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Trabectedin in Treating Young Patients With Recurrent or Refractory Soft Tissue Sarcoma or Ewing's Family of Tumors

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ClinicalTrials.gov Identifier: NCT00070109
Recruitment Status : Completed
First Posted : October 7, 2003
Results First Posted : January 27, 2014
Last Update Posted : September 14, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Previously Treated Childhood Rhabdomyosarcoma
Recurrent Childhood Rhabdomyosarcoma
Recurrent Childhood Soft Tissue Sarcoma
Recurrent Ewing Sarcoma
Peripheral Primitive Neuroectodermal Tumor
Interventions Drug: trabectedin
Other: pharmacological study
Enrollment 50

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Trabectedin 1.3 mg/m2 to Assess Feasibility in All Patients Trabectedin 1.5 mg/m2 to Assess Feasibility in All Patients Trabectedin at 1.5 mg/m2 to Assess Efficacy in Ewing Sarcoma Trabectedin at 1.5 mg/m2 - Assess Efficacy in Rhabdomyosarcoma Trabectedin 1.5 mg/m2 - Assess Efficacy in Nonrhabdomyosarcoma
Hide Arm/Group Description

Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity. A cohort of 6 patients will be enrolled at the 1.3 mg/m2 dose level.

trabectedin: Given IV

pharmacological study: Correlative studies

Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity. Six toxicity-evaluable patients are assigned this treatment.

trabectedin: Given IV

Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.

trabectedin: Given IV

Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.

trabectedin: Given IV

Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.

trabectedin: Given IV

Period Title: Overall Study
Started 8 6 8 20 8
Completed 0 0 0 0 0
Not Completed 8 6 8 20 8
Reason Not Completed
Death             1             1             0             0             1
Lack of Efficacy             6             4             5             15             5
Physician Decision             1             0             0             0             0
Withdrawal by Subject             0             1             1             0             0
Adverse Event             0             0             2             4             2
removed from prot thpy prior to chemo             0             0             0             1             0
Arm/Group Title Trabectedin 1.3 mg/m2 to Assess Feasibility in All Patients Trabectedin 1.5 mg/m2 to Assess Feasibility in All Patients Trabectedin at 1.5 mg/m2 to Assess Efficacy in Ewing Sarcoma Trabectedin at 1.5 mg/m2 - Assess Efficacy in Rhabdomyosarcoma Trabectedin 1.5 mg/m2 - Assess Efficacy in Nonrhabdomyosarcoma Total
Hide Arm/Group Description

Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.

trabectedin: Given IV

pharmacological study: Correlative studies

Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.

trabectedin: Given IV

Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.

trabectedin: Given IV

Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.

trabectedin: Given IV

Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.

trabectedin: Given IV

Total of all reporting groups
Overall Number of Baseline Participants 8 6 8 20 8 50
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 8 participants 6 participants 8 participants 20 participants 8 participants 50 participants
18.5
(8 to 24)
15.5
(8 to 21)
16
(8 to 20)
14.5
(4 to 22)
16
(8 to 21)
15.5
(4 to 24)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 6 participants 8 participants 20 participants 8 participants 50 participants
Female
1
  12.5%
2
  33.3%
3
  37.5%
11
  55.0%
2
  25.0%
19
  38.0%
Male
7
  87.5%
4
  66.7%
5
  62.5%
9
  45.0%
6
  75.0%
31
  62.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 6 participants 8 participants 20 participants 8 participants 50 participants
Hispanic or Latino
0
   0.0%
1
  16.7%
0
   0.0%
3
  15.0%
3
  37.5%
7
  14.0%
Not Hispanic or Latino
8
 100.0%
5
  83.3%
0
   0.0%
16
  80.0%
5
  62.5%
34
  68.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
8
 100.0%
1
   5.0%
0
   0.0%
9
  18.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 6 participants 8 participants 20 participants 8 participants 50 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
1
  12.5%
1
   5.0%
0
   0.0%
2
   4.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
  12.5%
0
   0.0%
0
   0.0%
5
  25.0%
1
  12.5%
7
  14.0%
White
6
  75.0%
6
 100.0%
7
  87.5%
12
  60.0%
7
  87.5%
38
  76.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
  12.5%
0
   0.0%
0
   0.0%
2
  10.0%
0
   0.0%
3
   6.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 8 participants 6 participants 8 participants 20 participants 8 participants 50 participants
United States 5 6 5 19 8 43
Canada 3 0 3 1 0 7
1.Primary Outcome
Title Response (Complete Response [CR] and Partial Response [PR])
Hide Description Any patient who is enrolled and receives at least one dose of trabectedin will be considered evaluable for response if the individual receives at least one dose of trabectedin and: (1) is removed from protocol therapy because of progressive disease where progressive disease is documented either by imaging studies or clinical progression; or (2) has at least one radiographic evaluation of disease status after the start of protocol therapy and is not electively removed from protocol therapy with stable disease or is not lost to follow-up with stable disease. Patients who achieve a complete response (CR) - disappearance of all target lesions or partial response (PR) - >=30% decrease in the sum of the longest diameter of target lesions according to the RECIST criteria will be considered responders for the study design. All other patients who are evaluable for response will be considered non-responders for the study.
Time Frame Twenty-six (26) cycles of chemotherapy or termination of protocol therapy, whichever occurs first.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
No pts in Group 1 were evaluated for response. 1 pt in Group 3 is excluded because the pt was removed from protocol therapy after cycle 3 when a cardiac evaluation was missed. The pt was removed prior to disease assessment on protocol therapy. 1 pt enrolled in Group 4 was excluded because patient was removed from therapy prior to chemotherapy.
Arm/Group Title Trabectedin 1.5 mg/m2- Feasibility in All Patients(Group 2) Trabectedin 1.5 mg/m2- Efficacy in Ewing Sarcoma (Group 3) Trabectedin 1.5 mg/m2- Efficacy in Rhabdomyosarcoma (Group 4) Trabectedin 1.5 mg/m2-efficacy in Nonrhabdomyosarcoma(Group 5)
Hide Arm/Group Description:

Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.

trabectedin: Given IV

Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.

trabectedin: Given IV

Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.

trabectedin: Given IV

Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.

trabectedin: Given IV

Overall Number of Participants Analyzed 6 7 19 8
Measure Type: Number
Unit of Measure: participants
1 0 0 0
2.Primary Outcome
Title Number of Patients With Dose-Limiting Toxicity (DLT)
Hide Description Any Grade 3 or Grade 4 non-hematologic toxicity attributable to the Investigational drug with the specific exclusion of: Grade 3 nausea and vomiting; Grade 3 transaminase (AST/ALT) elevation that return to less than or equal to Grade 1 or baseline prior to the time for the next treatment cycle; Grade 3 fever or infection; Alopecia; Grade 4 neutropenia of > 7 days duration or Grade 4 thrombocytopenia of > 7 days duration, which requires transfusion therapy on greater than 2 occasions in 7 days, or which causes a delay of more than 14 days beyond the planned interval between treatment cycles.
Time Frame 1 Cycle
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Two pts in Group 1 and 1 pt in Group 2 were excluded because they were removed from therapy prior to the DLT evaluation period and no DLT had been observed. No patients in Groups 3, 4, or 5 were evaluated for DLT.
Arm/Group Title Trabectedin 1.3 mg/m2- Feasibility in All Patients (Group 1) Trabectedin 1.5 mg/m2- Feasibility in All Patients (Group 2)
Hide Arm/Group Description:

Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.

trabectedin: Given IV

pharmacological study: Correlative studies

Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity. Six toxicity-evaluable patients are assigned this treatment.

trabectedin: Given IV

Overall Number of Participants Analyzed 6 5
Measure Type: Number
Unit of Measure: participants
1 0
3.Primary Outcome
Title Pharmacokinetics by a Miniaturized Liquid Chromatography/Tandem Mass Spectrometry Method : Maximum Plasma Concentration (Cmax) of Trabectedin
Hide Description The plasma concentrations at each time point were determined by miniaturized Liquid Chromatography/Tandem Mass Spectrometry Method. The plasma concentration-versus-time data of trabectedin were estimated using non-compartmental methods. Individual time points were not available, so one estimated Cmax was derived for each patient.
Time Frame From baseline up to168 hours after trabectedin infusion in course 1
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients for whom specimens were submitted to the pharmacokinetics laboratory with sufficient samples to calculate maximum plasma concentration of trabectedin. Group 1 and group 2 patients were excluded due to not submitting specimens.
Arm/Group Title Trabectedin at 1.5 mg/m2- Efficacy in Ewing Sarcoma (Group 3) Trabectedin 1.5 mg/m2- Efficacy in Rhabdomyosarcoma (Group 4) Trabectedin 1.5 mg/m2-efficacy in Nonrhabdomyosarcoma(Group 5)
Hide Arm/Group Description:
Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 3 2 5
Mean (Standard Deviation)
Unit of Measure: ng/mL
3.643333333  (4.08) 2.285  (0.191) 1.889  (1.26)
4.Primary Outcome
Title Pharmacokinetics by a Miniaturized Liquid Chromatography/Tandem Mass Spectrometry Method : Apparent Volume at Steady State (Vss) of Trabectedin
Hide Description The plasma concentrations at each time point were determined by miniaturized Liquid Chromatography/Tandem Mass Spectrometry Method. The plasma concentration-versus-time data of trabectedin were estimated using non-compartmental methods. Individual time points were not available, so one estimated Vss was derived for each patient.
Time Frame From baseline up to168 hours after trabectedin infusion in course 1
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients for whom specimens were submitted to the pharmacokinetics laboratory with sufficient samples to calculate apparent volume at steady state of trabectedin of trabectedin. Group 1 and group 2 patients were excluded due to not submitting specimens.
Arm/Group Title Trabectedin at 1.5 mg/m2- Efficacy in Ewing Sarcoma (Group 3) Trabectedin 1.5 mg/m2- Efficacy in Rhabdomyosarcoma (Group 4) Trabectedin 1.5 mg/m2-efficacy in Nonrhabdomyosarcoma(Group 5)
Hide Arm/Group Description:
Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 3 2 2
Mean (Standard Deviation)
Unit of Measure: L
1860.666667  (999.9) 1340.5  (439) 3269.5  (269.4)
5.Primary Outcome
Title Pharmacokinetics by a Miniaturized Liquid Chromatography/Tandem Mass Spectrometry Method : Half-life of Trabectedin
Hide Description The plasma concentrations at each time point were determined by miniaturized Liquid Chromatography/Tandem Mass Spectrometry Method. The plasma concentration-versus-time data of trabectedin were estimated using non-compartmental methods. Individual time points were not available, so one estimated Half-life was derived for each patient.
Time Frame From baseline up to168 hours after trabectedin infusion in course 1
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients for whom specimens were submitted to the pharmacokinetics laboratory with sufficient samples to calculate trabectedin half life. Group 1 and group 2 patients were excluded due to not submitting specimens.
Arm/Group Title Trabectedin at 1.5 mg/m2- Efficacy in Ewing Sarcoma (Group 3) Trabectedin 1.5 mg/m2- Efficacy in Rhabdomyosarcoma (Group 4) Trabectedin 1.5 mg/m2-efficacy in Nonrhabdomyosarcoma(Group 5)
Hide Arm/Group Description:
Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 3 2 2
Mean (Standard Deviation)
Unit of Measure: hours
47.4  (17.0) 49.5  (1.70) 63.4  (22.4)
6.Primary Outcome
Title Pharmacokinetics by a Miniaturized Liquid Chromatography/Tandem Mass Spectrometry Method : Area Under the Curve (AUC) of Trabectedin
Hide Description The plasma concentrations at each time point were determined by miniaturized Liquid Chromatography/Tandem Mass Spectrometry Method. The plasma concentration-versus-time data of trabectedin were estimated using non-compartmental methods. Individual time points were not available, so one estimated AUC was derived for each patient.
Time Frame From baseline up to168 hours after trabectedin infusion in course 1
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients for whom specimens were submitted to the pharmacokinetics laboratory with sufficient samples to calculate trabectedin AUC. Group 1 and group 2 patients were excluded due to not submitting specimens.
Arm/Group Title Trabectedin at 1.5 mg/m2- Efficacy in Ewing Sarcoma (Group 3) Trabectedin 1.5 mg/m2- Efficacy in Rhabdomyosarcoma (Group 4) Trabectedin 1.5 mg/m2-efficacy in Nonrhabdomyosarcoma(Group 5)
Hide Arm/Group Description:
Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 3 2 2
Mean (Standard Deviation)
Unit of Measure: ng/(mLxh)
184.9  (193) 75.7  (43.3) 41.2  (18.7)
7.Primary Outcome
Title Pharmacokinetics by a Miniaturized Liquid Chromatography/Tandem Mass Spectrometry Method : Clearance of Trabectedin
Hide Description The plasma concentrations at each time point were determined by miniaturized Liquid Chromatography/Tandem Mass Spectrometry Method. The plasma concentration-versus-time data of trabectedin were estimated using non-compartmental methods. Individual time points were not available, so one estimated Clearance was derived for each patient.
Time Frame From baseline up to168 hours after trabectedin infusion in course 1
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients for whom specimens were submitted to the pharmacokinetics laboratory with sufficient samples to calculate trabectedin clearance. Group 1 and group 2 patients were excluded due to not submitting specimens.
Arm/Group Title Trabectedin at 1.5 mg/m2 to Assess Efficacy in Ewing Sarcoma Trabectedin at 1.5 mg/m2 - Assess Efficacy in Rhabdomyosarcoma Trabectedin 1.5 mg/m2 - Assess Efficacy in Nonrhabdomyosarcoma
Hide Arm/Group Description:
Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 3 2 2
Mean (Standard Deviation)
Unit of Measure: L/hr
20.5786891  (17.9) 18.11833775  (3.32) 63.8304367  (29.7)
Time Frame [Not Specified]
Adverse Event Reporting Description 1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
 
Arm/Group Title Trabectedin 1.3 mg/m2 to Assess Feasibility in All Patients Trabectedin 1.5 mg/m2 to Assess Feasibility in All Patients Trabectedin at 1.5 mg/m2 to Assess Efficacy in Ewing Sarcoma Trabectedin at 1.5 mg/m2 - Assess Efficacy in Rhabdomyosarcoma Trabectedin 1.5 mg/m2 - Assess Efficacy in Nonrhabdomyosarcoma
Hide Arm/Group Description

Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.

trabectedin: Given IV

pharmacological study: Correlative studies

Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.

trabectedin: Given IV

Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.

trabectedin: Given IV

Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.

trabectedin: Given IV

Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.

trabectedin: Given IV

All-Cause Mortality
Trabectedin 1.3 mg/m2 to Assess Feasibility in All Patients Trabectedin 1.5 mg/m2 to Assess Feasibility in All Patients Trabectedin at 1.5 mg/m2 to Assess Efficacy in Ewing Sarcoma Trabectedin at 1.5 mg/m2 - Assess Efficacy in Rhabdomyosarcoma Trabectedin 1.5 mg/m2 - Assess Efficacy in Nonrhabdomyosarcoma
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Trabectedin 1.3 mg/m2 to Assess Feasibility in All Patients Trabectedin 1.5 mg/m2 to Assess Feasibility in All Patients Trabectedin at 1.5 mg/m2 to Assess Efficacy in Ewing Sarcoma Trabectedin at 1.5 mg/m2 - Assess Efficacy in Rhabdomyosarcoma Trabectedin 1.5 mg/m2 - Assess Efficacy in Nonrhabdomyosarcoma
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/8 (37.50%)   0/6 (0.00%)   1/8 (12.50%)   5/19 (26.32%)   3/8 (37.50%) 
Eye disorders           
Eye pain  0/8 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  1/19 (5.26%)  0/8 (0.00%) 
General disorders           
Death NOS  1/8 (12.50%)  0/6 (0.00%)  0/8 (0.00%)  0/19 (0.00%)  1/8 (12.50%) 
Fever  0/8 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  1/19 (5.26%)  0/8 (0.00%) 
Infections and infestations           
Infections and infestations - Other, specify  0/8 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  1/19 (5.26%)  0/8 (0.00%) 
Injury, poisoning and procedural complications           
Vascular access complication  0/8 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  0/19 (0.00%)  1/8 (12.50%) 
Investigations           
Alanine aminotransferase increased  1/8 (12.50%)  0/6 (0.00%)  1/8 (12.50%)  1/19 (5.26%)  0/8 (0.00%) 
Aspartate aminotransferase increased  1/8 (12.50%)  0/6 (0.00%)  1/8 (12.50%)  2/19 (10.53%)  0/8 (0.00%) 
GGT increased  1/8 (12.50%)  0/6 (0.00%)  1/8 (12.50%)  1/19 (5.26%)  0/8 (0.00%) 
Lymphocyte count decreased  0/8 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  1/19 (5.26%)  0/8 (0.00%) 
Metabolism and nutrition disorders           
Dehydration  0/8 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  1/19 (5.26%)  0/8 (0.00%) 
Hyperglycemia  0/8 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  1/19 (5.26%)  0/8 (0.00%) 
Hyponatremia  1/8 (12.50%)  0/6 (0.00%)  0/8 (0.00%)  0/19 (0.00%)  0/8 (0.00%) 
Musculoskeletal and connective tissue disorders           
Back pain  0/8 (0.00%)  0/6 (0.00%)  1/8 (12.50%)  0/19 (0.00%)  0/8 (0.00%) 
Renal and urinary disorders           
Acute kidney injury  0/8 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  0/19 (0.00%)  1/8 (12.50%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Trabectedin 1.3 mg/m2 to Assess Feasibility in All Patients Trabectedin 1.5 mg/m2 to Assess Feasibility in All Patients Trabectedin at 1.5 mg/m2 to Assess Efficacy in Ewing Sarcoma Trabectedin at 1.5 mg/m2 - Assess Efficacy in Rhabdomyosarcoma Trabectedin 1.5 mg/m2 - Assess Efficacy in Nonrhabdomyosarcoma
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   6/8 (75.00%)   4/6 (66.67%)   6/8 (75.00%)   15/19 (78.95%)   6/8 (75.00%) 
Blood and lymphatic system disorders           
Anemia  4/8 (50.00%)  2/6 (33.33%)  3/8 (37.50%)  5/19 (26.32%)  1/8 (12.50%) 
Eye disorders           
Blurred vision  0/8 (0.00%)  1/6 (16.67%)  0/8 (0.00%)  0/19 (0.00%)  0/8 (0.00%) 
Eye disorders - Other, specify  0/8 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  1/19 (5.26%)  0/8 (0.00%) 
Gastrointestinal disorders           
Abdominal distension  0/8 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  1/19 (5.26%)  0/8 (0.00%) 
Abdominal pain  0/8 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  1/19 (5.26%)  1/8 (12.50%) 
Constipation  0/8 (0.00%)  1/6 (16.67%)  1/8 (12.50%)  0/19 (0.00%)  0/8 (0.00%) 
Diarrhea  1/8 (12.50%)  0/6 (0.00%)  0/8 (0.00%)  1/19 (5.26%)  0/8 (0.00%) 
Dry mouth  0/8 (0.00%)  1/6 (16.67%)  0/8 (0.00%)  0/19 (0.00%)  0/8 (0.00%) 
Flatulence  0/8 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  0/19 (0.00%)  1/8 (12.50%) 
Nausea  0/8 (0.00%)  1/6 (16.67%)  0/8 (0.00%)  4/19 (21.05%)  0/8 (0.00%) 
Upper gastrointestinal hemorrhage  1/8 (12.50%)  0/6 (0.00%)  0/8 (0.00%)  0/19 (0.00%)  0/8 (0.00%) 
Vomiting  1/8 (12.50%)  1/6 (16.67%)  1/8 (12.50%)  4/19 (21.05%)  0/8 (0.00%) 
General disorders           
Fatigue  1/8 (12.50%)  1/6 (16.67%)  1/8 (12.50%)  1/19 (5.26%)  1/8 (12.50%) 
Fever  1/8 (12.50%)  1/6 (16.67%)  0/8 (0.00%)  0/19 (0.00%)  0/8 (0.00%) 
Non-cardiac chest pain  0/8 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  1/19 (5.26%)  1/8 (12.50%) 
Pain  0/8 (0.00%)  1/6 (16.67%)  1/8 (12.50%)  0/19 (0.00%)  1/8 (12.50%) 
Infections and infestations           
Bladder infection  0/8 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  1/19 (5.26%)  0/8 (0.00%) 
Infections and infestations - Other, specify  3/8 (37.50%)  0/6 (0.00%)  0/8 (0.00%)  0/19 (0.00%)  0/8 (0.00%) 
Mucosal infection  0/8 (0.00%)  1/6 (16.67%)  0/8 (0.00%)  1/19 (5.26%)  1/8 (12.50%) 
Injury, poisoning and procedural complications           
Vascular access complication  0/8 (0.00%)  0/6 (0.00%)  1/8 (12.50%)  0/19 (0.00%)  0/8 (0.00%) 
Investigations           
Activated partial thromboplastin time prolonged  0/8 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  1/19 (5.26%)  0/8 (0.00%) 
Alanine aminotransferase increased  3/8 (37.50%)  3/6 (50.00%)  1/8 (12.50%)  9/19 (47.37%)  3/8 (37.50%) 
Alkaline phosphatase increased  1/8 (12.50%)  0/6 (0.00%)  0/8 (0.00%)  0/19 (0.00%)  0/8 (0.00%) 
Aspartate aminotransferase increased  3/8 (37.50%)  3/6 (50.00%)  1/8 (12.50%)  6/19 (31.58%)  3/8 (37.50%) 
Blood bilirubin increased  0/8 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  1/19 (5.26%)  0/8 (0.00%) 
CPK increased  1/8 (12.50%)  0/6 (0.00%)  0/8 (0.00%)  0/19 (0.00%)  0/8 (0.00%) 
Creatinine increased  0/8 (0.00%)  0/6 (0.00%)  1/8 (12.50%)  0/19 (0.00%)  0/8 (0.00%) 
GGT increased  1/8 (12.50%)  0/6 (0.00%)  0/8 (0.00%)  5/19 (26.32%)  3/8 (37.50%) 
Investigations - Other, specify  0/8 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  1/19 (5.26%)  0/8 (0.00%) 
Lymphocyte count decreased  1/8 (12.50%)  1/6 (16.67%)  1/8 (12.50%)  4/19 (21.05%)  2/8 (25.00%) 
Neutrophil count decreased  4/8 (50.00%)  2/6 (33.33%)  2/8 (25.00%)  10/19 (52.63%)  2/8 (25.00%) 
Platelet count decreased  0/8 (0.00%)  0/6 (0.00%)  2/8 (25.00%)  5/19 (26.32%)  0/8 (0.00%) 
White blood cell decreased  3/8 (37.50%)  1/6 (16.67%)  2/8 (25.00%)  9/19 (47.37%)  2/8 (25.00%) 
Metabolism and nutrition disorders           
Acidosis  0/8 (0.00%)  0/6 (0.00%)  1/8 (12.50%)  0/19 (0.00%)  0/8 (0.00%) 
Anorexia  1/8 (12.50%)  0/6 (0.00%)  0/8 (0.00%)  2/19 (10.53%)  0/8 (0.00%) 
Hypercalcemia  0/8 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  1/19 (5.26%)  0/8 (0.00%) 
Hyperglycemia  1/8 (12.50%)  0/6 (0.00%)  0/8 (0.00%)  3/19 (15.79%)  0/8 (0.00%) 
Hypermagnesemia  0/8 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  1/19 (5.26%)  0/8 (0.00%) 
Hypoalbuminemia  1/8 (12.50%)  1/6 (16.67%)  1/8 (12.50%)  0/19 (0.00%)  0/8 (0.00%) 
Hypokalemia  1/8 (12.50%)  0/6 (0.00%)  1/8 (12.50%)  1/19 (5.26%)  0/8 (0.00%) 
Hypophosphatemia  2/8 (25.00%)  0/6 (0.00%)  0/8 (0.00%)  0/19 (0.00%)  0/8 (0.00%) 
Musculoskeletal and connective tissue disorders           
Back pain  0/8 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  1/19 (5.26%)  0/8 (0.00%) 
Buttock pain  0/8 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  1/19 (5.26%)  0/8 (0.00%) 
Myalgia  1/8 (12.50%)  0/6 (0.00%)  0/8 (0.00%)  1/19 (5.26%)  0/8 (0.00%) 
Pain in extremity  2/8 (25.00%)  1/6 (16.67%)  1/8 (12.50%)  0/19 (0.00%)  0/8 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Tumor Pain  2/8 (25.00%)  0/6 (0.00%)  1/8 (12.50%)  1/19 (5.26%)  0/8 (0.00%) 
Nervous system disorders           
Dizziness  0/8 (0.00%)  1/6 (16.67%)  0/8 (0.00%)  0/19 (0.00%)  0/8 (0.00%) 
Dysgeusia  1/8 (12.50%)  0/6 (0.00%)  0/8 (0.00%)  0/19 (0.00%)  0/8 (0.00%) 
Encephalopathy  0/8 (0.00%)  1/6 (16.67%)  0/8 (0.00%)  0/19 (0.00%)  0/8 (0.00%) 
Neuralgia  0/8 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  1/19 (5.26%)  0/8 (0.00%) 
Peripheral sensory neuropathy  0/8 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  1/19 (5.26%)  0/8 (0.00%) 
Psychiatric disorders           
Anxiety  0/8 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  1/19 (5.26%)  0/8 (0.00%) 
Respiratory, thoracic and mediastinal disorders           
Cough  0/8 (0.00%)  1/6 (16.67%)  0/8 (0.00%)  0/19 (0.00%)  0/8 (0.00%) 
Dyspnea  0/8 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  2/19 (10.53%)  0/8 (0.00%) 
Vascular disorders           
Phlebitis  0/8 (0.00%)  0/6 (0.00%)  1/8 (12.50%)  0/19 (0.00%)  1/8 (12.50%) 
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.
Must obtain prior Sponsor approval.
Results Point of Contact
Name/Title: Results Reporting Coordinator
Organization: Children's Oncology Group
Phone: 352-273-0558
Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00070109     History of Changes
Other Study ID Numbers: ADVL0221
NCI-2009-00357 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000329999 ( Other Identifier: Clinical Trials.gov )
COG-ADVL0221 ( Other Identifier: Children's Oncology Group )
U10CA098543 ( U.S. NIH Grant/Contract )
First Submitted: October 3, 2003
First Posted: October 7, 2003
Results First Submitted: December 9, 2013
Results First Posted: January 27, 2014
Last Update Posted: September 14, 2018