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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00262847
First received: December 6, 2005
Last updated: June 18, 2014
Last verified: June 2014
Results First Received: July 9, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Brenner Tumor
Fallopian Tube Cancer
Ovarian Clear Cell Cystadenocarcinoma
Ovarian Endometrioid Adenocarcinoma
Ovarian Mixed Epithelial Carcinoma
Ovarian Mucinous Cystadenocarcinoma
Ovarian Serous Cystadenocarcinoma
Ovarian Undifferentiated Adenocarcinoma
Primary Peritoneal Cavity Cancer
Stage III Ovarian Epithelial Cancer
Stage IV Ovarian Epithelial Cancer
Interventions: Other: hydrocortisone/placebo
Drug: paclitaxel
Drug: carboplatin
Biological: bevacizumab

  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  
Number of Participants  
[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  
International Federation of Gynecologic and Obstetrics (FIGO) Stage [2]
[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  
Histologic Type [3]
[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  
Tumor Grade [4]
[units: participants]
       
3     445     465     460     1370  
2     102     86     97     285  
1     36     28     18     82  
Not graded     42     46     48     136  
[1] 5-point, ordinal scale specifying patient's ability to perform activities from 0(fully active) to 4(completely disabled, no self-care).
[2] Clinical staging for primary carcinoma of the ovary (1985) from Stage 1 (limited to ovaries) to Stage 4 (distant metastatis)
[3] Histologic(cell) type was obtained from the central GOG Pathology Committee review updated in September 2010.
[4] 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 posted.   Anticipated Posting 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


No publications provided by National Cancer Institute (NCI)

Publications automatically indexed to this study:

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00262847     History of Changes
Other Study ID Numbers: NCI-2009-00590, NCI-2009-00590, CDR0000455114, GOG-0218, GOG-0218, U10CA027469
Study First Received: December 6, 2005
Results First Received: July 9, 2013
Last Updated: June 18, 2014
Health Authority: United States: Food and Drug Administration