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Trabectedin in Treating Patients With Advanced, Persistent, or Recurrent Leiomyosarcoma of the Uterus

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ClinicalTrials.gov Identifier: NCT00379145
Recruitment Status : Completed
First Posted : September 21, 2006
Results First Posted : December 12, 2017
Last Update Posted : December 12, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
GOG Foundation ( Gynecologic Oncology Group )

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Sarcoma
Intervention Drug: trabectedin
Enrollment 20
Recruitment Details This trial was opened to patient entry on June 4, 2007 and was closed to accrual on November 3, 2008.
Pre-assignment Details  
Arm/Group Title Trabectidin
Hide Arm/Group Description Trabectedin 1.5 mg/m2 IV over 24 hours every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy
Period Title: Overall Study
Started 20
Completed [1] 20
Not Completed 0
[1]
Eligible and treated patients
Arm/Group Title Trabectidin
Hide Arm/Group Description Trabectedin 1.5 mg/m2 IV over 24 hours every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy
Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
Eligible and treated patients
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
<40 years
1
   5.0%
40-49 years
3
  15.0%
50-59 years
5
  25.0%
60-69 years
7
  35.0%
70-79 years
3
  15.0%
>79 years
1
   5.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
20
 100.0%
Male
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
American Indian or Alaska Native
1
   5.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
4
  20.0%
White
15
  75.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Number of Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.0
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 CT scan or MRI if used to follow lesion for measurable disease every other cycle until disease progression for up to 5 years.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and treated patients
Arm/Group Title Trabectidin
Hide Arm/Group Description:
Trabectedin 1.5 mg/m2 IV over 24 hours every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy
Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: participants
Partial response 2
Complete response 0
2.Primary Outcome
Title Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
Hide Description [Not Specified]
Time Frame Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and treated patients
Arm/Group Title Grade 0 Grade 1 (CTCAE v 3.0) Grade 2 (CTCAE v 3.0) Grade 3 (CTCAE v 3.0) Grade 4 (CTCAE v 3.0)
Hide Arm/Group Description:
Number of patients who did not experience the specified AE.
Number of patients who experienced a grade 1 event using Common Terminology Criteria for Adverse Events v3.0 (CTCAE).
Number of patients who experienced a grade 2 event using Common Terminology Criteria for Adverse Events v3.0 (CTCAE).
Number of patients who experienced a grade 3 event using Common Terminology Criteria for Adverse Events v3.0 (CTCAE).
Number of patients who experienced a grade 4 event using Common Terminology Criteria for Adverse Events v3.0 (CTCAE).
Overall Number of Participants Analyzed 20 20 20 20 20
Measure Type: Number
Unit of Measure: participants
Leukopenia 2 0 7 10 1
Thrombocytopenia 13 4 0 3 0
Neutropenia 2 0 2 11 5
Anemia 3 10 6 1 0
Other hematologic 18 0 2 0 0
Coagulation 19 1 0 0 0
Hemorrhage 18 2 0 0 0
Nausea 3 11 6 0 0
Vomiting 7 10 3 0 0
Bilirubin 19 1 0 0 0
ALT 9 4 5 2 0
Alkaline Phosphatase 19 1 0 0 0
Dermatologic 14 4 2 0 0
Infection 17 0 2 1 0
Pulmonary 15 4 1 0 0
Metabolic 8 5 4 3 0
Lymphatics 16 4 0 0 0
Pain 8 10 2 0 0
Constitutional 17 3 0 0 0
Fatigue 5 8 7 0 0
Musculoskeletal 15 4 1 0 0
Neurotoxicity 16 4 0 0 0
Peripheral neuropathy 18 2 0 0 0
Renal 19 1 0 0 0
Ocular 16 3 1 0 0
Vascular 19 0 0 1 0
Flu-like syndrome 19 0 1 0 0
Time Frame Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Trabectidin
Hide Arm/Group Description Trabectedin 1.5 mg/m2 IV over 24 hours every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy
All-Cause Mortality
Trabectidin
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Trabectidin
Affected / at Risk (%)
Total   4/20 (20.00%) 
Blood and lymphatic system disorders   
Neutrophils * 1  2/20 (10.00%) 
Gastrointestinal disorders   
Diarrhea * 1  1/20 (5.00%) 
Infections and infestations   
Inf W/Nml Or Gr 1 Or 2 Anc: Neck Nos * 1  1/20 (5.00%) 
Metabolism and nutrition disorders   
Hypokalemia * 1  1/20 (5.00%) 
Vascular disorders   
Thrombosis/Thrombus/Embolism * 1  1/20 (5.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Trabectidin
Affected / at Risk (%)
Total   20/20 (100.00%) 
Blood and lymphatic system disorders   
Neutrophils * 1  18/20 (90.00%) 
Platelets * 1  8/20 (40.00%) 
Leukocytes * 1  18/20 (90.00%) 
Lymphopenia * 1  2/20 (10.00%) 
Hemoglobin * 1  17/20 (85.00%) 
Edema: Limb * 1  5/20 (25.00%) 
Edema: Head And Neck * 1  1/20 (5.00%) 
Cardiac disorders   
Palpitations * 1  1/20 (5.00%) 
Cardiac Arrhythmia - Other * 1  1/20 (5.00%) 
Ventricular Arrhythmia - Tachycardia * 1  1/20 (5.00%) 
Hypertension * 1  1/20 (5.00%) 
Cardiac General - Other * 1  1/20 (5.00%) 
Hypotension * 1  1/20 (5.00%) 
Ear and labyrinth disorders   
Tinnitus * 1  1/20 (5.00%) 
Endocrine disorders   
Hot Flashes * 1  3/20 (15.00%) 
Eye disorders   
Ocular/Visual - Other * 1  1/20 (5.00%) 
Flashing Lights/Floaters * 1  1/20 (5.00%) 
Blurred Vision * 1  3/20 (15.00%) 
Gastrointestinal disorders   
Flatulence * 1  2/20 (10.00%) 
Gastritis * 1  1/20 (5.00%) 
Hemorrhoids * 1  1/20 (5.00%) 
Heartburn * 1  2/20 (10.00%) 
Dysphagia * 1  1/20 (5.00%) 
Distention * 1  1/20 (5.00%) 
Taste Alteration * 1  2/20 (10.00%) 
Mucositis (Functional/Sympt) - Oral Cavity * 1  1/20 (5.00%) 
Obstruction, Gi - Small Bowel Nos * 1  1/20 (5.00%) 
Mucositis (Clinical Exam) - Oral Cavity * 1  1/20 (5.00%) 
Vomiting * 1  13/20 (65.00%) 
Anorexia * 1  6/20 (30.00%) 
Dehydration * 1  1/20 (5.00%) 
Constipation * 1  14/20 (70.00%) 
Nausea * 1  17/20 (85.00%) 
Gastrointestinal - Other * 1  2/20 (10.00%) 
Diarrhea * 1  8/20 (40.00%) 
General disorders   
Weight Gain * 1  4/20 (20.00%) 
Fever * 1  2/20 (10.00%) 
Weight Loss * 1  2/20 (10.00%) 
Rigors/Chills * 1  1/20 (5.00%) 
Fatigue * 1  16/20 (80.00%) 
Pain - Other * 1  1/20 (5.00%) 
Pain: Pelvis * 1  2/20 (10.00%) 
Pain: Chest /Thorax Nos * 1  1/20 (5.00%) 
Pain: Chest Wall * 1  2/20 (10.00%) 
Pain: Throat/Pharynx/Larynx * 1  2/20 (10.00%) 
Pain: Head/Headache * 1  9/20 (45.00%) 
Pain: Neck * 1  2/20 (10.00%) 
Pain: Extremity-Limb * 1  6/20 (30.00%) 
Pain: Back * 1  3/20 (15.00%) 
Pain: Joint * 1  5/20 (25.00%) 
Pain: Stomach * 1  1/20 (5.00%) 
Pain: Oral Cavity * 1  3/20 (15.00%) 
Pain: Abdominal Pain Nos * 1  3/20 (15.00%) 
Pain: Liver * 1  1/20 (5.00%) 
Pain: Muscle * 1  3/20 (15.00%) 
Flu-Like Syndrome * 1  1/20 (5.00%) 
Immune system disorders   
Rhinitis * 1  1/20 (5.00%) 
Infections and infestations   
Febrile Neutropenia * 1  1/20 (5.00%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Urinary Tract Nos * 1  1/20 (5.00%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Pharynx * 1  1/20 (5.00%) 
Metabolism and nutrition disorders   
Ast * 1  10/20 (50.00%) 
Metabolic/Laboratory - Other * 1  3/20 (15.00%) 
Cholesterol,serum High * 1  1/20 (5.00%) 
Proteinuria * 1  2/20 (10.00%) 
Creatinine * 1  1/20 (5.00%) 
Hypoalbuminemia * 1  3/20 (15.00%) 
Alt * 1  12/20 (60.00%) 
Alkaline Phosphatase * 1  1/20 (5.00%) 
Bilirubin * 1  1/20 (5.00%) 
Hypophosphatemia * 1  1/20 (5.00%) 
Hyponatremia * 1  3/20 (15.00%) 
Cpk * 1  1/20 (5.00%) 
Hypocalcemia * 1  2/20 (10.00%) 
Hyperglycemia * 1  6/20 (30.00%) 
Hypokalemia * 1  3/20 (15.00%) 
Hypomagnesemia * 1  3/20 (15.00%) 
Musculoskeletal and connective tissue disorders   
Musculoskeletal/St: Other * 1  1/20 (5.00%) 
Muscle Weakness - Whole Body/Generalized * 1  2/20 (10.00%) 
Muscle Weakness - Extremity-Upper * 1  1/20 (5.00%) 
Muscle Weakness - Extremity-Lower * 1  3/20 (15.00%) 
Nervous system disorders   
Neurology - Other * 1  2/20 (10.00%) 
Mood Alteration - Depression * 1  4/20 (20.00%) 
Mood Alteration - Anxiety * 1  2/20 (10.00%) 
Mood Alteration - Agitation * 1  1/20 (5.00%) 
Dizziness * 1  1/20 (5.00%) 
Neuropathy-Sensory * 1  5/20 (25.00%) 
Neuropathy-Motor * 1  2/20 (10.00%) 
Renal and urinary disorders   
Renal/Genitourinary - Other * 1  1/20 (5.00%) 
Urinary Frequency * 1  1/20 (5.00%) 
Reproductive system and breast disorders   
Vaginal Discharge * 1  1/20 (5.00%) 
Respiratory, thoracic and mediastinal disorders   
Pulmonary: Other * 1  1/20 (5.00%) 
Pneumothorax * 1  1/20 (5.00%) 
Cough * 1  4/20 (20.00%) 
Dyspnea * 1  7/20 (35.00%) 
Skin and subcutaneous tissue disorders   
Hair Loss/Alopecia (Scalp Or Body) * 1  1/20 (5.00%) 
Erythema Multiforme * 1  1/20 (5.00%) 
Bruising * 1  2/20 (10.00%) 
Rash * 1  3/20 (15.00%) 
Dry Skin * 1  1/20 (5.00%) 
Flushing * 1  2/20 (10.00%) 
Dermatology/Skin - Other * 1  1/20 (5.00%) 
Hyperpigmentation * 1  2/20 (10.00%) 
Vascular disorders   
Inr * 1  2/20 (10.00%) 
Ptt * 1  1/20 (5.00%) 
Hemorrhage, Gi - Rectum * 1  1/20 (5.00%) 
Hemorrhage/Pulmonary - Nose * 1  2/20 (10.00%) 
Vascular - Other * 1  1/20 (5.00%) 
Thrombosis/Embolism (Vascular Access-Related) * 1  2/20 (10.00%) 
Thrombosis/Thrombus/Embolism * 1  1/20 (5.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (3.0)
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 Kuras on behalf of James Kauderer
Organization: NRG Oncology
Phone: 716-845-5702
EMail: kurasa@nrgoncology.org
Layout table for additonal information
Responsible Party: GOG Foundation ( Gynecologic Oncology Group )
ClinicalTrials.gov Identifier: NCT00379145    
Other Study ID Numbers: GOG-0087M
CDR0000502192 ( Other Identifier: CDR )
NCI-2009-00573 ( Other Identifier: NCI )
First Submitted: September 19, 2006
First Posted: September 21, 2006
Results First Submitted: October 13, 2017
Results First Posted: December 12, 2017
Last Update Posted: December 12, 2017