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TEACO: Taxotere, Eloxatin, Avastin in Cancer of the Ovary (TEACO)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00296816
First received: February 23, 2006
Last updated: July 20, 2012
Last verified: August 2011
Results First Received: June 18, 2012  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Ovarian Cancer
Interventions: Drug: Bevacizumab (Avastin®)
Drug: Docetaxel (Taxotere®)
Drug: Oxaliplatin (Eloxatin®)

  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
152 participants were screened for the study. 20 were screen failures. 132 participants met eligibity criteria and were treated with study medication.

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
Oxaliplatin/Docetaxel/Bevacizumab Participants with International Federation of Gynecology and Obstetrics (FIGO) stage IB through IV ovarian, primary peritoneal, or fallopian tube carcinoma treated with Oxaliplatin, Docetaxel, and Bevacizumab - 28 days after initial surgery

Participant Flow:   Overall Study
    Oxaliplatin/Docetaxel/Bevacizumab
STARTED   132 
COMPLETED   58 [1] 
NOT COMPLETED   74 
Disease Progression                37 
Adverse Event                18 
Investigator/Participant request                5 
Non-compliance                1 
Missing for end of treatment                4 
Progression based on CA-125 (biomarker)                2 
Poor performance status                1 
Relocation to Florida                1 
Noncompliance/decision to discontinue                1 
Urine protein/creatinine ratio delay                1 
Neuropathy/patient preference                1 
Proteinuria                1 
ineligibility due to radiation treatment                1 
[1] Completed study treatment for a minimum of three years



  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
Oxaliplatin/Docetaxel/Bevacizumab (Measurable Disease)

Participants with International Federation of Gynecology and Obstetrics (FIGO) stage IB through IV ovarian, primary peritoneal, or fallopian tube carcinoma treated with Oxaliplatin, Docetaxel, and Bevacizumab - 28 days after initial surgery, with a measurable disease at baseline.

Measurable disease was defined as having at least one lesion that could be accurately measured in at least one dimension.

Oxaliplatin/Docetaxel/Bevacizumab (Non-Measurable Disease)

Participants with International Federation of Gynecology and Obstetrics (FIGO) stage IB through IV ovarian, primary peritoneal, or fallopian tube carcinoma treated with Oxaliplatin, Docetaxel, and Bevacizumab - 28 days after initial surgery, who did not have a measurable disease at baseline.

Measurable disease was defined as having at least one lesion that could be accurately measured in at least one dimension.

Total Total of all reporting groups

Baseline Measures
   Oxaliplatin/Docetaxel/Bevacizumab (Measurable Disease)   Oxaliplatin/Docetaxel/Bevacizumab (Non-Measurable Disease)   Total 
Overall Participants Analyzed 
[Units: Participants]
 80   52   132 
Age 
[Units: Years]
Mean (Standard Deviation)
 57.5  (10.43)   60.9  (9.54)   58.8  (10.19) 
Gender 
[Units: Participants]
     
Female   80   52   132 
Male   0   0   0 
Primary Tumor Site 
[Units: Participants]
     
Ovary   65   45   110 
Fallopian tube   6   5   11 
Peritoneum   9   2   11 
FIGO stage at diagnosis [1] 
[Units: Participants]
     
Stage IB   0   0   0 
Stage IC   0   3   3 
Stage IIA   0   0   0 
Stage IIB   0   0   0 
Stage IIC   3   5   8 
Stage IIIA   3   2   5 
Stage IIIB   2   5   7 
Stage IIIC   57   32   89 
Stage IV   15   5   20 
[1]

Ovarian cancer staging at diagnosis was based on the International Federation of Gynecology and Obstetrics (FIGO).

  • Stage I is the least severe, where the tumor is restricted to the ovaries.
  • Stage II involves both ovaries and the pelvis.
  • Stage III involves the ovaries and has microscopically confirmed peritoneal metastasis outside the pelvis and/or regional lymph node (also includes liver capsule metastasis).
  • Stage IV involves distant metastasis beyond the peritoneal cavity.


  Outcome Measures
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1.  Primary:   Twelve-month Progression-free Survival (PFS) Rate in Participants   [ Time Frame: up to 12 months following treatment initiation ]

2.  Secondary:   Twenty Four-month Progression-free Survival (PFS) Rate in Participants   [ Time Frame: up to 24 months following treatment initiation ]

3.  Secondary:   Median Time to Progression-free Survival (PFS)   [ Time Frame: up to approximately 1300 days following treatment initiation ]

4.  Secondary:   Tumor Response Rate Based on Gynecologic Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST)   [ Time Frame: up to 12 months following treatment initiation ]

5.  Secondary:   Twelve-month Recurrence-free Survival (RFS) Rate in Participants With Non Measurable Disease at Baseline   [ Time Frame: up to 12 months following treatment initiation ]

6.  Secondary:   Median Time to Recurrence-free Survival (RFS) in Participants With Non-measurable Disease at Baseline   [ Time Frame: up to approximately 1500 days following treatment initiation ]

7.  Secondary:   CA-125 Response Rate   [ Time Frame: up to 12 months after treatment initiation ]

8.  Secondary:   Overall Survival Rate   [ Time Frame: up to up to approximately 1700 days after treatment initiation ]

9.  Secondary:   Median Overall Survival Time   [ Time Frame: up to approximately 1700 days after treatment initiation ]


  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
One site closed prematurely during the study. Every effort was made to collect, at minimum, any outstanding safety data for the participants at this site. As a result, participants from this site were included only in the safety analysis.


  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: Trial Trans[parency Team
Organization: Sanofi
e-mail: Contact_us@sanofi.com



Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00296816     History of Changes
Other Study ID Numbers: PM_L_0239
Study First Received: February 23, 2006
Results First Received: June 18, 2012
Last Updated: July 20, 2012
Health Authority: United States: Food and Drug Administration