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Trial record 1 of 1 for:    GOG 0262
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Paclitaxel and Carboplatin With or Without Bevacizumab in Treating Patients With Stage II, Stage III, or Stage IV Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01167712
Recruitment Status : Active, not recruiting
First Posted : July 22, 2010
Results First Posted : January 23, 2018
Last Update Posted : January 23, 2018
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Fallopian Tube Endometrioid Adenocarcinoma
Fallopian Tube Mucinous Adenocarcinoma
Fallopian Tube Transitional Cell Carcinoma
Malignant Ovarian Mixed Epithelial Tumor
Ovarian Brenner Tumor
Ovarian Clear Cell Adenocarcinofibroma
Ovarian Endometrioid Adenocarcinoma
Ovarian Mucinous Adenocarcinoma
Ovarian Serous Adenocarcinoma
Ovarian Transitional Cell Carcinoma
Primary Peritoneal Serous Adenocarcinoma
Stage IIA Fallopian Tube Cancer
Stage IIA Ovarian Cancer
Stage IIB Fallopian Tube Cancer
Stage IIB Ovarian Cancer
Stage IIC Fallopian Tube Cancer
Stage IIC Ovarian Cancer
Stage IIIA Fallopian Tube Cancer
Stage IIIA Ovarian Cancer
Stage IIIA Primary Peritoneal Cancer
Stage IIIB Fallopian Tube Cancer
Stage IIIB Ovarian Cancer
Stage IIIB Primary Peritoneal Cancer
Stage IIIC Fallopian Tube Cancer
Stage IIIC Ovarian Cancer
Stage IIIC Primary Peritoneal Cancer
Stage IV Fallopian Tube Cancer
Stage IV Ovarian Cancer
Stage IV Primary Peritoneal Cancer
Undifferentiated Ovarian Carcinoma
Interventions: Biological: Bevacizumab
Drug: Carboplatin
Procedure: Computed Tomography
Drug: Paclitaxel
Procedure: Therapeutic Conventional Surgery

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Newly diagnosed women with high-risk early stage or advanced stage epithelial ovarian cancer enrolled from September 27, 2010 to February 8, 2012.These women were randomly assigned to receive either carboplatin (AUC 6) combined with either paclitaxel 175 mg/m2 q 21 days or paclitaxel 80mg/m2 on days 1, 8 and 15. Bevacizumab was optional.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
112 additional women, whose treatment was not randomized, enrolled onto this study in order to evaluate whether findings from perfusion imaging are prognostic. This report focuses on the randomized treatment component of this study.

Reporting Groups
  Description
Arm I (Adjuvant Chemotherapy Suboptimally Debulked)

Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses.

Bevacizumab: Given IV

Carboplatin: Given IV

Computed Tomography: Correlative studies

Paclitaxel: Given IV

Arm II (Neoadjuvant Chemotherapy)

Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses. Patients undergo interval cytoreductive surgery between courses 3 and 4.

Bevacizumab: Given IV

Carboplatin: Given IV

Computed Tomography: Correlative studies

Paclitaxel: Given IV

Therapeutic Conventional Surgery: Undergo surgery


Participant Flow:   Overall Study
    Arm I (Adjuvant Chemotherapy Suboptimally Debulked)   Arm II (Neoadjuvant Chemotherapy)
STARTED   346   346 
COMPLETED   346   346 
NOT COMPLETED   0   0 



  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.
Newly diagnosed women with high-risk early stage or advanced stage epithelial ovarian cancer.

Reporting Groups
  Description
Arm I (Adjuvant Chemotherapy Suboptimally Debulked)

Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses.

Bevacizumab: Given IV

Carboplatin: Given IV

Computed Tomography: Correlative studies

Paclitaxel: Given IV

Therapeutic Conventional Surgery: Undergo surgery

Arm II (Neoadjuvant Chemotherapy)

Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses. Patients undergo interval cytoreductive surgery between courses 3 and 4.

Bevacizumab: Given IV

Carboplatin: Given IV

Computed Tomography: Correlative studies

Paclitaxel: Given IV

Therapeutic Conventional Surgery: Undergo surgery

Total Total of all reporting groups

Baseline Measures
   Arm I (Adjuvant Chemotherapy Suboptimally Debulked)   Arm II (Neoadjuvant Chemotherapy)   Total 
Overall Participants Analyzed 
[Units: Participants]
 346   346   692 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      214  61.8%      217  62.7%      431  62.3% 
>=65 years      132  38.2%      129  37.3%      261  37.7% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      346 100.0%      346 100.0%      692 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
Canada   1   0   1 
United States   345   345   690 
South Korea   0   1   1 


  Outcome Measures

1.  Primary:   Progression-Free Survival   [ Time Frame: The timeframe is from enrollment onto the study up to 3 years following enrollment. ]

2.  Secondary:   Median Duration of First Quartile Survival   [ Time Frame: The timeframe is from enrollment onto the study up to 3 years after enrollment ]

3.  Secondary:   Quality of Life Score as Measured by Functional Assessment of Cancer Therapy-Ovary-Total Outcome Index (Fact-O TOI)   [ Time Frame: 18 weeks after enrolling on the study, which is the time it takes to complete 6 cycles of treatment plus 3 weeks ]

4.  Other Pre-specified:   Changes in the Tumor Perfusion Parameters as Quantified by Vascularity or Blood Volume; Perfusion or Blood Flow; Mean Transit Time; and Microvascular Permeability or Permeability Surface Area Product   [ Time Frame: Baseline (T0) up to 10 days after the start of course 2 (T2) ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  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 Mark Brady, PhD.
Organization: NRG Oncology
phone: 716-845-1169
e-mail: lgedeon@gogstats.org


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01167712     History of Changes
Other Study ID Numbers: NCI-2011-03812
NCI-2011-03812 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
ACRIN 6695
CDR0000681448
GOG-0262/ACRIN 6695 ( Other Identifier: NRG Oncology )
GOG-0262 ( Other Identifier: CTEP )
U10CA180868 ( U.S. NIH Grant/Contract )
U10CA027469 ( U.S. NIH Grant/Contract )
First Submitted: July 21, 2010
First Posted: July 22, 2010
Results First Submitted: October 2, 2017
Results First Posted: January 23, 2018
Last Update Posted: January 23, 2018