We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Adjuvant Chemotherapy for High Risk Uterine Leiomyosarcoma

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: NCT00282087
Recruitment Status : Completed
First Posted : January 25, 2006
Results First Posted : December 1, 2014
Last Update Posted : December 1, 2014
Sponsor:
Information provided by (Responsible Party):
Sarcoma Alliance for Research through Collaboration

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Leiomyosarcoma
Uterine Neoplasm
Intervention Drug: gemcitabine, docetaxel, doxorubicin
Enrollment 47
Recruitment Details This was multi-center study open at 11 major medical centers across the United States.
Pre-assignment Details  
Arm/Group Title Women Treated With Adjuvant Regimen for High Risk Uterine LMS
Hide Arm/Group Description Gemcitabine 900 mg/m2 on days 1 and 8 intravenously over 90 minutes, followed by Docetaxel 75 mg/m2 on day 8 intravenously over 1 hour.
Period Title: Overall Study
Started 47
Completed 46 [1]
Not Completed 1
Reason Not Completed
Death             1
[1]
One patient died during cycle 1 of treatment because of infectious complications of AIDS.
Arm/Group Title Women Treated With Adjuvant Regimen for High Risk Uterine LMS
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 47
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 47 participants
<=18 years
0
   0.0%
Between 18 and 65 years
44
  93.6%
>=65 years
3
   6.4%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 47 participants
53  (16)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 47 participants
Female
47
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 47 participants
47
1.Primary Outcome
Title Two-year Progression-free Survival Among Women Treated With This Adjuvant Regimen for High Risk Uterine LMS
Hide Description [Not Specified]
Time Frame Every 3 months up to two years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Women Treated With Adjuvant Regimen for High Risk Uterine LMS
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 46
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
78
(67 to 91)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Women Treated With Adjuvant Regimen for High Risk Uterine LMS
Comments The primary endpoint is progression-free survival time, with progression defined as a patient having evidence of recurrent LMS on follow-up evaluation and CT scan. Futility monitoring will be based on the accumulating right-censored PFS time data. The monitoring rules will be based on a Bayesian model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.15
Comments [Not Specified]
Method Bayesian Posterior Probability
Comments [Not Specified]
Method of Estimation Estimation Parameter Two year PFS
Estimated Value 78
Confidence Interval (2-Sided) 95%
67 to 91
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Tolerability/Toxicity of This Regimen
Hide Description Unacceptable toxicity is defined as grade 3 or 4 non-hematologic toxicity events that are considered to be treatment-related, excluding alopecia and fatigue.
Time Frame Every 28 days during dosing and then every 3 months thereafter until patient comes off study
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Women Treated With Adjuvant Regimen for High Risk Uterine LMS
Hide Arm/Group Description:
Number of major toxicity events
Overall Number of Participants Analyzed 46
Measure Type: Number
Unit of Measure: number of major toxicity events
6
3.Secondary Outcome
Title Correlation Between Age and Tumor Response to Treatment (PFS)
Hide Description [Not Specified]
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Women Treated With Adjuvant Regimen for High Risk Uterine LMS
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 47
Median (Full Range)
Unit of Measure: years
53
(37 to 70)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Women Treated With Adjuvant Regimen for High Risk Uterine LMS
Comments Age correlation with progression-free survival for patients on study treatment.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Cox Proportional Hazards
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value -0.00269
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Correlation Between Menopausal Status at Diagnosis and Tumor Response to Treatment (PFS)
Hide Description [Not Specified]
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Women Treated With Adjuvant Regimen for High Risk Uterine LMS
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 47
Measure Type: Number
Unit of Measure: participants
Postmenopausal 43
Premenopausal 4
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Women Treated With Adjuvant Regimen for High Risk Uterine LMS
Comments Menopausal status at diagnosis correlation with progression-free survival for patients on study treatment.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Cox Proportional Hazards
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.02
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Correlation Between Uterine Serosal Involvement and Tumor Response to Treatment (PFS)
Hide Description AJCC Stage I: No serosal involvement AJCC Stage II: No serosal involement AJCC Stage III: Serosal only
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Women Treated With Adjuvant Regimen for High Risk Uterine LMS
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 47
Measure Type: Number
Unit of Measure: participants
AJCC Stage I 0
AJCC Stage II 6
AJCC Stage III 41
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Women Treated With Adjuvant Regimen for High Risk Uterine LMS
Comments Uterine serosal involvement correlation with progression-free survival for patients on study treatment.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Cox Proportional Hazards
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.101
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Correlation Between Mitotic Rate and Tumor Response to Treatment (PFS)
Hide Description Mitotic rate is measured in mitoses per 10 high-power fields
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Women Treated With Adjuvant Regimen for High Risk Uterine LMS
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 47
Median (Full Range)
Unit of Measure: mitoses per 10 high-power fields
18
(5 to 83)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Women Treated With Adjuvant Regimen for High Risk Uterine LMS
Comments Mitotic rate correlation with progression-free survival for patients on study treatment.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Cox Proportional Hazards
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value -0.00676
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Correlation Between Estrogen Receptor (ER) Status and Tumor Response to Treatment (PFS)
Hide Description [Not Specified]
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Only 38 of the 47 patients were evaluable
Arm/Group Title Women Treated With Adjuvant Regimen for High Risk Uterine LMS
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 38
Measure Type: Number
Unit of Measure: participants
Positive Status 24
Negative Status 14
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Women Treated With Adjuvant Regimen for High Risk Uterine LMS
Comments Estrogen receptor (ER) status correlation with progression-free survival for patients on study treatment.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Cox Proportional Hazards
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value -0.708
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Correlation Between Progesterone Receptor (PR) Status and Tumor Response to Treatment (PFS)
Hide Description [Not Specified]
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Only 38 of the 47 patients were evaluable
Arm/Group Title Women Treated With Adjuvant Regimen for High Risk Uterine LMS
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 38
Measure Type: Number
Unit of Measure: participants
Positive Status 19
Negative Status 19
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Women Treated With Adjuvant Regimen for High Risk Uterine LMS
Comments Progesterone receptor (PR) status correlation with progression-free survival for patients on study treatment.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Cox Proportional Hazards
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value -0.906
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Correlation Between 1988 FIGO Stage and Tumor Response to Treatment (PFS)
Hide Description Stage I: confined to the uterine corpus Stage II: confined to corpus and cervix Stage IIIA: serosa involvement only (disease could involve the uterine serosa, but patients must have had no other evidence of local spread)
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Women Treated With Adjuvant Regimen for High Risk Uterine LMS
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 47
Measure Type: Number
Unit of Measure: participants
FIFO Stage I 38
FIGO Stage II 7
FIGO Stage III 2
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Women Treated With Adjuvant Regimen for High Risk Uterine LMS
Comments 1988 FIGO Stage correlation with progression-free survival for patients on study treatment.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Cox Proportional Hazards
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.207
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Correlation Between Estrogen Receptor (ER) or Progesterone Receptor (PR) Positive and Tumor Response to Treatment (PFS)
Hide Description [Not Specified]
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Women Treated With Adjuvant Regimen for High Risk Uterine LMS
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 47
Measure Type: Number
Unit of Measure: participants
ER or PR Positive 33
ER and PR Negative 14
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Women Treated With Adjuvant Regimen for High Risk Uterine LMS
Comments Estrogen receptor (ER) or progesterone receptor (PR) positive correlation with progression-free survival for patients on study treatment.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Cox Proportional Hazards
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value -0.564
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Women Treated With Adjuvant Regimen for High Risk Uterine LMS
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
Women Treated With Adjuvant Regimen for High Risk Uterine LMS
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Women Treated With Adjuvant Regimen for High Risk Uterine LMS
Affected / at Risk (%) # Events
Total   9/47 (19.15%)    
Blood and lymphatic system disorders   
Neutropenia  2/47 (4.26%)  2
Blood clot  1/47 (2.13%)  1
Renal insufficiency  1/47 (2.13%)  1
Cardiac disorders   
Chest Pain  2/47 (4.26%)  2
Gastrointestinal disorders   
Perforation of bowel  1/47 (2.13%)  1
Colostomy Reversal  1/47 (2.13%)  1
Diarrhea  1/47 (2.13%)  1
General disorders   
Fever  1/47 (2.13%)  1
Infections and infestations   
Infection  1/47 (2.13%)  1
Injury, poisoning and procedural complications   
Hernia  1/47 (2.13%)  1
Investigations   
Neutrophils  2/47 (4.26%)  2
Bilirubin  1/47 (2.13%)  1
Platelets  1/47 (2.13%)  1
Respiratory, thoracic and mediastinal disorders   
Throat Pain  1/47 (2.13%)  1
Skin and subcutaneous tissue disorders   
Cellulitis  1/47 (2.13%)  1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 4%
Women Treated With Adjuvant Regimen for High Risk Uterine LMS
Affected / at Risk (%) # Events
Total   14/47 (29.79%)    
Endocrine disorders   
myelosuppression  14/47 (29.79%) 
Immune system disorders   
Hypersensitivity  10/47 (21.28%) 
Nervous system disorders   
neuropathy  3/47 (6.38%) 
Skin and subcutaneous tissue disorders   
Edema  2/47 (4.26%) 
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Research Project Manager
Organization: SARC
Phone: (734) 930-7600
EMail: sarc@sarctrials.org
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Sarcoma Alliance for Research through Collaboration
ClinicalTrials.gov Identifier: NCT00282087    
Other Study ID Numbers: SARC005
MSKCC05-128 ( Other Identifier: Memorial Sloan-Kettering Cancer Center )
First Submitted: January 24, 2006
First Posted: January 25, 2006
Results First Submitted: July 19, 2013
Results First Posted: December 1, 2014
Last Update Posted: December 1, 2014