Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 9 for:    "Uterine Carcinosarcoma" | "Anti-Bacterial Agents"
Previous Study | Return to List | Next Study

Thalidomide in Treating Patients With Recurrent or Persistent Carcinosarcoma of the Uterus

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: NCT00025506
Recruitment Status : Completed
First Posted : January 27, 2003
Results First Posted : May 27, 2015
Last Update Posted : July 24, 2019
Sponsor:
Collaborator:
Gynecologic Oncology Group
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Recurrent Uterine Corpus Sarcoma
Uterine Carcinosarcoma
Interventions Other: Laboratory Biomarker Analysis
Drug: Thalidomide
Enrollment 55
Recruitment Details The study was activated on 9/4/2001 and closed to accrual on 3/3/2008 (suspended from 6/30/2003 to 8/1/2005).
Pre-assignment Details  
Arm/Group Title Thalidomide
Hide Arm/Group Description Thalidomide 200 mg PO once a day initial dose (each 28-day period will be considered one cycle). Dose increased by 200 mg every 2 weeks to maximum dose of 1000 mg/day until disease progression or adverse effects prohibit further therapy.
Period Title: Overall Study
Started 55
Completed 45 [1]
Not Completed 10
Reason Not Completed
Ineligible: clerical error             1
Ineligible: wrong cell type             5
Ineligible: inadequate pathology             2
Never Treated             2
[1]
Eligible and treated patients.
Arm/Group Title Thalidomide
Hide Arm/Group Description Thalidomide 200 mg PO once a day initial dose (each 28-day period will be considered one cycle). Dose increased by 200 mg every 2 weeks to maximum dose of 1000 mg/day until disease progression or adverse effects prohibit further therapy.
Overall Number of Baseline Participants 45
Hide Baseline Analysis Population Description
Eligible and treated patients.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 45 participants
65.6  (8.9)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 45 participants
30-39 years 1
40-49 years 1
50-59 years 7
60-69 years 23
70-79 years 11
80-89 years 2
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants
Female
45
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 45 participants
45
Histologic type  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 45 participants
Carcinosarcoma-homologous 22
Carcinosarcoma-heterologous 16
Carcinosarcoma, MMT 7
1.Primary Outcome
Title Progression-free Survival (PFS) > 6 Months
Hide Description Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.
Time Frame Every other cycle for 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and treated patients.
Arm/Group Title Thalidomide
Hide Arm/Group Description:
Thalidomide 200 mg PO once a day initial dose (each 28-day period will be considered one cycle). Dose increased by 200 mg every 2 weeks to maximum dose of 1000 mg/day until disease progression or adverse effects prohibit further therapy.
Overall Number of Participants Analyzed 45
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
17.8
(9 to 30)
2.Primary Outcome
Title Frequency and Severity of Adverse Effects as Assessed by Common Toxicity Criteria (CTC) v2.0
Hide Description [Not Specified]
Time Frame Each cycle during treatment and 30 days after the last treatment (average 4 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and evaluable patients
Arm/Group Title Grade 0 Grade 1 Grade 2 Grade 3 Grade 4
Hide Arm/Group Description:
Number of patients who did not experience the adverse event.
Number of patients who experienced a Grade 1 adverse event (Common Toxicity Criteria version 2)
Number of patients who experienced a Grade 2 adverse event (Common Toxicity Criteria version 2)
Number of patients who experienced a Grade 3 adverse event (Common Toxicity Criteria version 2)
Number of patients who experienced a Grade 4 adverse event (Common Toxicity Criteria version 2)
Overall Number of Participants Analyzed 45 45 45 45 45
Measure Type: Count of Participants
Unit of Measure: Participants
Nausea
31
  68.9%
4
   8.9%
6
  13.3%
4
   8.9%
0
   0.0%
Vomiting
36
  80.0%
4
   8.9%
4
   8.9%
1
   2.2%
0
   0.0%
Constipation
27
  60.0%
6
  13.3%
9
  20.0%
3
   6.7%
0
   0.0%
Anorexia
42
  93.3%
2
   4.4%
1
   2.2%
0
   0.0%
0
   0.0%
Fatigue
22
  48.9%
5
  11.1%
15
  33.3%
3
   6.7%
0
   0.0%
Neutropenia
41
  91.1%
1
   2.2%
3
   6.7%
0
   0.0%
0
   0.0%
Thrombocytopenia
44
  97.8%
1
   2.2%
0
   0.0%
0
   0.0%
0
   0.0%
Anemia
22
  48.9%
9
  20.0%
9
  20.0%
4
   8.9%
1
   2.2%
Cardiovascular
31
  68.9%
9
  20.0%
2
   4.4%
1
   2.2%
2
   4.4%
Neuropathy (sensory)
27
  60.0%
12
  26.7%
5
  11.1%
1
   2.2%
0
   0.0%
Other neurologic
31
  68.9%
2
   4.4%
6
  13.3%
6
  13.3%
0
   0.0%
Dermatologic
39
  86.7%
4
   8.9%
2
   4.4%
0
   0.0%
0
   0.0%
Metabolic
40
  88.9%
3
   6.7%
0
   0.0%
2
   4.4%
0
   0.0%
Pain
38
  84.4%
4
   8.9%
2
   4.4%
1
   2.2%
0
   0.0%
3.Secondary Outcome
Title Progression Free Survival
Hide Description Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.
Time Frame Every other cycle until progression or death, up to 5 years.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and treated patients
Arm/Group Title Thalidomide
Hide Arm/Group Description:
Thalidomide 200 mg PO once a day initial dose (each 28-day period will be considered one cycle). Dose increased by 200 mg every 2 weeks to maximum dose of 1000 mg/day until disease progression or adverse effects prohibit further therapy.
Overall Number of Participants Analyzed 45
Median (Inter-Quartile Range)
Unit of Measure: months
1.91
(1.35 to 4.17)
4.Secondary Outcome
Title Tumor Response
Hide Description RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.
Time Frame For those patients whose disease can be evaluated by physical examination, response was assessed prior to each 28-day cycle. CT scan or MRI if used to follow lesion for measurable disease every other cycle. (average = 4 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and treated patients.
Arm/Group Title Thalidomide
Hide Arm/Group Description:
Thalidomide 200 mg PO once a day initial dose (each 28-day period will be considered one cycle). Dose increased by 200 mg every 2 weeks to maximum dose of 1000 mg/day until disease progression or adverse effects prohibit further therapy.
Overall Number of Participants Analyzed 45
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
4.4
(1 to 13)
5.Secondary Outcome
Title Overall Survival
Hide Description The observed length of life from entry into the study to death or the date of last contact.
Time Frame From study entry to death or last contact, up to 5 years.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and treated patients.
Arm/Group Title Thalidomide
Hide Arm/Group Description:
Thalidomide 200 mg PO once a day initial dose (each 28-day period will be considered one cycle). Dose increased by 200 mg every 2 weeks to maximum dose of 1000 mg/day until disease progression or adverse effects prohibit further therapy.
Overall Number of Participants Analyzed 45
Median (95% Confidence Interval)
Unit of Measure: months
5.9
(3.6 to 9.6)
6.Secondary Outcome
Title Initial Performance Status
Hide Description

Performance status 0 = Fully active, able to carry on all pre-disease performance without restriction.

Performance status 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of light or sedentary nature, e.g., light housework, office work.

Performance status 2 = Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours.

Time Frame baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and evaluable patients
Arm/Group Title Thalidomide
Hide Arm/Group Description:
Thalidomide 200 mg PO once a day initial dose (each 28-day period will be considered one cycle). Dose increased by 200 mg every 2 weeks to maximum dose of 1000 mg/day until disease progression or adverse effects prohibit further therapy.
Overall Number of Participants Analyzed 45
Measure Type: Count of Participants
Unit of Measure: Participants
Performance status = 0
30
  66.7%
Performance status = 1
12
  26.7%
Performance status = 2
3
   6.7%
7.Secondary Outcome
Title Initial Histologic Grade
Hide Description G3 - Predominantly solid or entirely undifferentiated carcinoma. Not graded - tumor grade not reported.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and evaluable patients
Arm/Group Title Thalidomide
Hide Arm/Group Description:
Thalidomide 200 mg PO once a day initial dose (each 28-day period will be considered one cycle). Dose increased by 200 mg every 2 weeks to maximum dose of 1000 mg/day until disease progression or adverse effects prohibit further therapy.
Overall Number of Participants Analyzed 45
Measure Type: Count of Participants
Unit of Measure: Participants
Grade 3
4
   8.9%
Not graded
41
  91.1%
8.Other Pre-specified Outcome
Title Serum and Plasma Concentrations of VEGF and bFGF With PFS
Hide Description [Not Specified]
Time Frame Up to 5 years
Outcome Measure Data Not Reported
9.Other Pre-specified Outcome
Title Serum and Plasma Concentrations of Vascular Endothelial Growth Factor (VEGF) and bFGF
Hide Description [Not Specified]
Time Frame Up to 5 years
Outcome Measure Data Not Reported
Time Frame All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Thalidomide
Hide Arm/Group Description Thalidomide 200 mg PO once a day initial dose (each 28-day period will be considered one cycle). Dose increased by 200 mg every 2 weeks to maximum dose of 1000 mg/day until disease progression or adverse effects prohibit further therapy.
All-Cause Mortality
Thalidomide
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Thalidomide
Affected / at Risk (%)
Total   15/45 (33.33%) 
Cardiac disorders   
Thrombosis Embolism * 1  2/45 (4.44%) 
Gastrointestinal disorders   
Constipation * 1  1/45 (2.22%) 
Dehydration * 1  1/45 (2.22%) 
Nausea * 1  2/45 (4.44%) 
Gi Other * 1  1/45 (2.22%) 
General disorders   
Constitutional Symptoms Other * 1  5/45 (11.11%) 
Hepatobiliary disorders   
Bilirubin * 1  1/45 (2.22%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea * 1  3/45 (6.67%) 
Vascular disorders   
Hemorrhage With Grade 3/4 Thrombocytopenia * 1  1/45 (2.22%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (2.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Thalidomide
Affected / at Risk (%)
Total   45/45 (100.00%) 
Blood and lymphatic system disorders   
Neutropenia * 1  4/45 (8.89%) 
Thrombocytopenia * 1  2/45 (4.44%) 
Lymphopenia * 1  1/45 (2.22%) 
Leukopenia * 1  6/45 (13.33%) 
Transfusion Prbc's * 1  7/45 (15.56%) 
Anemia * 1  29/45 (64.44%) 
Transfusion Platelets * 1  1/45 (2.22%) 
Lymphatics * 1  3/45 (6.67%) 
Cardiac disorders   
Arrhythmia Nodal/Junctional Dysrhythmia * 1  1/45 (2.22%) 
Edema * 1  12/45 (26.67%) 
Thrombosis Embolism * 1  2/45 (4.44%) 
Palpitations * 1  1/45 (2.22%) 
Ear and labyrinth disorders   
Inner Ear/Hearing * 1  1/45 (2.22%) 
Endocrine disorders   
Hot Flashes/Flushes * 1  2/45 (4.44%) 
Eye disorders   
Ocular Other * 1  1/45 (2.22%) 
Dry Eye * 1  2/45 (4.44%) 
Vision Flashing Lights/Floaters * 1  1/45 (2.22%) 
Vision Blurred * 1  1/45 (2.22%) 
Gastrointestinal disorders   
Anorexia * 1  4/45 (8.89%) 
Flatulence * 1  1/45 (2.22%) 
Diarrhea With Colostomy * 1  1/45 (2.22%) 
Mouth Dryness * 1  4/45 (8.89%) 
Ascites Non-Malignant * 1  4/45 (8.89%) 
Taste Disturbance * 1  1/45 (2.22%) 
Diarrhea Without Colostomy * 1  6/45 (13.33%) 
Constipation * 1  20/45 (44.44%) 
Stomatitis/Pharyngitis * 1  2/45 (4.44%) 
Dehydration * 1  3/45 (6.67%) 
Vomiting * 1  12/45 (26.67%) 
Nausea * 1  16/45 (35.56%) 
Gi Other * 1  5/45 (11.11%) 
General disorders   
Fever(No Neutropenia) * 1  2/45 (4.44%) 
Weight Gain(No Vod) * 1  1/45 (2.22%) 
Constitutional Symptoms Other * 1  2/45 (4.44%) 
Sweating * 1  1/45 (2.22%) 
Fatigue * 1  24/45 (53.33%) 
Abdominal Pain * 1  7/45 (15.56%) 
Pain Other * 1  4/45 (8.89%) 
Pain Tumor * 1  1/45 (2.22%) 
Headache * 1  6/45 (13.33%) 
Pelvic Pain * 1  1/45 (2.22%) 
Chest Pain * 1  2/45 (4.44%) 
Bone Pain * 1  2/45 (4.44%) 
Arthralgia * 1  4/45 (8.89%) 
Myalgia * 1  2/45 (4.44%) 
Pain Rectal/Perirectal * 1  1/45 (2.22%) 
Hepatobiliary disorders   
Hepatic Other * 1  1/45 (2.22%) 
Hypoalbuminemia * 1  4/45 (8.89%) 
Sgot(Ast) * 1  1/45 (2.22%) 
Alkaline Phosphatase * 1  3/45 (6.67%) 
Bilirubin * 1  2/45 (4.44%) 
Infections and infestations   
Infection Without Neutropenia * 1  3/45 (6.67%) 
Metabolism and nutrition disorders   
Hypophosphatemia * 1  1/45 (2.22%) 
Metabolic Other * 1  3/45 (6.67%) 
Hyponatremia * 1  2/45 (4.44%) 
Hypernatremia * 1  1/45 (2.22%) 
Hypocalcemia * 1  2/45 (4.44%) 
Hypermagnesemia * 1  2/45 (4.44%) 
Hyperglycemia * 1  4/45 (8.89%) 
Hypokalemia * 1  2/45 (4.44%) 
Hypomagnesmia * 1  3/45 (6.67%) 
Musculoskeletal and connective tissue disorders   
Muscle Weakness * 1  1/45 (2.22%) 
Nervous system disorders   
Tremor * 1  1/45 (2.22%) 
Hallucinations * 1  1/45 (2.22%) 
Depressed Level Of Consciousness * 1  8/45 (17.78%) 
Cognitive Disturbance * 1  1/45 (2.22%) 
Ataxia(Incoordination) * 1  2/45 (4.44%) 
Mood Alteration Anxiety/Agitation * 1  1/45 (2.22%) 
Insomnia * 1  3/45 (6.67%) 
Dizziness * 1  7/45 (15.56%) 
Mood Alteration Depression * 1  3/45 (6.67%) 
Neuropathy Sensor * 1  19/45 (42.22%) 
Renal and urinary disorders   
Urinary Frequency/Urgency * 1  2/45 (4.44%) 
Creatinine * 1  4/45 (8.89%) 
Renal/Gu Other * 1  2/45 (4.44%) 
Vaginitis No Infection * 1  1/45 (2.22%) 
Urinary Retention * 1  1/45 (2.22%) 
Ureteral Obstruction * 1  1/45 (2.22%) 
Respiratory, thoracic and mediastinal disorders   
Pulmonary Other * 1  1/45 (2.22%) 
Cough * 1  2/45 (4.44%) 
Pneumonitis/Pulmonary Infiltrates * 1  1/45 (2.22%) 
Dyspnea * 1  11/45 (24.44%) 
Skin and subcutaneous tissue disorders   
Alopecia * 1  1/45 (2.22%) 
Rash Desquamation * 1  3/45 (6.67%) 
Bruising * 1  1/45 (2.22%) 
Dry Skin * 1  2/45 (4.44%) 
Vascular disorders   
Rectal Bleeding/Hematochezia * 1  1/45 (2.22%) 
Epistaxis * 1  1/45 (2.22%) 
Vaginal Bleeding * 1  2/45 (4.44%) 
Hematuria No Vaginal Bleeding * 1  2/45 (4.44%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (2.0)
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Angela M. Kuras, Associate Director of Data Management
Organization: NRG Oncology Statistics and Data Management Center - Buffalo
Phone: 716-845-7733
EMail: kurasa@nrgoncology.org
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00025506     History of Changes
Other Study ID Numbers: NCI-2012-02421
NCI-2012-02421 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000068967
GOG-0230B ( Other Identifier: Gynecologic Oncology Group )
GOG-0230B ( Other Identifier: CTEP )
U10CA027469 ( U.S. NIH Grant/Contract )
First Submitted: October 11, 2001
First Posted: January 27, 2003
Results First Submitted: May 7, 2015
Results First Posted: May 27, 2015
Last Update Posted: July 24, 2019