Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Carboplatin, Docetaxel, and Radiation Therapy in Treating Patients With Stage III/IV, or Recurrent Endometrial 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: NCT00258362
Recruitment Status : Completed
First Posted : November 24, 2005
Results First Posted : November 11, 2010
Last Update Posted : December 28, 2017
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Endometrial Cancer
Interventions Drug: carboplatin
Drug: docetaxel
Radiation: radiation therapy
Enrollment 41
Recruitment Details 42 patients consented originally, but 1 patient withdrew consent before receiving any treatment.
Pre-assignment Details  
Arm/Group Title Patients With Endometrial Cancer
Hide Arm/Group Description Patients with advanced or recurrent endometrial cancer receiving treatment with induction docetaxel/carboplatin, radiation (4500 cGy) and followed by 3 courses of consolidation docetaxel/carboplatin.
Period Title: Overall Study
Started 41
Completed 41
Not Completed 0
Arm/Group Title Patients With Endometrial Cancer
Hide Arm/Group Description Patients with advanced or recurrent endometrial cancer receiving treatment with induction docetaxel/carboplatin, radiation (4500 cGy) and followed by 3 courses of consolidation docetaxel/carboplatin. This group excludes those patients with recurrent endometrial cancer.
Overall Number of Baseline Participants 41
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants
<=18 years
0
   0.0%
Between 18 and 65 years
30
  73.2%
>=65 years
11
  26.8%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 41 participants
59.0  (11.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants
Female
41
 100.0%
Male
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 41 participants
White 35
Black 1
Hispanic 2
Other 2
Unknown 1
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 41 participants
41
Histology   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 41 participants
Endometroid 32
Serous 4
Mucinous 1
Adenosquamous 3
Endometroid + Serous 1
[1]
Measure Description: Type or classification of cancer
1.Primary Outcome
Title Percent of Patients Estimated to be Progression-Free and Alive
Hide Description This estimate was determined by using a statistical method of analysis (Kaplan-Meier).
Time Frame 1 Year, 2 Years, 3 Years
Hide Outcome Measure Data
Hide Analysis Population Description
Two patients with recurrent disease at study entry were excluded from this analysis.
Arm/Group Title Patients With Endometrial Cancer
Hide Arm/Group Description:
Patients with advanced endometrial cancer receiving treatment with induction docetaxel/carboplatin, radiation (4500 cGy) and followed by 3 courses of consolidation docetaxel/carboplatin.
Overall Number of Participants Analyzed 39
Measure Type: Number
Unit of Measure: Percentage of Patients
1 Year 86
2 Years 76
3 Years 68
2.Secondary Outcome
Title Percent of Patients Estimated to be Alive
Hide Description This estimate of overall survival was determined by using the statistical method (Kaplan-Meier) of analysis.
Time Frame 1 Year, 2 Years, 3 Years
Hide Outcome Measure Data
Hide Analysis Population Description
All 41 patients were included in this analysis.
Arm/Group Title Patients With Endometrial Cancer
Hide Arm/Group Description:
Patients with advanced or recurrent endometrial cancer receiving treatment with induction docetaxel/carboplatin, radiation (4500 cGy) and followed by 3 courses of consolidation docetaxel/carboplatin.
Overall Number of Participants Analyzed 41
Measure Type: Number
Unit of Measure: Percentage of Patients
1 Year 94
2 Years 91
3 Years 80
Time Frame Serious, related adverse events and other adverse events were collected from day 1 of treatment to 30 days post-treatment. Deaths outside the collection timeframe were not reported.
Adverse Event Reporting Description Other adverse events were collected only once per patient (incidence); the number of events for each adverse event were not collected (frequency).
 
Arm/Group Title Patients With Endometrial Cancer
Hide Arm/Group Description Patients with advanced endometrial cancer receiving treatment with induction docetaxel/carboplatin, radiation (4500 cGy) and followed by 3 courses of consolidation docetaxel/carboplatin.
All-Cause Mortality
Patients With Endometrial Cancer
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Patients With Endometrial Cancer
Affected / at Risk (%) # Events
Total   8/41 (19.51%)    
Blood and lymphatic system disorders   
Lymphocele  1  1/41 (2.44%)  1
Gastrointestinal disorders   
Dehydration  1  2/41 (4.88%)  2
Nausea  1  1/41 (2.44%)  1
Vomiting  1  1/41 (2.44%)  1
Infections and infestations   
Blood Infection  1  1/41 (2.44%)  1
Febrile Neutropenia  1  1/41 (2.44%)  1
Renal and urinary disorders   
Bladder Infection  1  2/41 (4.88%)  2
Stricture/stenosis of ureter  1  1/41 (2.44%)  1
Respiratory, thoracic and mediastinal disorders   
Metastatic disease to lung  1 [1]  1/41 (2.44%)  1
Vascular disorders   
Thrombosis/embolism  1  1/41 (2.44%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
[1]
Resulted in death
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Patients With Endometrial Cancer
Affected / at Risk (%) # Events
Total   41/41 (100.00%)    
Blood and lymphatic system disorders   
Anemia  1  31/41 (75.61%) 
Hemorrhage  1  3/41 (7.32%) 
Leukopenia  1  24/41 (58.54%) 
Lymphatics  1  4/41 (9.76%) 
Neutropenia  1  21/41 (51.22%) 
Thrombocytopenia  1  20/41 (48.78%) 
Endocrine disorders   
Endocrine  1  7/41 (17.07%) 
Eye disorders   
Ocular, visual  1  3/41 (7.32%) 
Gastrointestinal disorders   
Anorexia  1  7/41 (17.07%) 
Constipation  1  20/41 (48.78%) 
Diarrhea  1  16/41 (39.02%) 
Vomiting  1  7/41 (17.07%) 
Weight loss  1  3/41 (7.32%) 
General disorders   
Fatigue  1  37/41 (90.24%) 
Fever  1  3/41 (7.32%) 
Pain  1  19/41 (46.34%) 
Infections and infestations   
Infection  1  5/41 (12.20%) 
Musculoskeletal and connective tissue disorders   
Musculoskeletal soft tissue  1  6/41 (14.63%) 
Nervous system disorders   
Neuropathy  1  9/41 (21.95%) 
Renal and urinary disorders   
Renal, genitourinary  1  4/41 (9.76%) 
Reproductive system and breast disorders   
Sexual reproductive function  1  4/41 (9.76%) 
Respiratory, thoracic and mediastinal disorders   
Pulmonary, upper respiratory  1  6/41 (14.63%) 
Skin and subcutaneous tissue disorders   
Dermatology  1  22/41 (53.66%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Melissa Geller, M.D.
Organization: Masonic Cancer Center, University of Minnesota
Phone: 612-626-3111
EMail: gelle005@umn.edu
Layout table for additonal information
Responsible Party: Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier: NCT00258362     History of Changes
Other Study ID Numbers: 2004LS021
UMN-WCC-38 ( Other Identifier: Women's Cancer Center, University of Minnesota )
13062 ( Other Identifier: Sanofi-Aventis Pharmaceuticals )
First Submitted: November 22, 2005
First Posted: November 24, 2005
Results First Submitted: August 20, 2010
Results First Posted: November 11, 2010
Last Update Posted: December 28, 2017