 
1C-disease with capsules ruptured or ascites   0   0   0   0 
2-disease with pelvic extension   0   0   0   0 
2A-disease with extension to uterus and or tubes   0   0   0   0 
2B-disease with extension to other pelvic tissues   0   0   0   0 
2C-disease with capsules ruptured or ascites   0   0   0   0 
3-disease w/ macroscopic implants outside pelvis   218   205   216   639 
3-disease w/ implants > 1 cm outside pelvis   254   256   242   752 
3A-disease w/ microscopic implants, negative nodes   0   0   0   0 
3B-disease w/ abdominal implants <2cm, neg nodes   0   0   0   0 
3C-disease w/ abdominal implants >2cm, pos nodes   0   0   0   0 
4-distant metastatis   153   164   165   482 
[1] Clinical staging for primary carcinoma of the ovary (1985) from Stage 1 (limited to ovaries) to Stage 4 (distant metastatis)
Histologic Type [1] 
[Units: Participants]
       
Serous adenocarcinoma   541   519   524   1584 
Endometrioid   21   14   24   59 
Clear cell   12   23   20   55 
Mucinous   6   5   8   19 
Other or not specified   45   64   47   156 
[1] Histologic(cell) type was obtained from the central GOG Pathology Committee review updated in September 2010.
Tumor Grade [1] 
[Units: Participants]
       
 445   465   460   1370 
 102   86   97   285 
 36   28   18   82 
Not graded   42   46   48   136 
[1] Tumor grade was obtained from the central GOG Pathology Committee review updated in September 2010. All clear-cell tumors were classified as grade 3.


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Progression-free Survival   [ Time Frame: From study entry until first disease progression, death or date of last contact, up to 6 years ]

2.  Secondary:   Overall Survival   [ Time Frame: From study entry to death or last contact, up to 6 years ]

3.  Secondary:   Impact on Quality of Life Measured by the Functional Assessment of Cancer Therapy-Ovary Trial Outcome Index (FACT-O TOI)   [ Time Frame: At baseline, 9, 18, 36, 60, and 84 weeks ]

4.  Secondary:   Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0   [ Time Frame: Up to 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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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: Melissa Leventhal
Organization: Gynecologic Oncology Group (GOG) Statistical and Data Center
phone: 716-845-4030
e-mail: mleventhal@gogstats.org


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00262847     History of Changes
Other Study ID Numbers: NCI-2009-00590
NCI-2009-00590 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000455114
GOG-0218 ( Other Identifier: NRG Oncology )
GOG-0218 ( Other Identifier: CTEP )
U10CA180868 ( US NIH Grant/Contract Award Number )
U10CA027469 ( US NIH Grant/Contract Award Number )
Study First Received: December 6, 2005
Results First Received: July 9, 2013
Last Updated: August 18, 2015
Health Authority: United States: Food and Drug Administration