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A Study of Carboplatin and Gemcitabine Plus Bevacizumab in Patients With Ovary, Peritoneal, or Fallopian Tube Carcinoma (OCEANS)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT00434642
First received: February 9, 2007
Last updated: September 26, 2011
Last verified: September 2011
History of Changes
Results First Received: September 26, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Ovarian Cancer
Interventions: Drug: Carboplatin
Drug: Gemcitabine
Drug: Bevacizumab
Drug: Placebo

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Carboplatin and Gemcitabine + Bevacizumab Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Bevacizumab 15 mg/kg was administered IV on Day 1 of each of the six 21-day treatment cycles. The bevacizumab dose was based on the patient’s weight at baseline and remained the same throughout the study.
Carboplatin and Gemcitabine + Placebo Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Placebo was administered by IV on Day 1 of each of the six 21-day treatment cycles.

Participant Flow:   Overall Study
    Carboplatin and Gemcitabine + Bevacizumab     Carboplatin and Gemcitabine + Placebo  
STARTED     242     242  
COMPLETED     173     153  
NOT COMPLETED     69     89  
Death                 63                 78  
Lost to Follow-up                 0                 2  
Withdrawal by Subject                 6                 9  



  Baseline Characteristics
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Reporting Groups
  Description
Carboplatin and Gemcitabine + Bevacizumab Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Bevacizumab 15 mg/kg was administered IV on Day 1 of each of the six 21-day treatment cycles. The bevacizumab dose was based on the patient’s weight at baseline and remained the same throughout the study.
Carboplatin and Gemcitabine + Placebo Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Placebo was administered by IV on Day 1 of each of the six 21-day treatment cycles.
Total Total of all reporting groups

Baseline Measures
    Carboplatin and Gemcitabine + Bevacizumab     Carboplatin and Gemcitabine + Placebo     Total  
Number of Participants  
[units: participants]
 		  242     242     484  
Age  
[units: years]
Mean ± Standard Deviation 		  60.5  ± 9.8     61.6  ± 10.2     61.0  ± 10.0  
Gender  
[units: participants]
 		     
Female     242     242     484  
Male     0     0     0  



  Outcome Measures
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1.  Primary:   Progression Free Survival (PFS) as Determined by the Investigator, Per Response Evaluation Criteria for Solid Tumors (RECIST)   [ Time Frame: From randomization through September 17, 2010 ]
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Measure Type Primary
Measure Title Progression Free Survival (PFS) as Determined by the Investigator, Per Response Evaluation Criteria for Solid Tumors (RECIST)
Measure Description PFS was defined as the time from randomization to disease progression (PD), as determined by the investigator, or death due to any cause. PD: At least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started; the appearance of 1 or more new lesions; and/or the unequivocal progression of existing non-target lesions. Lesions were assessed by computed tomography (CT), magnetic resonance imaging (MRI), or ultrasound every 9 weeks.
Time Frame From randomization through September 17, 2010  
Safety Issue No  

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.
Intent-to-treat population: All patients randomized to treatment (242 patients in each treatment group).

Reporting Groups
  Description
Carboplatin and Gemcitabine + Bevacizumab Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Bevacizumab 15 mg/kg was administered IV on Day 1 of each of the six 21-day treatment cycles. The bevacizumab dose was based on the patient's weight at baseline and remained the same throughout the study.
Carboplatin and Gemcitabine + Placebo Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Placebo was administered by IV on Day 1 of each of the six 21-day treatment cycles.

Measured Values
    Carboplatin and Gemcitabine + Bevacizumab     Carboplatin and Gemcitabine + Placebo  
Number of Participants Analyzed  
[units: participants]
 		  242     242  
Progression Free Survival (PFS) as Determined by the Investigator, Per Response Evaluation Criteria for Solid Tumors (RECIST)  
[units: Months]
Median ( 95% Confidence Interval ) 		  12.4  
  ( 11.40 to 12.71 )   		  8.4  
  ( 8.31 to 9.66 )  


Statistical Analysis 1 for Progression Free Survival (PFS) as Determined by the Investigator, Per Response Evaluation Criteria for Solid Tumors (RECIST)
Groups [1] All groups
Method [2] Log Rank
P Value [3] <0.0001
Hazard Ratio (HR) [4] 0.484
95% Confidence Interval ( 0.388 to 0.605 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  The null hypothesis was that there was no difference between the 2 treatment groups, ie, that the hazard ratio is equal to 1. The alternative hypothesis was that progression free survival was longer in the carboplatin and gemcitabine + bevacizumab group, ie, that the hazard ratio is not equal to 1.
[2] Other relevant information, such as adjustments or degrees of freedom:
  The analysis was stratified for time since the last platinum therapy (6–12, >12 months) and cytoreductive surgery for recurrent disease (yes, no).
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  A P-value < 0.05 was required for significance.
[4] Other relevant estimation information:
  The hazard ratio was estimated using Cox regression. The hazard ratio is relative to the carboplatin and gemcitabine + placebo group.



2.  Secondary:   Percentage of Patients With an Objective Response as Determined by the Investigator, Per Response Evaluation Criteria for Solid Tumors (RECIST)   [ Time Frame: From randomization through September 17, 2010 ]
  Show Outcome Measure 2

3.  Secondary:   Duration of Objective Response (OR) as Determined by the Investigator, Per Response Evaluation Criteria for Solid Tumors (RECIST)   [ Time Frame: From randomization through September 17, 2010 ]
  Show Outcome Measure 3

4.  Secondary:   Overall Survival   [ Time Frame: From randomization through September 17, 2010 ]
  Show Outcome Measure 4

5.  Secondary:   Percentage of Patients Who Had a Gastrointestinal Perforation (GIP)   [ Time Frame: From first treatment through September 17, 2010 ]
  Show Outcome Measure 5

6.  Secondary:   Percentage of Patients Who Had at Least 1 Adverse Event   [ Time Frame: From first treatment through September 17, 2010 ]
  Show Outcome Measure 6


  Serious Adverse Events
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  Other Adverse Events
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  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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
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.


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.  


Results Point of Contact:  
Name/Title: Medical Communications
Organization: Hoffman-LaRoche
phone: 800-821-8590


No publications provided by Genentech

Publications automatically indexed to this study:


Responsible Party: Genentech
ClinicalTrials.gov Identifier: NCT00434642     History of Changes
Other Study ID Numbers: AVF4095g
Study First Received: February 9, 2007
Results First Received: September 26, 2011
Last Updated: September 26, 2011
Health Authority: United States: Food and Drug Administration