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Doxorubicin Hydrochloride, Cisplatin, and Paclitaxel or Carboplatin and Paclitaxel in Treating Patients With Stage III-IV or Recurrent Endometrial Cancer

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ClinicalTrials.gov Identifier: NCT00063999
Recruitment Status : Active, not recruiting
First Posted : July 9, 2003
Results First Posted : April 23, 2018
Last Update Posted : April 23, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gynecologic Oncology Group

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: 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: Drug: Carboplatin
Drug: Cisplatin
Drug: Doxorubicin Hydrochloride
Biological: Filgrastim
Other: Laboratory Biomarker Analysis
Drug: Paclitaxel
Biological: Pegfilgrastim
Other: Quality-of-Life Assessment

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
GOG 0209 accrued 1381 patients from August 2003 to April 2009. 1312 of these patients were eligible.

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
Doxorubicin, Cisplatin, Paclitaxel Patients receive doxorubicin IV over approximately 15-30 minutes on day 1, cisplatin IV over 60-90 minutes on day 1, paclitaxel IV over 3 hours on day 2, and filgrastim SC on days 3-12 or pegfilgrastim SC on day 3. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.
Paclitaxel, Carboplatin Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.

Participant Flow:   Overall Study
    Doxorubicin, Cisplatin, Paclitaxel   Paclitaxel, Carboplatin
STARTED   692   689 
COMPLETED   647   665 
NOT COMPLETED   45   24 
Withdrawal by Subject                1                0 
Ineligible                44                24 



  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.
Eligible and treated patients

Reporting Groups
  Description
Arm I (Doxorubicin Hydrochloride, Cisplatin, Paclitaxel) Patients receive doxorubicin hydrochloride IV over approximately 15-30 minutes on day 1, cisplatin IV over 60-90 minutes on day 1, paclitaxel IV over 3 hours on day 2, and filgrastim SC on days 3-12 or pegfilgrastim SC on day 3. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.
Arm II (Paclitaxel, Carboplatin) Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.
Total Total of all reporting groups

Baseline Measures
   Arm I (Doxorubicin Hydrochloride, Cisplatin, Paclitaxel)   Arm II (Paclitaxel, Carboplatin)   Total 
Overall Participants Analyzed 
[Units: Participants]
 647   665   1312 
Age, Customized 
[Units: Participants]
Count of Participants
     
<40 years      19   2.9%      18   2.7%      37   2.8% 
40 -49 years      67  10.4%      70  10.5%      137  10.4% 
50-59 years      192  29.7%      219  32.9%      411  31.3% 
60-60 years      256  39.6%      244  36.7%      500  38.1% 
>=70 years      113  17.5%      114  17.1%      227  17.3% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      647 100.0%      665 100.0%      1312 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 


  Outcome Measures

1.  Primary:   Number of Participants Alive at Time of Last Follow-up.   [ Time Frame: Patients were assessed during treatment. Following completion of treatment, follow up was assessed every 3 months for 2 years, then every 6 months for 3 years and annually after for a maximum of 10 years. ]

2.  Secondary:   Patient-reported Neurotoxicity (Ntx) as Measured by the FACT/GOG-Ntx Subscale (Short)   [ Time Frame: Baseline, 6 weeks post treatment start, 15 weeks post treatment start and 26 weeks post treatment start ]

3.  Secondary:   Patient Reported Quality of Life as Measured With the Combination of Physical Well-being (PWB) Subscale and Functional Well-being (FWB) Subscale From the FACT-G   [ Time Frame: Pre-treatment, 6 weeks post starting treatment (prior to cycle 3), 15 weeks post starting treatment (prior to cycle 6), 26 weeks post starting treatment ]

4.  Secondary:   Number of Participants Alive at Time of Last Follow-up by Estrogen or Progesterone Receptor Status (Positive or Negative)   [ Time Frame: Patients were assessed during treatment. Following completion of treatment, follow up was assessed every 3 months for 2 years, then every 6 months for 3 years and annually thereafter, for a maximum of 10 years. ]

5.  Secondary:   Number of Participants With Indicated Severity of CTCAE v2 Graded Neurotoxicity and Infection   [ Time Frame: Assessed throughout the treatment period and for 30 days after discontinuation of treatment. ]


  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
Eligibility for this study was expanded from measurable, stage 3 or stage 4 or recurrent disease to include non-measurable, stage 4 or recurrent disease and then to include non-measurable stage 3 disease.


  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: 716-545-8321
e-mail: lgedeon@gogstats.org



Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT00063999     History of Changes
Other Study ID Numbers: GOG-0209
NCI-2009-00584 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000305940
GOG-0209 ( Other Identifier: NRG Oncology )
GOG-0209 ( Other Identifier: CTEP )
U10CA180868 ( U.S. NIH Grant/Contract )
U10CA027469 ( U.S. NIH Grant/Contract )
First Submitted: July 8, 2003
First Posted: July 9, 2003
Results First Submitted: January 24, 2018
Results First Posted: April 23, 2018
Last Update Posted: April 23, 2018