A Study to Evaluate rhuMab 2C4 and Gemcitabine in Subjects With Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT00096993
First received: November 17, 2004
Last updated: June 8, 2015
Last verified: June 2015
Results First Received: May 26, 2015  
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: Ovarian Cancer
Peritoneal Cancer
Fallopian Tube Cancer
Interventions: Drug: Placebo
Drug: Gemcitabine
Drug: Pertuzumab

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
One subject in the placebo + gemcitabine arm did not receive any study treatment as the subject died of a cerebrovascular accident prior to the first scheduled dose. This subject was excluded from both the efficacy and safety analyses, per protocol.

Reporting Groups
  Description
Placebo + Gemcitabine

Participants received placebo intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). In addition, participants received gemcitabine 800 mg/m^2 intravenously on Days 1 and 8 of every 3 week cycle for up to 1 year (up to 17 treatment cycles).

Placebo: Placebo was provided as a single-use formulation for infusion.

Gemcitabine: Gemcitabine was provided as a solution for infusion.

Pertuzumab + Gemcitabine

Participants received pertuzumab intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). Participants received pertuzumab at a loading dose of 840 mg in Cycle 1 followed by a dose of 420 mg in Cycles 2 and beyond. In addition, participants received gemcitabine 800 mg/m^2 intravenously on Days 1 and 8 of every 3 week cycle for up to 1 year (up to 17 treatment cycles

Gemcitabine: Gemcitabine was provided as a solution for infusion.

Pertuzumab: Pertuzumab was provided as a single-use formulation for infusion.


Participant Flow:   Overall Study
    Placebo + Gemcitabine     Pertuzumab + Gemcitabine  
STARTED     66     65  
COMPLETED     1     0  
NOT COMPLETED     65     65  
Death                 1                 0  
Disease progression                 56                 53  
Adverse Event                 2                 8  
Subject's decision                 3                 1  
Physician Decision                 2                 1  
Non-compliance                 0                 1  
Other unspecified                 1                 1  



  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.
Safety population: All participants who received any amount of study treatment.

Reporting Groups
  Description
Placebo + Gemcitabine

Participants received placebo intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). In addition, participants received gemcitabine 800 mg/m^2 intravenously on Days 1 and 8 of every 3 week cycle for up to 1 year (up to 17 treatment cycles).

Placebo: Placebo was provided as a single-use formulation for infusion.

Gemcitabine: Gemcitabine was provided as a solution for infusion.

Pertuzumab + Gemcitabine

Participants received pertuzumab intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). Participants received pertuzumab at a loading dose of 840 mg in Cycle 1 followed by a dose of 420 mg in Cycles 2 and beyond. In addition, participants received gemcitabine 800 mg/m^2 intravenously on Days 1 and 8 of every 3 week cycle for up to 1 year (up to 17 treatment cycles

Gemcitabine: Gemcitabine was provided as a solution for infusion.

Pertuzumab: Pertuzumab was provided as a single-use formulation for infusion.

Total Total of all reporting groups

Baseline Measures
    Placebo + Gemcitabine     Pertuzumab + Gemcitabine     Total  
Number of Participants  
[units: participants]
  65     65     130  
Age  
[units: years]
Mean (Standard Deviation)
  59.7  (11.94)     57.8  (10.79)     58.7  (11.38)  
Gender  
[units: participants]
     
Female     65     65     130  
Male     0     0     0  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Progression-free Survival   [ Time Frame: Baseline to the end of the study (up to 1 year) ]

2.  Secondary:   Percentage of Participants With an Objective Response   [ Time Frame: Baseline to the end of the study (up to 1 year) ]

3.  Secondary:   Duration of the Objective Response   [ Time Frame: Baseline to the end of the study (up to 1 year) ]

4.  Secondary:   Percentage of Participants Free From Disease Progression at 4 Months   [ Time Frame: Baseline to Month 4 ]

5.  Secondary:   Duration of Survival   [ Time Frame: Baseline to the end of the study (up to 1 year) ]


  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 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.


Results Point of Contact:  
Name/Title: Medical Communications
Organization: Genentech, Inc.
phone: 800 821-8590
e-mail: genentech@druginfo.com


No publications provided


Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00096993     History of Changes
Other Study ID Numbers: TOC3258g
Study First Received: November 17, 2004
Results First Received: May 26, 2015
Last Updated: June 8, 2015
Health Authority: United States: Food and Drug Administration