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Paclitaxel, Carboplatin, and Bevacizumab or Paclitaxel, Carboplatin, and Temsirolimus or Ixabepilone, Carboplatin, and Bevacizumab in Treating Patients With Stage III, Stage IV, or Recurrent Endometrial Cancer

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ClinicalTrials.gov Identifier: NCT00977574
Recruitment Status : Active, not recruiting
First Posted : September 15, 2009
Results First Posted : February 27, 2018
Last Update Posted : February 27, 2018
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Endometrial Adenocarcinoma
Endometrial Adenosquamous Carcinoma
Endometrial Clear Cell Adenocarcinoma
Endometrial Serous Adenocarcinoma
Recurrent Uterine Corpus Carcinoma
Stage IIIA Uterine Corpus Cancer
Stage IIIB Uterine Corpus Cancer
Stage IIIC Uterine Corpus Cancer
Stage IVA Uterine Corpus Cancer
Stage IVB Uterine Corpus Cancer
Interventions: Biological: Bevacizumab
Drug: Carboplatin
Drug: Ixabepilone
Other: Laboratory Biomarker Analysis
Drug: Paclitaxel
Drug: Temsirolimus

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Accrual of 349 patients from 48 main members and CCOP sites began on 9/14/2009 and completed on 01/09/2012 in 28 months; 5 months longer than expected. There were 11 patients deemed ineligible by central review most for reasons related to pathologic diagnosis. Ten patients refused all protocol treatment.

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 (Paclitaxel, Carboplatin, Bevacizumab) Paclitaxel 175 mg/m2 IV over 3 hours day 1 Carboplatin AUC = 6 IV day 1 Bevacizumab 15mg/kg IV day 1 (starting with cycle 2 for those patients who are entering post surgery) Maintenance regimen - Bevacizumab 15mg/kg IV every 21 days
Arm II (Paclitaxel, Carboplatin, Temsirolimus) Paclitaxel 175 mg/m2 IV over 3 hours day 1 Carboplatin AUC = 5 IV day 1 Temsirolimus 25 mg IV days 1 and 8 (starting with cycle 2 for those patients who are entering post surgery) Maintenance regimen – Temsirolimus 25 mg IV weekly days 1, 8 and 15 (one cycle = 21 days)
Arm III (Ixabepilone, Carboplatin, Bevacizumab) Ixabepilone 30 mg/m2 IV over 1 hour day 1 Carboplatin AUC = 6 IV day 1 Bevacizumab 15mg/kg IV day 1 (starting with cycle 2 for those patients who are entering post surgery) Maintenance regimen - Bevacizumab 15mg/kg IV every 21 days

Participant Flow:   Overall Study
    Arm I (Paclitaxel, Carboplatin, Bevacizumab)   Arm II (Paclitaxel, Carboplatin, Temsirolimus)   Arm III (Ixabepilone, Carboplatin, Bevacizumab)
STARTED   116   115   118 
COMPLETED   112   113   114 
NOT COMPLETED   4   2   4 
Never Treated                4                2                4 



  Baseline Characteristics

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.
All enrolled patients

Reporting Groups
  Description
Arm I (Paclitaxel, Carboplatin, Bevacizumab) Paclitaxel 175 mg/m2 IV over 3 hours day 1 Carboplatin AUC = 6 IV day 1 Bevacizumab 15mg/kg IV day 1 (starting with cycle 2 for those patients who are entering post surgery) Maintenance regimen - Bevacizumab 15mg/kg IV every 21 days
Arm II (Paclitaxel, Carboplatin, Temsirolimus) Paclitaxel 175 mg/m2 IV over 3 hours day 1 Carboplatin AUC = 5 IV day 1 Temsirolimus 25 mg IV days 1 and 8 (starting with cycle 2 for those patients who are entering post surgery) Maintenance regimen – Temsirolimus 25 mg IV weekly days 1, 8 and 15 (one cycle = 21 days)
Arm III (Ixabepilone, Carboplatin, Bevacizumab) Ixabepilone 30 mg/m2 IV over 1 hour day 1 Carboplatin AUC = 6 IV day 1 Bevacizumab 15mg/kg IV day 1 (starting with cycle 2 for those patients who are entering post surgery) Maintenance regimen - Bevacizumab 15mg/kg IV every 21 days
Total Total of all reporting groups

Baseline Measures
   Arm I (Paclitaxel, Carboplatin, Bevacizumab)   Arm II (Paclitaxel, Carboplatin, Temsirolimus)   Arm III (Ixabepilone, Carboplatin, Bevacizumab)   Total 
Overall Participants Analyzed 
[Units: Participants]
 116   115   118   349 
Age, Customized 
[Units: Participants]
Count of Participants
       
30-39 years      2   1.7%      2   1.7%      3   2.5%      7   2.0% 
40-49 years      6   5.2%      5   4.3%      8   6.8%      19   5.4% 
50-59 years      36  31.0%      35  30.4%      19  16.1%      90  25.8% 
60-69 years      48  41.4%      50  43.5%      57  48.3%      155  44.4% 
70-79 years      22  19.0%      22  19.1%      28  23.7%      72  20.6% 
>=80 years      2   1.7%      1   0.9%      3   2.5%      6   1.7% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      116 100.0%      115 100.0%      118 100.0%      349 100.0% 
Male      0   0.0%      0   0.0%      0   0.0%      0   0.0% 


  Outcome Measures

1.  Primary:   Number of Participants Who Progressed or Died by 25 Months From Enrollment   [ Time Frame: at 25 months ]

2.  Secondary:   Frequency and Severity of Toxicity as Assessed by CTCAE v3.0 for Each of the Three Arms.   [ Time Frame: Median of 10 cycles of treatment plus 30 days ]

3.  Secondary:   The Median Duration of Overall Survival for Each of the Three Arms.   [ Time Frame: Time from date of study entry to time of death or the date of last contact, assessed up to 5 years ]

4.  Secondary:   The Proportion of Patients With Measurable Disease Who Have Confirmed Objective Tumor Responses by Treatment.   [ Time Frame: Imaging was done every 3 cycles and at any other time clinically indicated. Imaging was required every 9 weeks until progression or initiation on non protocol therapy. After 2 years of protocol therapy or follow up, CT scan or MRI was every 3 months ]


  Serious Adverse Events


  Other Adverse Events


  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.


  More Information

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: Linda Gedeon for Virginia Filiaci, PhD
Organization: NRG Oncology
phone: 716-845-1169
e-mail: lgedeon@gogstats.org



Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00977574     History of Changes
Other Study ID Numbers: NCI-2011-01969
NCI-2011-01969 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000654472
GOG-0086P
GOG-0086P ( Other Identifier: NRG Oncology )
GOG-0086P ( Other Identifier: CTEP )
U10CA180868 ( U.S. NIH Grant/Contract )
U10CA027469 ( U.S. NIH Grant/Contract )
First Submitted: September 12, 2009
First Posted: September 15, 2009
Results First Submitted: October 20, 2017
Results First Posted: February 27, 2018
Last Update Posted: February 27, 2018