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Trial record 1 of 1 for:    GOG 0240
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Paclitaxel and Cisplatin or Topotecan With or Without Bevacizumab in Treating Patients With Stage IVB, Recurrent, or Persistent Cervical Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00803062
First received: December 4, 2008
Last updated: April 15, 2016
Last verified: February 2015
Results First Received: December 15, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Cervical Adenocarcinoma
Cervical Adenosquamous Carcinoma
Cervical Squamous Cell Carcinoma
Recurrent Cervical Carcinoma
Stage IVB Cervical Cancer
Interventions: Biological: Bevacizumab
Drug: Cisplatin
Other: Laboratory Biomarker Analysis
Drug: Paclitaxel
Other: Quality-of-Life Assessment
Other: Questionnaire Administration
Drug: Topotecan Hydrochloride

  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
The study was activated on 4/6/2009 and closed to accrual on 1/3/2012.

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 and Cisplatin) Paclitaxel 135 mg/m2 IV over 24 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 1 Cycles repeated q21 days to progression/toxicity
Arm II (Paclitaxel, Cisplatin, Bevacizumab) Paclitaxel 135 mg/m2 IV over 24 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 Bevacizumab 15 mg/kg IV day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 Bevacizumab 15 mg/kg IV day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 1 Bevacizumab 15 mg/kg IV day 1 Cycles repeated q21 days to progression/toxicity
Arm III (Topotecan Hydrochloride and Paclitaxel) Paclitaxel 175 mg/m2 over 3 hrs on day 1 Topotecan 0.75 mg/m2 over 30 mins days 1-3 Cycles repeated q21 days to progression/toxicity
Arm IV (Topotecan Hydrochloride, Paclitaxel, Bevacizumab) Paclitaxel 175 mg/m2 over 3 hrs on day 1 Topotecan 0.75 mg/m2 over 30 mins days 1-3 Bevacizumab 15 mg/kg IV day 1 Cycles repeated q21 days to progression/toxicity

Participant Flow:   Overall Study
    Arm I (Paclitaxel and Cisplatin)   Arm II (Paclitaxel, Cisplatin, Bevacizumab)   Arm III (Topotecan Hydrochloride and Paclitaxel)   Arm IV (Topotecan Hydrochloride, Paclitaxel, Bevacizumab)
STARTED   114   115   111   112 
COMPLETED   114   115   111   112 
NOT COMPLETED   0   0   0   0 



  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.
All enrolled patients.

Reporting Groups
  Description
Arm I (Paclitaxel and Cisplatin) Paclitaxel 135 mg/m2 IV over 24 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 1 Cycles repeated q21 days to progression/toxicity
Arm II (Paclitaxel, Cisplatin, Bevacizumab) Paclitaxel 135 mg/m2 IV over 24 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 Bevacizumab 15 mg/kg IV day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 Bevacizumab 15 mg/kg IV day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 1 Bevacizumab 15 mg/kg IV day 1 Cycles repeated q21 days to progression/toxicity
Arm III (Topotecan Hydrochloride and Paclitaxel) Paclitaxel 175 mg/m2 over 3 hrs on day 1 Topotecan 0.75 mg/m2 over 30 mins days 1-3 Cycles repeated q21 days to progression/toxicity
Arm IV (Topotecan Hydrochloride, Paclitaxel, Bevacizumab) Paclitaxel 175 mg/m2 over 3 hrs on day 1 Topotecan 0.75 mg/m2 over 30 mins days 1-3 Bevacizumab 15 mg/kg IV day 1 Cycles repeated q21 days to progression/toxicity
Total Total of all reporting groups

Baseline Measures
   Arm I (Paclitaxel and Cisplatin)   Arm II (Paclitaxel, Cisplatin, Bevacizumab)   Arm III (Topotecan Hydrochloride and Paclitaxel)   Arm IV (Topotecan Hydrochloride, Paclitaxel, Bevacizumab)   Total 
Overall Participants Analyzed 
[Units: Participants]
 114   115   111   112   452 
Age, Customized 
[Units: Participants]
         
20-29 years   6   5   1   6   18 
30-39 years   25   27   30   12   94 
40-49 years   36   34   33   41   144 
50-59 years   27   28   24   37   116 
60-69 years   14   13   17   12   56 
70-79 years   5   5   5   4   19 
80-89 years   1   3   1   0   5 
Gender 
[Units: Participants]
         
Female   114   115   111   112   452 
Male   0   0   0   0   0 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Overall Survival   [ Time Frame: From entry into the study to death or the date of last contact, assessed up to 5 years ]

2.  Primary:   Progression-free Survival   [ Time Frame: From study entry until disease progression, death or date of last contact, assessed up to 5 years (During treatment: every 3 weeks if by physical exam, every 6 weeks by CXR, CT or MRI. In follow-up: quarterly for 2 years then semi-annually for 3 years) ]

3.  Primary:   Tumor Response   [ Time Frame: Every cycle (if assessed by physical exam), every other cycle (if assessed by imaging), after the final cycle, then every 3 months x 2 years, then every 6 months x 3 years up to 5 years. ]

4.  Primary:   Incidence of Adverse Events Assessed by National Cancer Institute CTCAE Version 3.0.   [ Time Frame: Up to 30 days after completion of study treatment ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

5.  Other Pre-specified:   Extent of Nicotine Dependence   [ Time Frame: Up to 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

6.  Other Pre-specified:   Health-related Quality of Life   [ Time Frame: Up to 9 months after course 1 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

7.  Other Pre-specified:   Levels of Angiogenesis Markers in Plasma   [ Time Frame: Up to 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

8.  Other Pre-specified:   Levels of Cell-free DNA in Plasma   [ Time Frame: Up to 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

9.  Other Pre-specified:   Levels of Tumor Measures of Angiogenesis   [ Time Frame: Up to 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

10.  Other Pre-specified:   Number of CTCs   [ Time Frame: Up to 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

11.  Other Pre-specified:   Prevalence of Active Smoking   [ Time Frame: Up to 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  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 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: Angela M. Kuras, Associate Director of Data Management
Organization: NRG Oncology Statistics and Data Center - Buffalo
phone: 716-845-7733
e-mail: kurasa@nrgoncology.org


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

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00803062     History of Changes
Other Study ID Numbers: NCI-2009-01084
NCI-2009-01084 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000628746
GOG-0240 ( Other Identifier: NRG Oncology )
GOG-0240 ( Other Identifier: CTEP )
U10CA180868 ( US NIH Grant/Contract Award Number )
U10CA027469 ( US NIH Grant/Contract Award Number )
Study First Received: December 4, 2008
Results First Received: December 15, 2015
Last Updated: April 15, 2016
Health Authority: United States: Food and Drug Administration